Neelu is the WW Vice President of Regulatory Affairs at BD. In addition, she has many years of experience working in Regulatory Affairs for J&J. Although life sciences weren’t originally her niche, she was drawn into a long and fruitful career in the medical device industry.

Listen to the episode to learn about how Neelu progressed to her current role and how she entered the life sciences industry in the first place.  Learn why she finds regulatory affairs exciting, and get advice on who to learn and lead in a new environment at a large company, even when you are not a subject matter expert.

• What inspired Neelu to a career in the life sciences, and the companies she worked for
• How Neelu took ownership of her leadership role
• What excites Neelu about regulatory affairs
• Neelu's approach to learning and how she "learns beyond the job"
• Mentors that helped Neelu along her career journey
• Advice for career advancement
• How to navigate difficult conversations
• Recommendations for taking risks

Mike: Our guest today is the Worldwide Vice President of Regulatory Affairs at BD, having served in that role since 2020. We are going to welcome Neelu Gibson to the podcast.

Recognized as a strong results-oriented executive, Neelu has enjoyed an impressive career highlighted by obtaining multiple PMA approvals and 510(k) clearances from the US FDA and similar approvals from international regulatory agencies. During her 20+ years with J&J, Neelu served on five management boards holding leadership positions in Regulatory Affairs at seven J&J companies.

Prior to joining BD, Neelu was most recently the head of Regulatory Affairs for J&J Surgical Vision. Neelu has a BS in Environmental Sciences from the College of Northeast London located in the UK. She is a certified Regulatory Affairs professional and an active member of Device Alliance, RAPS, and OCRA.

Neelu also continues to coach and mentor Regulatory Affairs professionals along their own leadership journeys. Let's welcome to the podcast, Neelu Gibson. Welcome, Neelu. We're glad to have you.

Neelu: Thank you so much for having me.

Mike: Thank you. Let's jump right in. I'll get started with an easy one here. I want to learn a little bit more about your journey in the life sciences industry and how you got into the industry in the first place.

Neelu: Actually, it's been a very interesting journey from the standpoint of I never woke up and said, you know, I want to be a Regulatory Affairs professional. My background, actually as you mentioned, was environmental health, environmental science.

In England, I actually studied to be a health inspector. We did inspections of food, housing, pollution, stuff like that. I came stateside. My first role was actually at UCI, where I was (again) working on biosafety, et cetera. Falling into RA was actually unique from the standpoint that I was actually presenting to one of the management teams about an inspection that we were having.

The Vice President of RA approached me at the end of that meeting and said, you work with the Department of Toxic Substances and the EPA. You would be a really good fit for coming across Reg Affairs. Now, I had no idea who the Food and Drug Administration was at the time, but I decided to take a leap of faith. You'll hear me say that a lot into a career that I knew nothing about. I fell in love with it and I've been doing it ever since.

Mike: That's awesome. I know you are a follower of Simon Sinek. He espouses that philosophy of finding your why. I'm wondering maybe that's what happened along the way in that journey.

Neelu: Yeah, it did. It was interesting, because we talked about writing mission statements, knowing where you want to go, and all of the rest of it. I'd actually come to a personal crossroads. My son was five years old when I went through a divorce. At that point, I had a job that I enjoyed. But that got me to just literally sit down and think about what I wanted to do with my life. It was one of those moments.

I actually was just scribbling things on a piece of paper, which later I came to realize as my personal mission statement. I said, I wanted to do something that allowed me enough time with my family and friends, something that facilitated travel, because I love traveling. And something that gave me a career that either helped people or the environment, because those are my foundation. That was my degree coming into the world, because I wanted to do something either for the environment or for people.

As I develop that, I chose careers that would facilitate those. My tenure with J&J, particularly because they allowed so much of fitting with my core mission statement, and similarly with BD, I'm doing what I love. Again, in service of our patients is the number one priority. That was pretty much my why, and I defined it that way.

Mike: That's great. I love to hear the stories of people that are in the industry and really look to serving the patients as the ultimate goal of everything you do. I know J&J. A lot of people think of J&J as baby powder, band aids, but we know it's much more. You were involved in seven different companies at a high leadership level. Tell us a bit more about what drew you to J&J and inspired you to stay for the 20+ years you were there.

Neelu: I think the first move that I made was (again) from UCI to J&J. It was as the environmental engineer. I hadn't really thought too much about like, oh, I'm going to go help patients and study the environment now. You're just going, okay, this is something that fits in with what my next career opportunity needs to be.

As I became more and more involved with my role at ASP—it was my first company—Johnson and Johnson as you know, has a credo. You see it on the walls everywhere. I'd be like, okay, and I'm reading this thing about what our responsibilities were. At the top of it, it's always our responsibility to doctors, patients, and nurses.

As you start living the journey, you realize how important that really is in all your decision-making and who you evolve as a J&J employee. Now with BD, we have the BD way, which is very similar. We do what is right. Again, the focus is on the patient. I think that helps refine how you think and the decisions that you make.

Mike: Definitely. It's kind of crazy. I can almost see the ASP building straight out my office window here. It's right across the freeway. It's neat to tie together some of those points. I wanted to get some thoughts, because being at a company for 20 years, I'm sure there are some different actions that maybe you took along the way to help put yourself in the spot to take on those leadership roles down maybe 5 years, 10 years down the road. How did you take ownership of your own leadership experience at that point?

Neelu: I think when you're early in career, this has happened to me. I was actually at an OCRA event. Do you know when you have the little mixer at the end? I was speaking with a young lady and she said, what's your five-year plan? I said, well, I don't know what I'm doing tomorrow frankly, so five years is way too far. Her response was, well, that's sad, isn't it? I was like, oh, what?

But that got me thinking, because up until that point, I had a job. What that got me shifting my mindset to was, what does a career look like? What decisions do I need to make to advance a career, not just a job? Again, the distinction for me really is you come into work, you do what you're supposed to do that day, and then you go home. That's it.

That's your puddle of information. I'm supposed to give something to Mike. I'm supposed to give something to Courtney. I hand that off, I'm done. Now, a career to me is looking at the bigger picture. What does it mean when I do X? What are the ramifications? And how can I influence those in a positive way?

That's when I started really thinking about how to not just make a decision workwise on money, because everybody's like, oh, well, they're going to pay me a lot more, but it's like, yeah, but is it meaningful? What value are you adding? How am I growing in my role to then (again) give back.

If you look at my career profile, it's peppered with things like career changes—I mentioned going from environmental to Reg Affairs—it was huge. I knew nothing, but I learned. Secondly, having leaders that encouraged me to do things like take stretch assignments in roles that I never would have thought I could do. So having people that empower you and believing in you.

I've also done several lateral moves. People were like, well, but you are a director here. Why are you going as a director to another company? My perspective on that was to look at how much I am learning. It isn't always (again) about the title. It is about what you're learning and what your takeaway is. Going from something that was a 510(k)-only company. Obviously, not assuming everybody knows what these things are.

From an FDA standpoint, they look at devices from a risk-based system. The lower the risk, the lower the classification. Class two medical devices, for example, require documentation called a 510(k), so you need to get a clearance from the FDA. I'd worked in the 510(k) arena for quite a while. The next level, which is class three devices, which are your PMAs, which are novel devices that are coming out into the marketplace, there is nothing similar to that.

Going to that, I did a lateral move. But I got to learn about clustering medical devices. Similarly going from simple hardware devices to understanding software-driven medical devices. Just making those kinds of decisions to see how you become a well-rounded professional, not just seeking a title, I think is one of the ways I've approached my career.

Courtney: What excites you about Regulatory Affairs? I know you've been here for over 25 years in this role. You talked about some career changes. Obviously, I like to make the assumption that you enjoy Regulatory Affairs. What excites you?

Neelu: Honestly, it's interesting because when you tell people you work in Reg Affairs, like you're in some room filled with scrolls and these terrible requirements and regulations. I was supposed to be with really boring people. But honestly, I think it's fascinating because it is about people. That is what I love about Regulatory Affairs.

Yes, you have regulations that you need to meet. You have guidance documents from the FDA, et cetera. Think about what we have to do. They have a job. The agency has a job to protect and ensure the well-being of the public. We work for the industry. I have to work with my counterparts in quality, R&D, marketing, pick the function operations.

How do I translate what the requirements are from an agency standpoint into what we need to do from an industry standpoint? That's the piece that I love. And that's why I've stayed in RA for so long. There's something fascinating about going from feasibility of a device to actually seeing it come on the market.

I've been fortunate in my career to actually go see patients where the devices are being used, that I actually touched from an RA standpoint. Yeah, I think RA is one of the best fields that I could have chosen. I was fortunate to fall into it.

Courtney: That's amazing. I know that RA can definitely be a contentious department within any organization. How do you overcome some of that, maybe adversity that you'd say in your role?

Neelu: There is quite a lot of that. There are actually two things. One is people not wanting to hear what you have to say. Essentially, rather than saying, well, you have to do this, I believe in taking people on the journey.

It's like the more you partner with whichever stakeholder to say, okay, this is why we need to do it, and this is how I'm looking for your expertise on ensuring we meet the requirements that we have, versus saying, you need to do this because the regulation says so. No negotiation at that point. But having the ability to educate people on why you need to do certain things (I think) goes a long way.

The second part is repetition. This is sometimes a little more frustrating than the whole education piece. That is, if people don't like listening to the message, they will ask the same question over and over again expecting a different answer. Or short-term memory. People are like, I don't remember you saying this, and it's like yes about it at the last meeting.

That I think is (again) a journey that we have to take people on. Being a person who models the behavior that I want to see in others, I ensure that I don't go, what do you mean you don't understand? I always need to take it back to the foundation of they're coming from a good place, let's meet them in that place, and help them move forward.

It's not an easy job, but again you don't get into it if it is easy. Again, it takes a certain type of RA person or a certain type of personality to go into regulatory as well. I don't mean just being an extrovert, because clearly I'm an extrovert. But I think it needs somebody who understands, likes people, and likes to take the time to (again) help people understand our universe.

Courtney: I think all of the things you've mentioned really highlight just such excellent teamwork, because you do work cross functionally with so many other groups. Just being an excellent teammate, it sounds like it’s also been key to your success.

Neelu: I think the only people who can say I was an excellent teammate are the people I worked with. The same way. When people say I'm an amazing leader, it's like, no, you cannot say that. It's your people and the people's lives that you touched can say you're an amazing leader. You just do the best that you can.

I think for me, one of the key elements has been whichever organization I went to, we think about Johnson & Johnson as this one big company. It isn't. It's made up of multiple companies, each one with its own culture and its own challenges and successes. Going into every organization, I always thought about, what is the impact or what's the value that I'm bringing?

Now that I'm at BD coming in here, one of the first things that I did was come up with my mission statement. What do we want to be? Secondly, what is the quick description of my RA team? We believe in ACE. Essentially, when we interview people, we're talking about ACE.

Accountability is huge for me. It's not just holding ourselves accountable to the best quality of work and best representation on teams, but it's also holding our counterparts accountable for the quality of their work and the types of interactions we have.

Then collaboration. To your point, it's really easy to have people go, we just don't want to do this. It's like, no, that's not collaborating. Using the word no is the easiest word in the English language, because it shuts off all possibilities. There are points where you do have to say no, but how do you (again) help people understand? Collaboration is the second one for me.

Then education. We've already talked about that. We should never assume everybody has walked a mile in our shoes. How do you help them understand the space and how you guys (again) collaborate to get us to the end goal, which is bringing the safest, most effective medical devices to our patients?

Mike: That's excellent. I wanted to ask you one question to follow-up your earlier comments around going to each of your new positions, knowing that you are going to be learning something new, and having the courage to leave something that you're probably pretty comfortable in and taking that step to maybe another J&J company, another organization, and having to learn something new, which I think could be exciting, could be a little bit nerve-racking, could be something that you're maybe nervous about.

I'm curious how you made those decisions to jump to that next opportunity, even if it was a lateral move. I imagine that you're coming in having to learn something, going into an environment where the experts knew everything about that, and you had to demonstrate your ability to learn and lead in those environments. Tell us about that experience.

Neelu: Yes, it is scary. I think that's the word that we didn't use. It is frightening to go into a new environment. But again, I think coming up to understand that you are bringing something of value to the table. You're not just coming in to say, hey, help me understand and help me lead. It's about, what expertise are you bringing to give to the organization? What value are you bringing?

From a decision standpoint, I had to get comfortable in the unknown. That happened way early when I was given a stretch assignment of going from RA into quality to manage the complaints department, because their manager had exited suddenly. They said, hey, we need an interim. Can you take over quality complaints? And I was like, I don't know anything about this. Again, it goes to that manager's faith and that ability to go, you know what? You'll be fine.

I came in. There were (I think) five or six people in the team, and they were looking at me like, you know nothing about our world. And I owned it. I do this at every company that I go to. I don't understand your devices yet. I don't know the culture yet, but understand that I know regulatory affairs. I've been doing it for a really long time. Help me learn so I can help advise as quickly as I can.

With my complaints organization, I had a candid conversation with the team. I said, look, I don't know anything about complaints. You guys are the subject matter experts. Now tell me what your challenges have been and how I can best help you.

By having that conversation, one of the earliest things I found out about that poor group was that they had never had product training. They weren't processing complaints without actually having seen the devices or understanding how they're used.

The first thing I did was I had our technical service group have us over into their area, and they walked us through everything. Did I add huge value? Probably not, but at least we're able to touch and feel the devices that they were working on complaints on.

Another person said she'd always wanted to get into presentations, so I had her create a couple of presentations to our stakeholders. It turns out, she did a beautiful job. The next time I was asked to present something, I said, would you like to go ahead and do that?

She and I practiced. I set her up for success and made sure I was there to help if she needed it. But again, she did a beautiful job. Did I directly impact the complaints process? Not really. But what I did was I continued to engage the team and help them grow in whatever it was that they needed.

I think going into any role to circle back to your actual question, I think it's having confidence in knowing that you do bring something of value. You're not just coming in to be a sponge and learn. You're also contributing something.

Again, from a collaboration standpoint, I've had people say, oh, but you've never worked in the space of this before. I'm like, you're right, I haven't, but I do know FDA and class two devices or class three devices. Pick something. I have worked in software for years. And that's when people go, okay.

One other big piece of information that I learned was, at some point, you need to stop auditioning for your job. When you get a new role, you get that because people saw merit in your capabilities, they believe you can add something of value to the organization and steer it. If you're a people leader, they'll check that out as well. You don't need to continue auditioning for it because once you have it, lead into it, lean into it.

Mike: That's great. I particularly like the part of your story, where you didn't come in and know all about the complaint process, but you helped uncover how you could help the rest of the team get better at what they're already good at, by giving them knowledge about their products that they're fielding complaints on and just by asking questions, I'm presuming .

Neelu: That's what you have to do. You have to have those learner questions. Did I come up to speed on the process? Absolutely. Within my first 30 days, I knew exactly what the process needed to be. At that point, we started working with another company.

I actually created a complaints process that included two different businesses. It's giving yourself time to ramp up on the technical knowledge that you may need about that particular function while you're adding value in some way.

Courtney: It sounds like you've done a lot of creating opportunities, too, that was not there before for your folks. I think that's exemplary leadership and amazing to hear.

Neelu: Thank you. It's because I've had amazing mentors in my life. This is interesting because I think when we talk about mentorship—I know we haven't gotten there—I've had informal mentors, because people always say, okay, do you have a formal mentoring program?

Going through my career, there was no formal mentoring anything, but I did have people who navigated me or coached me to take risks where I normally wouldn't have done, because they had faith in my ability. I think as a people manager, that's what we need to look at. How do we help people recognize their capabilities when they themselves may not?

Mike: That's great. In prep for our interview here, I looked at some of the recommendations that you've received from others. Overwhelmingly, those individuals highlighted how you worked as an outstanding coach and mentor to them. Getting into this mentorship topic, I think, like you said, it's important to find mentors. Maybe if you could continue talking about some of the key mentors in your career that helped you on that journey, that would be great for us to hear.

Neelu: The first one I would say would be the gentleman who got me into Reg Affairs from environmental. He was phenomenal, because it's one thing to say, okay, take a job in my role, which I did. But he always had me thinking, because I used to go straight to him and say, hey, John. The team is asking this. What should I tell them? He was like, well, what do you think you should tell them? I'm like, I don't know, hence me having this conversation with you.

Then he would say, hey, why don't you go read this guidance document, and then let's come back and have a discussion? Then I would read and come back. I think, Courtney, when you teach a person to fish, talk, right?

Courtney: Yeah.

Neelu: There were times when I would just say, I don't know, John, can you just tell me? He'd be like, if you teach a man to fish, you feed him for a day. I'd be like, oh my gosh, I should be a baker at this point. He was amazing at getting me to think and not just give answers.

As leaders, often we are so busy. When somebody comes in, it's really easy to say, just go do this. It's actually a mindful thing where you have to pause and go, let's get them to think about it.

Another one was a senior leader within J&J. She was awesome at creating opportunities for me to participate in not just cross business but cross sector opportunities.

As you know, J&J has three sectors. You got medical, farm, and what's the other one? See? You leave in two years, you forget. There was one, I was asked to join a pharmaceutical group discussion in creating a process. I said, I know nothing about farm. Her comment was, yes, but you know medical devices, and they don't understand our space.

That was pretty profound, so I joined. I provided the direction. I was the one who ended up presenting to senior leadership at J&J for that particular topic. Having those kinds of folks who help you along the journey (I think) is phenomenal. Again, they were not my formal coaches or assigned.

I'll give you one other interesting anecdote. At least, I think it was interesting. There was this one event that I was invited to discuss leadership and mentoring. Actually, it was also networking. At the end of the conversation, this young lady who was sitting at the back of the room, as I was walking out, she says, can I ask you something? I was like, yeah, absolutely. She said, will you be my mentor? I said, okay.

I said, so what are you looking for? She goes, I want to be like you, the way you talk, and you're very animated. I said, okay, you can't teach somebody to be a personality. I did set up time with her. We spent 30 minutes. She was a total introvert, but I helped her understand that you know what? It's okay. You don't have to be as animated as I am to do anything. Be 100% you.

We talked about authentic leadership. Be yourself, but also know what it is you want to accomplish, and what are the areas that you need to grow in both from a technical standpoint but a leadership standpoint as well.

I think that that mentorship, there's mentoring, there's coaching, there's having an advocate. I don't know how often or how many people know the difference between those. I know early in my career, I didn't know, because it's one of those crazy things that nobody really talks about.

Mike: It's very true.

Hey, Courtney. A lot of our clients we work with have great ideas on how to improve their business, but they just run into challenges that seem to get in the way of accomplishing their goals. Have you ever seen that?

Courtney: Yeah, of course. It happens all the time. I've seen clients struggle with a lack of visibility into all the work that's happening within their organization. I've seen clients that are focused on manual tasks, which takes away from focusing on the actual project work. And I've seen leadership struggle to make decisions due to lack of timely information.

Mike: That's so true. It seems like just knowing the problems to fix is only half the battle. How do you help your clients address those challenges?

Courtney: We of course, first work with our client to design a structured management process that fits their culture and team. In a lot of situations, we bring in tools like Smartsheet to help the entire project team be more efficient. With the help of Smartsheet, we were able to create dashboards, automate routine tasks, and have the information ready in real time to help support leadership's decision making.

Mike: Wow, it sounds like you not only execute on the project, but your work helps everyone get more done with less work.

Courtney: I hope so. Smartsheet is a powerful tool, and my clients seem to be really happy with it.

Mike: That's great. Now, if somebody needs help on their project, what should they do?

Courtney: They should check out enterey.com and schedule a call with us to see how we can help.

Mike: Sounds like a great idea.

Courtney: Thank you.

Mike: I was going to go next to just thinking about working within the large company environment. J&J is a very big company. But really the impression I get is, as you describe, a collection of smaller companies forming one very large company. I'm not sure BD is similar or is much more of a large-large company.

Neelu: It's the same thing.

Mike: The same thing, yeah. My question is really thinking about your advice to people that are in large companies, whether it's BD, J&J, or any other big pharma, or whatever company for that matter. How would you advise people to take ownership to progress in their career?

You can easily get, I don't want to say lost in a big company like that, but you can. For those that are eager and want to move forward that don't get that advice that you got that one day when they said, hey, what's your five-year plan, how would you tell people to take that next step?

Neelu: Although these companies are massive, one of the things people need to recognize is we come into a role. You go into a business unit. The first thing really is understanding where you want to go. I think there's a proverb or something, which I'm going to horribly massacre. But if you don't know where you're going, you will get there.

Essentially, you need to have an idea. Now, when I ask people in my own organization, what do you want to do? Where do you see yourself? It doesn't become a finite thing. Once they tell me, hey, I would love to work in, I don't know, pick something, labeling. That doesn't mean that I have now pigeonholed them into labeling for the rest of their lives. That is something that can change. But you need to be able to have an idea of what you want to do.

Again, the next 3–5 years, where do you think? But have that conversation with your manager, because they may (again) see the positives that you might not. They might say, hey, this is a better direction for you, let's have the conversation.

I've also been in conversations with one young lady who comes to mind, where she said, I've done this, I've finished this, I need to learn, I think the company should allow me to do X.

She talked for about 15 minutes about all the stuff that she needed and what she wanted to do. When she paused for breath, I said, let me ask one question. What are you doing for the company? What contribution have you made to a process, a person, anything? She has to just pause and think about that.

As people look to grow in their career, it's symbiotic. When you are doing your role, what are you doing exceptionally well? What is it that somebody will go, hey, if I could work on this with Fred, I would love to do that, even if Fred is in a different role? What are you doing to be known across the organization? Also, having those stretch assignments. But have those conversations. That's how it first begins.

Do your job and do it exceptionally well, because again, a lot of times, you will come across people who think they are doing a phenomenal job, don't have the conversation with their managers who are going, yeah, your average at best, but there's that disconnect. That's when people end up leaving an organization. It's always sad, because you need to have the discussion.

The manager knows what your expectations are. We can work with each individual to create development plans if they want to work across organizations and they're doing a phenomenal job. Absolutely, that will get facilitated.

When I first went to J&J, I remember going to the east coast for my first big conference of some kind. I think I might have been a manager at the time. Everybody seemed to know everybody, and I was in this room going, I know nobody.

I've made a few introductions. By the way, I’m really terrible at networking events, believe it or not. So I had a few conversations. Fast forward about 5–7 years, I was at an event. There were some announcements. They were like, oh, and Neelu is here. Well, of course, everybody knows Neelu.

Going from a moment where I felt I had no idea who these people were, to now having enough not just exposure but actual actionable work that I had done that people were like, oh, yeah, if we need this, we can go to Neelu. Does that help a little bit?

Mike: Yeah.

Courtney: Yeah. I got to say, Neelu, I have a mutual friend of ours on LinkedIn who works at Johnson & Johnson, who's a personal friend of mine. I said to her like, oh, I got to meet Neelu. She goes, everybody knows Neelu. She said the same thing about you. I guess what you are doing is highly effective.

Neelu. Thank you.

Courtney: You're welcome. It was in a very positive way.

Mike: I think your words are very good in terms of taking action, to demonstrate your value to an organization, to others. It makes so much more of an impact than just trying to tell people hey, this is what I can do. So doing it and then being that person that everybody wants to go to, because they know that you've done it, you can do it again, and you'll help.

If you need some help with something unique or innovative, I'm going to go to the person that demonstrated that innovation in some other way before. How can I draw on that person's experience and fearless attitude to go take on some new challenge? I love that approach.

Neelu: I think part of it is the what and the how. At J&J, we talked about that. At BD, we say the same thing. It's like, what do you do, but how do you accomplish it? There are people that are like, oh, yeah, I got this done. And all of the team is like, I will never work with that person if I can help it. That's not where you want to be.

This was me. Early in my career, I used to think, well, if I do a great job, my boss will create my development for me. Then you become a manager and you realize you've got so many things you have to do and so many people. You need to take ownership of your own development plan.

You need to have that conversation with your manager to create it together. But if we sit back and just wait for people to recognize us or create a development for us, that is something that I think we should stop doing. We need to just have the conversation, and it's not an easy conversation.

Another question is like, well, I've been at a job for three months, do I talk to my boss about what my next move is going to be? It's like, well, three months, you're just starting to learn. Think about what your contributions have been. You can have that initial conversation.

But if you go into a role—this is what I say to folks who are applying for the jobs that I have open—come in for the job that is advertised. Don't come in for a job that doesn't exist. Come in and execute excellently. Let's add, it's a non proposition and let's talk about your development plan. And let's execute against that development plan.

Mike: That's great advice. We got to get done what's on our plate today, and then prove that we can take that next step Very good.

Now, let's shift to the flip side. Are there leaders in your career that you worked for or around that maybe you didn't agree with, and you had trouble navigating? Imagine there may be some.

I want to hear some of your advice. How do you navigate the situations when maybe you're not on the same page with your leaders or others in your group. To still be able to contribute and bring your best, how do you do that in a situation where it's not all going great?

Neelu: It isn't. Honestly, that's a great question because sometimes when you hear podcasts or when you hear it's the sunshine and roses, it's like, yeah, [...]. But no, I think I have probably learned more from my not-so-great managers than I have from my great managers.

What that makes you realize is, this is something I will never do to my team. When you talk about specification, this is a low end of my spec. I will never do this, but have aspirational things. It's like, I would love to be like X.

One great example in the cubicle world early days, my manager’s office was almost at the door that you went home. It didn't matter what time you were leaving. It didn't matter. It could be 5:00, it could be 8:00 PM. If he said, goodnight. The first thing he would do is look at his watch. Look at his watch, good night.

Every night I went home, I was like, oh, my gosh, did I not stay long enough? And this went on for years, and it just drove me batty. Once I asked him, I said, did you know that you look at your watch when people walk? He goes, Yeah, It's just something I do. That reinforced what I thought.

One of the philosophies I have is, you know what? Do your job, do it excellently. I don't necessarily need to know if you're coming in at 8:00 or if you're coming in at 9:00, whatever it is. Just get it done. None of my team feel—at least nobody's told me—that is something that's a constraint for them. There's something simple such as that.

Another one is being empowered to act and execute against your plans. I had one leader who within my first 60 days of 90, I had some great proposals that were vetted with my peers and all the rest of it. I just couldn't get them done, because it was like, well, give it another… Well, that's right. That was frustrating as heck. I had to have a candid conversation with her as well to say, if we don't execute, then we're perpetuating something that really needs to change.

Now, did that change? Not really. So I had to make a difficult decision as to how effective I was going to be within that role and whether I needed to make a change. It's not always your manager who needs to change. Sometimes you need to understand the environment you're in and whether you can sustain being in that organization.

Mike: That makes sense. I love the example of the person checking his watch each day, because there are two ways to look at it. It's just something that I do. It's the response you got, but it makes you realize that some very simple action or activity that you do can be very impactful to somebody who you may not realize it.

Maybe it doesn't seem that big of a deal to you, but perhaps to others, and it's the impression that you're leaving. That's a great example of how things are. It's not really anything he said or it's just an action that he took that was unspoken, and that made you wonder.

Neelu: Exactly. But interestingly enough, I did talk to him about it. He said, yeah. He's reinforcing. That was an opportunity for him to go, oh, I didn't even realize I made this—

Mike: Right, that's true.

Neelu: I also had another leader. This was actually a senior leader who came into one of the companies. One of the first things he said is, yeah, my wife says, I'm a really difficult person to discuss things with, but she's gotten used to it. All of us in the room were like, okay. What is that saying?

I think at a certain point, you have to be really mindful and deliberate about what you're saying. Again, I go back to my statement about modeling the behavior you want to see in others. I've been in situations where people are being very ornery—I love that word—and argumentative.

Now, I can absolutely argue back, but is that what I want to do? Is that the behavior that I want to reinforce? And the answer is no. I will defuse the situation. Whereas the first reaction would be like, listen, but no. That's not what I'm going to do.

Mike: That's great. What that reminds me of is—continuing with the theme of lifelong learning—that individual, somebody got used to his behavior versus him learning how to evolve and become better. Along those lines, you talk about moving from one position to another where you're forced to learn. Even if staying in a position, how do you go about learning just maybe beyond the job? I want to become better at whatever skill that might be. What's your thought there?

Neelu: Again, it's a discussion that you have with your manager. I was actually faced with the same situation in a role that I'd been in for about two to three years. I knew what I was doing. I could pretty much do it. The project teams knew me, and I wanted to have that stretch.

Now, it wasn't necessarily a stretch assignment. I had the discussion, because my leader at the time had health economics and reimbursement, reg affairs, and quality. I'd already done my stint in quality, so I had a discussion with her about, you know what, I would love to do something in health economics and reimbursement. Why? Because once a medical device is cleared before a hospital can use it, there's all of that stuff that needs to happen, which is the whole reimbursement environment which I knew nothing about.

I was facilitated to join that team for a very specific project. That was to understand the reimbursement environment across a particular segment of healthcare, essentially. If I hadn't asked, it would not necessarily have been offered to me. But by putting it out there to say, I would love to learn about X.

I actually had short-, mid-, and long-term goals. It was just a pretty short assignment, but I aligned us to what the deliverable was going to be and executed against it. The department got a deliverable done that they didn't have time to do themselves. I learned a ton from that, and I was able to bring that experience forward.

Essentially, did I need to do it? Not really. But at that point, if you had my resume that said, RA with reimbursement and health economic experience versus somebody with just pure RA experience, I would definitely have had that leg up.

Mike: You helped to basically put more tools in your toolbox than when you went for something even different from what you just learned. Now, you've got more value because you've got something else you're carrying in your back pocket to help understand the new business unit.

Neelu: It's that, but also what you're doing broadens your perspective. I think that's why I've done several laterals, et cetera, because speaking just purely from a regulatory lens is one aspect, but knowing enough about other functions and other areas that are adjacencies gives you that broader perspective.

Being part of leadership teams, I don't just speak for RA. I am responsible for the business perspective as well. I'm not saying it's not enough to know RA. It is absolutely enough. But if you are somebody who wants to continue to learn and grow, then why not learn about something outside of your immediate sphere?

Mike: That makes a lot of sense. Excellent.

I really appreciate all your time. We are coming towards the end of our time here. I always like to give our guests the opportunity to highlight anything else you might want to share that excites you today, whether it's in the business world or not, maybe something that you're working on that you want to share with our listeners. Anything that you'd like to share beyond the business world, so to speak?

Neelu: I think the only thing that I would say is don't be afraid. Take risks, but take known risks. Assess, decide that you're going to do something different. Weigh the pros and cons. Don't be afraid to have that conversation with a mentor or somebody that you trust within the organization or outside. It's (again) really easy to cut off possibilities rather than just take a leap of faith and make an informed decision. But take that leap. It might be fun.

Mike: That's excellent. Just to add to that, I often think back to, and I don't remember the exact details of where I heard this, but talking about a conversation you might have with a manager, a peer, or somebody. If it's a difficult conversation, it is going to be difficult. But looking at it as, hey, this is going to be 5–10 minutes of potential pain, but I'm going to get a lot of reward beyond it.

I've got to encounter that pain in order to get to the next step, and get to the next level and beyond, and not be afraid of having that experience, but anticipate it, deal with it, and learn from it. It's very much aligned.

Excellent. Thank you so much, Neelu. We really enjoyed having you on the show. We're looking forward to hearing more great things that you're doing at BD and beyond.

Neelu: Cool. Thank you so much for having me. Lovely to speak with you both.

Mike: Yeah, very good.

Courtney: Thank you so much, Neelu. I just want to say that I am delighted to talk to you on a Monday morning, because you don't know how much more fired up I am now for the rest of the week that I've got the chance to talk with you. Thank you for this wonderful conversation and all the inspiration, truly.

Valerie Brown is the Senior Vice President of Global Quality Assurance at Gilead Sciences. Hear her insights regarding science, the pharma industry, and what its like to work in a regulated field.

Listen to the episode to learn more about Valerie, her career journey, and her advice for being successful in your own career. 

• Valerie's career journey and her advice for your success
• Her mentors and why they were important
• Advice for motivating your team
• How to learn from your mistakes
• Characteristics that Valerie admires in other leaders
• Key takeaways from Valerie’s interview
  

Mike: I'm really excited today to have Valerie Brown on our show. Valerie is the Senior Vice President of Quality Assurance in pharmaceutical development and manufacturing at Gilead Sciences. She leads a global team that is responsible for quality and compliance oversight of contract manufacturers producing active pharmaceutical ingredients, drug product intermediates, oral solid dosage forms, parenterals, biologics, and medical devices. Pretty much everything, right Valerie? For worldwide development and commercial markets.

She joined Gilead in 2010 as a director of commercial API quality. Valerie was promoted to Senior Director of Quality in 2013, responsible for all commercial products, including APIs, finished dosage forms, and devices. She was promoted to Vice President of Quality in 2018, and in 2020 Valerie was elevated to her current role as a Senior Vice President of Global Quality Assurance.

Prior to joining Gilead, Valerie was the Global Director of Quality and Regulatory for Zach Systems and PPG Industries. She is a member of the Parenteral Drug Association and the International Society of Pharmaceutical Engineering. Valerie holds an undergraduate degree in biology and chemistry and a graduate degree in healthcare management. Please join me in welcoming Valerie Brown to the show. Welcome, Valerie.

Valerie: Thank you so much, Mike. Thanks for that intro. It was really great to hear about the animal menagerie with Josie and Courtney. That's fantastic. I don't have any pets, so I can't relate to that, but that's great.

Mike: We've got a few that we could loan you if you need one.

Courtney: I was just saying. If someone comes, rescue my cat from me.

Josie: I have three in the bathroom ready for a home.

Valerie: I'm good.

Mike: I'm with you, Valerie. I'm with you. Valerie, let's get it started. Tell us a little bit of background. How did you get to the point in your career where you're heading quality for Gilead?

Valerie: I started my career in the laboratory. I've always been very interested in the sciences. I'm more (I guess) maybe a science geek, if you will. I started in the lab. I always wanted to be in the lab. I wanted to move into manufacturing because I always want to be able to make things. It's very interesting in synthesis and formulations.

My first job was in a laboratory. We were doing a lot of analysis for pharmaceuticals, as well as with the National Institutes of Health, with Walter Reed Hospital and George Washington Hospital. I was in the Washington, DC area at the time.

Since we were a laboratory doing some diagnostic testing for pharma companies, we were subjected to FDA inspections. As a person right out of undergrad, I don't know anything about the FDA. I heard of them. I had interactions with our quality unit, which wasn't very pleasant many times, but they asked me to be the scribe for the inspection. I said, oh, scribe, that means I just have to write things down. They said, oh, yeah, that's it.

The day of the inspection, when the investigators arrived, a young lady who was going to host the inspection became very ill. The department head said, okay, kids. You're up. I was like, what are you talking about? What do I need to do? That was my trial by fire. That was my first foray into hosting an inspection and understanding how to look under the hood in terms of some of the quality and compliance areas and deficiencies.

We did get a 483. We responded. Of course, that became my responsibility. And then I got a really good view in terms of what folly really does. You're not the police, you really have to partner with folks.

I continued my career in the laboratory, and then I was recruited to a small pharmaceutical company in Pennsylvania. After that, I was recruited to a contract manufacturing organization in Texas, which is like a planet of its own. It's like a whole nother country. It was nice. I got a lot of experience. They had a plan in France. I spent several years there working with that facility, as well as the one in Texas.

In France is when I met the Gilead team, because some of their key products that they had very early on were being manufactured by our facility. We did a lot of fine chemical manufacturing, which is APIs for large pharma companies. And then Gilead, after that, started calling me about every year a few times, asking me if I wanted to join their company.

At that time, I just moved from Pennsylvania, where it was cold, ice, and snow, and I moved to Houston, Texas. Even though I spent a lot of time in France, it was no snow, no winter. I was like, no, and the cost of living was certainly a lot less than in California.

I didn't do that. But then the organization went under some business turnovers in terms of moving with PPG than we were at Zach Systems. In Zach Systems, they decided that they didn't really want to do business in the States. They asked me to become a consultant. I traveled back and forth between France, Italy, and the US.

At that same time, Gilead called again and said, hey, what are you doing? Why don't you come and think about joining us? So I did in 2010. It's been a great, great journey. I knew a little bit about the company. At that time, I was very impressed with their passion, with the innovation that they do in terms of drugs.

It was really great. It's really good to be a part of all of that, and then they get to see it in action on a day to day basis. That's how I ended up here. My first role, as you said, was managing commercial APIs. I'm looking at all the outsourced APIs that went into our formulated products.

Mike: That's awesome. That's a great story. I didn't realize all the connections there, but that's quite the path, especially with the international experience and to think that you met the Gilead team in a whole other country.

Valerie: Exactly. Yeah, it's very interesting.

Mike: Pretty fun. What was it like? Because PPG is more chemicals-focused, is that right? What was it like going from the chemicals-focused to the pharma-focused?

Valerie: It's like you're really on the other side of the table. PPG is Pittsburgh Plate Glass. PPG decided that they really want it to be like a premier coating company, and really didn't want to be totally involved in [...] with pharmaceuticals, because it takes a while to get pharmaceuticals to market.

If you're building a plant to make [...], you turn the last screw on the vessel and you're making money. That's not the way it is in pharmaceuticals. You have clinical phases you go through, you're developing your product, and it can take years to come to market.

It was a little bit different. You're still working with a lot of pharma companies as a contract manufacturer to help them with whatever phase that they're in, whether they're in the IND phase and phase one, phase two, going towards commercialization in an NDA or BLA filing. It's a little bit different. It's like being on the other side of the table.

People think of pharma, and pharma has deep pockets. Beyond the CMO side, you have razor thin margins. Every gram of product counts. It was a good experience. It was good to be able to see how you can have many, many customers.

Of course, like I said, a lot of big pharma customers, everybody wants something different, but you have to understand and make them understand that I have to follow regulations. Even if he wants something different for your product, you really aren't that different. You have to follow them all.

Mike: That's great. I love that analogy. As a CMO, you're serving multiple different companies. You got to accommodate all your different requests. Now you're on the other side. You're one large company working presumably with multiple CMOs out there. You're trying to navigate the opposite side of that. Did that prepare you for coming into your role now where you have to manage the requirements or the other direction?

Valerie: It did. I got a little bit of that when I worked for a small biotech biopharma in Pennsylvania. You really come to the realization that it has to be a partnership. It's not like, here's my process, bring me back a product. You really have to partner with the CMO in order to work together to bring that product to market.

It definitely has to be a partnership, one built on trust and certainly the support, and basically share decision-making. But in the end, of course, as a labeler or the person who's responsible, the sponsor company is responsible, but you definitely want to have that partnership. If not, it's not a very good working relationship.

Mike: It makes sense. I'll shift gears a little bit and maybe ask you about, as you progress through this, clearly it sounds like Gilead had an eye on the counter for a little while. But along the way, there are probably a lot of people that you interface with, that you saw as leaders, that you maybe either were mentored by or you sought to emulate in your career. Does anybody stand out that you would say, hey, this is somebody that helped me in my journey?

Valerie: Oh, absolutely. There were a few people. On the personal side, I would say my grandmother. My grandmother was definitely someone who had some very keen, very strong leadership qualities. She had 12 kids, a lot of grandkids, a husband, and lots of siblings. She's really just the powerhouse or the force of the family.

In high school, I had a high school science teacher who just was very instrumental in helping me see. He made everything really inspiring. Science can be boring to some people, but he was one of those individuals who was really encouraging and giving you the freedom to think outside the box in terms of some of the experiments that we were doing.

In the business world, like I said, I come right out of undergrad working in a laboratory. They usually pair you with someone to help train you and onboard you. They paired me up with what they considered was the grouchiest, meanest person that they had in the lab. He was an older gentleman. I'm just a bright-eyed person who's ready to work and ready to do whatever.

The first few encounters were like, whoa, but he taught me a lot of things, like not to trust but verify, because he always says this saying that I saw in a book years later that says in God we trust. For all others bring data. That was his mantra.

But he was also someone who motivated the team. He motivated people to get in line with what the vision was, what the goals are, and making sure that we were all aligned with that. I saw that as something really powerful.

These weren't people that reported him. This was just the way that he projected his persona. It was like, here's what our goals are. He would inspire and motivate us to say, okay, yes, this is what we need to do.

I learned that leadership is not so much about trying to tell people what to do, but it is being able to communicate thoroughly what needs to be done, how we can do it, why we're doing it, and then that of itself inspires and motivates people to get in line with it. I'm sure wherever he is now, he's probably still really grouchy.

Mike: Yeah, probably so.

Courtney: I've noticed you had a rather rapid ascension through Gilead from the time you started there. I was wondering, from somebody who's a bit earlier in their career, what characteristics would you attribute to that, and how did you do it?

Valerie: It's funny you say that because it didn't seem rapid to me, but okay. One of the things I would say is just learn as much as you can. Not just to stay in your own little area, but to learn about what all the other functions are doing. How does what you do impact on that?

When I say that, I worked within pharmaceutical development and manufacturing, and that's a huge organization in and of itself. It's 20% of Gilead today, but there are also other functions. You've got regulatory, you have legal, you have medical affairs, even development ops, and plan ops. All of that human resources and project management. Just a myriad of things in the pharma world, and just being able to talk to people and learn about what they're doing, understanding how I can be more impactful in terms of what they're doing, and then understanding that whatever I do may impact what happens as an outcome.

I would encourage people to always just be curious. Be intellectually curious in terms of what you're doing in your role, and then just to venture out. Raise your hand for those special projects. Even if it’s not something within your wheelhouse, do something different. Just be able to [...]. Just gain more skill sets in, put more tools in your toolkit.

It may not manifest itself into you moving up the ladder, but it definitely gives you more breadth, depth of experience, knowledge, and definitely gives you a little bit more insight in terms of, what do I want to do?

When I joined Gilead as the director for commercial APIs, that in and of itself is a huge job. We have several contractors globally that are manufacturing active pharmaceutical ingredients for us. You've got to provide quality oversight for them. They have inspections. You're helping them prep for inspections. You're helping them with the responses. And then I was really curious, how does this all start?

It starts with discovery, that the molecule coming from discovery to development is it develops through our process, but then it goes into a final dosage form, whether it's a pill or tablet. That becomes much more fascinating. And then you understand the other clinical aspects. These are drugs that are being tried in clinical trials with people, getting those readouts and things like that, and then there are lots of conferences that are held for different therapeutic areas like neurology, information, oncology. Just having that intellectual curiosity I think is key.

Courtney: That makes a lot of sense, because I was also going to ask you about the educational opportunities that you found along the way. It seems like volunteering for the extra project and as you mentioned, being able to step out of the box or step out of your comfort zone, I should say, has been really pivotal in your success.

Valerie: I always like to say, Courtney, get comfortable with being uncomfortable. In fact, that was something my first mentor had said to me, because like I said, he was a legend. I just told him one day, you're really making me uncomfortable. He said, get used to it.

Courtney: That's awesome.

Mike: That's great. Just to carry that theme a little bit further, I know at Gilead, obviously, your organization is probably quite large. You have to rely on a lot of people to succeed overall. What's your thought in terms of from the most junior employee to the most senior? How do you get the best out of them in terms of letting them know what their contribution is?

Valerie: A few years ago, we got a new CEO, Dan O'Day. One of the things that Dan said in his first communication to the organization was, "Every employee deserves a great leader." He's a great manager, he's a great supervisor, and he's a great leader. And I take that to heart.

The other thing too in terms of being able to get [...] throughout the organization, we're all leaders. We all lead from where we are. It doesn't matter what your level is, whether you're a very junior person or very senior person, we're all leaders.

We have an obligation to do things like listen actively, explaining the why. It's not so much giving people direction, but always telling them why they're doing that. And certainly making time for people to voice their opinion and provide them a psychologically safe space to do so.

That's one of the things that I always want to impart within my organization, and the leaders in my organization certainly do. Like I said, everyone's a leader. We're all leaders, but we all have that obligation. I think that's what gives people some of the will. Especially the more junior staff who may be a little bit more intimidated in terms of speaking up or speaking out loud. But if you give them that space, and believe me, I get challenged all the time by folks.

The title doesn't matter. None of that matters. We're all people, and I think we all learn that way. Giving people that freedom to certainly, first of all, bring your authentic self to work, but also be able to challenge the status quo. Why are we doing it this way? Or I've seen it done another way or I have another idea, and we always want to encourage that.

Mike: That's great. I'm getting so many great nuggets from you, Valerie. I really appreciate all your insights here. I think some of the things that you learned along the way, and just hearing it from others, and even your thoughts from the comments from Daniel, which are just great insights into how Gilead as an organization is run, how you run your organization. I think it's great to see.

Did you take any of those cues from people along the way, perhaps elsewhere, early in your career that you saw a way that you didn't want to run your organization? For example, like, hey, somebody did this, I'm not doing that.

Valerie: When we talk about leaders and leadership, there are a lot of things that come to mind. Like I said, for me it is to be more inspiring, communicative, and certainly motivating. I've seen more leaders are more authoritarians. When I say that, I've seen leaders that are really like dictators. They just tell people what they need to do, and people follow them out of fear. Not because they are good leaders, it's because they feel like they have to.

That's something that I always say that I didn't want to do. I don't want my name weaponized. I don't want me to be weaponized. If I don't do this, she's going to get rid of me or whatever. I just want people to feel (like I say) the freedom that they can speak up, that they can share their opinions, can share their ideas, and then be motivated and inspired by the goals.

That's my job to be able to communicate it thoroughly, to communicate what are we going to do, why are we going to do it, and then how are we going to do it and do that together? I can't just make the decisions. If you give people the option to certainly weigh in, you get more buy-in, and they're going to be more apt to follow that lead. I think that's one of the things I've seen over the years with leaders is that they strike a fear in folks. That's not that's not leadership

Josie: There was a thing about being a boss versus being a leader. Being a leader, you're part of the team. Whereas the boss, you are separating yourself from your actual team.

Valerie: You're absolutely right, Josie. That's a very good way to put it. Anybody can be a boss. I have a 15-year-old. She's the boss of me. But to be a leader, it takes some humbling. You always want to try to be in the service of others. I'm here to help you, I'm here to serve. I'm not here to just dictate what to do.

Mike: I got a 15-year-old as well.

Valerie: They're fun, aren't they?

Mike: They are a lot of fun. But yeah, they are a lot of work.

Valerie: Oh, no. I might come and get the cat and trade you, Courtney.

Courtney: No. I have to respectfully decline, because I was a 15-year-old.

Valerie: I know.

Courtney: I admire you guys as parents, because it takes good parents to raise good people.

Mike: Hey, Courtney. A lot of our clients we work with have great ideas on how to improve their business, but they just run into challenges that seem to get in the way of accomplishing their goals. Have you ever seen that?

Courtney: Yeah, of course. It happens all the time. I've seen clients struggle with a lack of visibility into all the work that's happening within their organization. I've seen clients that are focused on manual tasks, which takes away from focusing on the actual project work. And I've seen leadership struggle to make decisions due to lack of timely information.

Mike: That's so true. It seems like just knowing the problems to fix is only half the battle. How do you help your clients address those challenges?

Courtney: We of course, first work with our client to design a structured management process that fits their culture and team. In a lot of situations, we bring in tools like Smartsheet to help the entire project team be more efficient.

With the help of Smartsheet, we were able to create dashboards, automate routine tasks, and have the information ready in real time to help support leadership's decision making.

Mike: Wow, it sounds like you not only execute on the project, but your work helps everyone get more done with less work.

Courtney: I hope so. Smartsheet is a powerful tool, and my clients seem to be really happy with it.

Mike: That's great. Now, if somebody needs help on their project, what should they do?

Courtney: They should check out enterey.com and schedule a call with us to see how we can help.

Mike: Sounds like a great idea.

Courtney: Thank you.

You touched on something, Valerie, a little bit earlier about psychological safety in meetings and being able to speak up. What advice would you give to somebody who may have made a mistake at work? Because mistakes are critical in the pharmaceutical industry, but also responding to them is equally as important. What advice would you give to somebody who may not have done something perfectly?

Valerie: I think that's the one thing a lot of us in the industry get tripped up on. I always call it perfection over excellence. I would rather you be excellent at what you do instead of trying to strive for perfectionism. If you make a mistake, you own up to the mistake and let's learn from it. What did we learn from this? How do we move forward?

You focus on the issue—whatever that was—not on the person. I think that you really want to try to separate that from the individual. You're right. In the pharma industry, yeah, mistakes are going to be made. That's how we learn. If you don't make a mistake, I don't think you're trying. You're not trying very hard, but you want people to know that the world is not going to end because you made a mistake.

Let's just pick ourselves up, dissect it, and understand, where do we go from here? What do we do to move forward? But then also learn from it so that we don't repeat it. Like I said, that's the whole nature of how everything's done. Many of the great innovations and inventions came from mistakes that people made, eventually, thousands and thousands until they got to where they needed to be.

Courtney: Thank you. I think it's good to keep in mind the continuous improvement spirit and that's where mistakes play their role. You can't continuously improve if there's nothing that you notice needs to be improved. That's great advice.

Valerie: Absolutely. One thing I always say, because we do a lot of outsourcing, and we visit a lot of contract manufacturers, if I visit a site and they say, oh, we have 0% deviation, that's a huge red flag for me. There's no way, because that means that you're looking at something in a very perfectionist way. Even though the regulators look at that, too. It's like if they come in and you say, well, no, we didn't have any deviations, or no, we didn't make any changes, you're right. That's a huge red flag for anyone.

Mike: That's great. I love to hear the thought that you don't necessarily try to make mistakes, but mistakes happen. We try to learn from them and don't repeat them. I love that context and applying that to a situation.

I want to make one side note. My 15-year-old daughter, she's amazing. I want to make sure I put that plug in if one day she does listen to this.

Valerie: I have a 15-year-old daughter, too. I doubt if she will ever listen to this, but she's amazing as well.

Mike: She's done way more in her life than I think I accomplished anywhere near that age in my life.

Valerie: It's amazing, isn't it, Mike? They have so much more at their fingertips than we do.

Mike: Yeah. Just the drive and motivation that I see from her is just truly unbelievable. Sorry for the little detour. Getting back to it. One question I've always wondered is, Gilead is a very big company, a very big organization, global, products around the world, products that help people in all corners of the globe. How do you keep that all in context? There's a lot going on. How do you manage all that?

Valerie: There is a lot going on. There's always a lot going on. You're absolutely right. It's very humbling, too, to know. When you're in the throes of it, where you're manufacturing products, you're in an inspection, or you're conferring with someone in another part of the organization about an issue, it doesn't dawn on you how huge this is.

We have many testimonials from patients that write in to say how our products have made a difference to them, their life saving, and that thing. It just makes you understand that this is why I'm here. This is why I come to work every day. You want to make sure that you're providing key therapies to patients in need and in areas with a lot going on.

One of the things that we look at in Gilead—this is at the direction of the leadership team led by the CEO—is looking at everything from an enterprise perspective. Not just in your own little box and your own little world, but look at it all across the enterprise. People think, oh, the United States or North America, South America, there's Asia. We provide access to products to patients in much needed countries. It's incredibly rewarding to hear that.

Like I said, we're [...]. In fact, I got to leave and go to after this. That's probably going to fill my day. It's worth it in the end when you see the difference that you're making in the lives of patients. Like I said, it's very humbling.

As leaders, you just feel like, like I said, you just want to serve. You want to be able to provide that to the individuals. Quality, that's really important to make sure that it is of the highest quality. We saw the standards and certainly at least the regulations that are imposed upon it.

Mike: That's great. I imagine it just gives you great motivation each day to know what the products Gilead produces, are doing in terms of the good that they produce out there. That's great to hear.

Josie: Valerie, I know that you mentioned your grandma previously being a strong example for leadership for you. My question is in lieu of Women's History Month, is there another woman you want to highlight as a great leader?

Valerie: There are so many, to be honest with you. I think I'll just keep it close to home and talk about the leader of PDM who is Taiyin Yang. She's a very, very humble individual, but just a very accomplished individual. She's been in Gilead for almost 30 years.

She was very instrumental in a lot of these therapies coming into market, like the fixed dose combinations, combining two, three, four actives together to be much more effective, especially in HIV therapies. She was just honored with an award in the National Academy of Engineering.

She's very, very demure, very quiet, very silent, strong, tight, and least, like I said, by inspiring, motivating, and giving the freedom to explore, to try new things, and to be innovative. I think that's one another leader that I definitely admire quite a bit. There are a lot of them that I've met.

Josie: Oh, I'm sure.

Mike: That's great. I really appreciate the insights there. We're getting close to our time here. I want to get moving to our next segment. One last question, Valerie, and maybe it's more of a fill in the blank. It's like a thought around leaders that you admired and maybe just to fill in the blank. The leaders that I admired most did what? What were some of the key characteristics that you were left with?

Valerie: The leaders I admire most listen to understand. We see some leaders that seem like they're listening to you, but they're just waiting for their turn to talk. There are other leaders that I've encountered that really listen actively, ask some very point questions, and then you can certainly have that discussion and get out of that conversation what you need.

I really admire leaders who communicate up, down, and across the organizations, and make it clear to everyone what the goals are and where we're going. I guess those are the two things. If I had to fill in the blank, I would say, listen and communicate effectively.

Mike: That's great. I love that. All right. We are going to move on to our next segment here. As has become a tradition, we'll have a little game, and then we're going to do some of our key takeaways. As I mentioned earlier, I've got a whole sheet full of things, so I am not going to be lacking anything to talk about here.

First, let's jump into our game. As a little surprise, I'm going to lead this one this time. Valerie, if you're able to stick around for this one so I'm going to get you involved here, too. Let's talk about what we're going to do here. We're going to do a little Gilead trivia. If the internet is correct, I will have all the correct answers, but we'll see if you guys do.

Valerie: Do I get to play, too?

Mike: Yeah, you get to play too. I'm going to make you go last on these, Valerie, because you might have a lot of these answers.

Valerie: I may not, though.

Mike: Yeah, and no fair using the Internet. No googling right now.

Courtney: I was just going to ask if [...].

Josie: Yeah, I was about to pull up our window.

Mike: It's a multiple choice, so we'll go with that. I tried to make them hard, Valerie. We'll see how it goes.

All right, first question. When was Gilead founded? I've got four options for you. A is 2001, B is 1987, C is 1945, or D is none of the above.

Josie: Oh, you have to throw the D.

Mike: Yeah, we have our curveball there. What do you guys think? Courtney, I'll let you go first.

Courtney: I'm going to say 1987.

Mike: Okay.

Josie: That's my guess as well.

Mike: All right. How about you, Valerie?

Valerie: It's 1987.

Mike: We'll see. We'll reveal the answers here in just a moment. We have the expert there. All right. Okay, next question. Michael Riordan is the founder of Gilead. How old was he when he started the company? Answer A, 19. He was really a prodigy. Answer B, 24. Answer C, 29. Answer D, 59.

Courtney: I really hope it's 59, because if it's any of the other ones, I'm just going to pack it up and go home. Just kidding. I choose 59.

Mike: How about you, Josie?

Josie: Try to be different and say C, whatever that was.

Mike: Okay. How about you, Valerie?

Valerie: I never met Michael Riordan. I want to say 29, too, because I heard he was a prodigy, but I didn't think he was that young. I know he's young, but not that young.

Mike: All right. We'll go Josie and Valerie at 29 and Courtney at 59. Okay, question three. This one is a little bit more involved here. Where did the name Gilead come from? A, it was the name of a Star Wars character favored by the founder. B, it was the name of the region in the Middle East where the first genuine pharmaceutical product was thought to have come from. C, it was a combination of initials from the founder's childhood friends, or D, it was the name suggested by the primary venture capitalists funding the company.

Josie: I'm going to say B, because Gilead, that's a lot of friends. It's an acronym. That's not too many, but that's more than what I have. I only have a very close circle.

Courtney: I agree with Josie. I think that sounds like the most plausible answer. I would really hope it's not D.

Valerie: What was B again, Michael?

Mike: B, it was the name of the region in the Middle East where the first genuine pharmaceutical product was thought to have come from.

Valerie: And the first one was?

Mike: It was the name of a Star Wars character favored by the founder.

Valerie: Okay, I'm going to go with B, too.

Mike: Okay, all of you are going with B. Okay, the last question, question four. What was Gilead's first product to hit the market? Again, I hope the Internet was right here. Is it A, Vistide, B, Viread, C, Remdesivir, or D, Gilsimovir?

Courtney: Valerie looks like she knows.

Valerie: I better.

Courtney: I'm going to say D. I think it's an antiviral, but not Remdesivir.

Mike: How about you, Josie?

Josie: Yeah, I feel like if not C as well, because I feel like that's a little bit more current. I don't know. I'll just go with B just to be different.

Mike: Okay. How about for the final answer from Valerie?

Valerie: I want to go with A, Vistide. Yeah.

Mike: All right. She can pronounce it correctly, too. I didn't think I pronounced it correctly. All right, that was awesome. Okay, let's go through these real quick.

When was Gilead founded? The answer is B, 1987. Everybody got that one correct, so five points for everybody. Second question. Michael Riordan, the founder of Gilead, founded the company at the age of 29.

Valerie: Oh, good. Yey.

Mike: Josie and Valerie. Courtney, I agree with you, but 29 is pretty young. I was 30 when I founded Enterey. How about that?

Valerie: You're right up there with him. You're right there.

Courtney: I've got two years to catch up. That's enough time. I'll come up with something.

Valerie: My time has passed.

Mike: All right. This was my favorite question to research. It's about the name of where Gilead came from. You are all correct. It was named after this region in the Middle East where the first genuine pharmaceutical product was (I guess) deemed to have come from. I think it was called The Balm of Gilead. It was the Gilead region.

Valerie: Exactly.

Mike: That was really fun. I had to come up with some really good secondary answers, because I just had to come up with something that maybe sounded real.

Valerie: When you talked about the Middle East, that threw me off, because I know about The Balm of Gilead and everything. I'm like, hmm.

Mike: That was pretty cool. I was going to say his college roommates initials, but then they would have thrown off my previous question if you guys thought maybe he was 19. All right, these are all coordinated, you see.

All right, the last question. Which was Gilead's first product? I want to first congratulate myself for coming up with a fake product that somebody picked.

Courtney: It was me.

Mike: Gilsimovir. I thought for sure, if I just put Gil at the beginning of one of these names, maybe somebody would pick it.

Courtney: I think it was the last part which it's just standard. I said, oh, yeah, antiviral.

Valerie: Exactly. And it sounds legit, doesn't it?

Mike: I should go into the pharmaceutical product naming business, I think. The actual answer was, how do you pronounce it, Valerie?

Valerie: Vistide.

Mike: That was in mid (I think) 1995–1996, somewhere in there. The other one that I didn't get to work into this was Tamiflu was discovered by Gilead as well, even though now, I think Roche markets it. I always thought that was fascinating, how the world works.

Valerie: I'm glad I got that right, because we used to manufacture that active.

Mike: That's great. You have four, Valerie. You've passed with flying colors.

Valerie: I wouldn't be able to go back to work if I didn't.

Mike: That's right. We would have to dub the recording. All right. Hey, let's move on. We got a few more minutes left. Let's move on to talk about some of our key takeaways. Who wants to go first? Josie, Courtney?

Josie: I can go first. The key takeaway that I really got from Valerie is to keep learning, to keep growing, and to be able to see the bigger picture. Those qualities are what makes a good leader.

Mike: Awesome. How about you, Courtney?

Courtney: I think what Valerie mentioned about leaders listen to understand and not listen to respond is absolutely critical. I think it's excellent advice. Then also, what Valerie was mentioning about stepping out of your comfort zone, I think it's excellent feedback, because that's how you develop, grow, and make yourself a well-rounded candidate, a career person, and part of the industry. I appreciate learning about all of that and taking that with me throughout the rest of my day, week, and beyond.

Mike: Awesome. As I mentioned, I have a whole sheet full of items I could bring up. I want to thank you, Valerie, for sharing your thoughts here. I think one that jumped out in the very beginning was when you mentioned, quality is not the police, quality is a partner. In the work that we do with Life Sciences, it's so important. Quality is there to serve as a very important job.

We're not the police. They're there to make sure that the product is healthy, safe, and work with you to make everybody successful. I highlighted that one. I think the one that really jumped out to me was when you mentioned the guidance that Daniel O'Day provided, which was that every employee deserves a great leader.

I love that one. I just thought that was really insightful. I see it in the work you do at Gilead. Hopefully we can apply that across the board for everybody here at Enterey as well.

All right, any parting thoughts before we wrap up?

Valerie: I want to thank you all. This was so enjoyable. It's so nice to have the conversation and listen to the questions. I've learned from you and some of the questions and thinking about things to think about as I go forward in my leadership journey. Thank you for having me. I really appreciate it.

Mike: You're welcome, Valerie. Thanks so much for joining us. It was a pleasure to chat with you and hear more about your journey. It's just so appreciative of you joining us here today.

What makes a good corporate citizen, and what makes one less solid? Whose job is it to find out? Today’s guest will answer those questions and more.

Tommi Papson is the president of Regulatory Consultants Group. She’s also an ex-FDA investigator and Consumer Safety Officer, among other things. Both as an FDA investigator and now as a consultant, she works to ensure that companies play by the rules, but those two different roles require different approaches. 

Listen to the episode to learn more about Tommi, her role as an investigator for the FDA, and how it stacks up against her current consulting position. She discusses the different types of leaders she’s encountered, the challenges she’s faced in her career, and the differences between how she was received as an investigator vs. a consultant. 

• How Tommi ended up at the FDA
• Different types of leaders Tommi experienced in different environments
• What Tommi sees in people she wants to mentor
• Characteristics of solid corporate citizens vs less solid ones
• The differences between how Tommi was received as an FDA investigator vs a consultant
• The biggest challenges Tommi faced in her career
• A favorite story from Tommi's days an an investiagor
• Some basic rules of the road that anyone would benefit from
• Key takeaways from Tommi’s interview
•  

Mike: Our guest today is Tommi Papson. Tommi is the president of the Regulatory Consultants Group. She is an ex-FDA investigator, consumer safety officer, and member of the DHHS FDA International Cadre Investigations.

After leaving the agency and having adventures of a lifetime and some experience with other firms, Tommi co-founded Regulatory Consultants Group along with other ex-FDA experts. The audits continued from cradle to grave to document review in the steps of a serious but fun mock FDA audit to remember.

Working closely with the DOJ, FBI, OCI, and state and local government agencies, Officer Papson enjoys the challenge of escalated FDA 483s of OAI firms, warning letters, seizures, recalls, and civil and criminal money penalties. Her career spanned hundreds of investigative activities and inspections in bioresearch monitoring, pharmaceutical, medical device, consumer complaints, and whistleblowers from routine assignments to unannounced for-cause inspections.

I'm sure those are fun. Hopefully, we'll hear about it.

Violators were placed on the Application Integrity Policy List. In addition, the FDA's public health concerns, illness, life and death reports, and adverse events inspections were part of her day-to-day activity as an investigator.

Outside the office, Tommi is a painter and a sculptor. She enjoys photography, global travel, and volunteering with professional organizations. She brings her FDA experience together with current regulators to industry groups like the Pacific Regional Chapter of the Society of Quality Assurance as their president and as a past president of the Orange County Regulatory Affairs Group.

Tommi lives by the following advice that in the regulated world if it isn't documented, it doesn't exist. Let's welcome our guest, Tommi Papson. Welcome, Tommi.

Tommi: Hello, everyone.

Mike: Thank you so much for being here. That introduction, boy, I can't wait to hear more about your background and experience. It sounds pretty exciting.

Tommi: Normally, the whole thing isn't read or discussed. When I worked for the FDA, I was known as Trudy Papson, so after leaving and starting my own company, it was like that name has a reputation, so I went by my grandmother's nickname.

Mike: That's great. Interesting to hear. Tell us about that. How did you find your way to the FDA and then ultimately becoming an investigator?

Tommi: Radiation. I was in the Air Force. I want to be a pilot. When I passed all of my tests, I went to Lackland Air Force Base to be a pilot. After I got through several weeks of boot camp, I said, oh, when do I start my flight training? They said, well, I'm sorry, you're too short to be a pilot. I said, I was the same height when I was recruited in Pittsburgh and when I took all my tests. Well, we're going to put you in something else.

Instead of flying the planes, I got to watch them. I got to watch the radar and learn about radiation. Then after that, I got into the medical field and medical radiation. Of course, the medical world involving medical devices, pharmaceuticals, and all those wonderful things.

Somebody came to me one day and said, you really write great SOPs. You got to work for the government. I went, oh, that sounds interesting.

When the government came to the hospital I was at and said, would you like to work for this, I said, certainly. I started out basically at the state of California as an environmental health specialist writing procedures on what the state inspectors would look for at radiation facilities, [...] in hospitals and different areas such as that. Then, that went from the state to the federal government.

Mike: That's pretty elaborate. It sounds like a pretty interesting path. Actually, I had no idea that you were in the Air Force. So excited to hear a little bit about that. Based on that though, you've spent time in the military, public sector, private sector, and now working with your own corporation. I'm curious from a leadership perspective if you've heard or experienced different things, characteristics, and types of leaders that you can highlight the differences. Do you notice any key differences among those different environments?

Tommi: Absolutely. There's a difference in every one of the sectors that you mentioned at different levels, different strata, and different silos as I like to call them. If you're in one environment, there's a silo basically where your job is where the leaders come in, knock on the door of your silo, and then might go away. There are certain areas where the leaders are right in there with you, and then there are others which we all know that leaders sit at the top, but they don't know what goes on at the bottom.

As far as the leadership world that I have interacted with, I've interacted with Fortune 500 CEOs that asked me if I had an appointment—which I probably didn't need one—to people that just started work and wanted to get into a career. Some of those people actually became leaders.

It's always interesting to see somebody who's starting out not just as a student but as a worker where they seem to have that potential of leadership right in the beginning. If they can get with somebody that's going to mentor them or have a path to get there, you can almost feel that and see that. That's one of the thrilling things of being in the different areas I've been in to watch.

Mike: Tommi, that's interesting stuff. What's really intriguing to me is when you refer to some newer employees or employees that are early in their career, you can recognize some of those leadership characteristics in them so that you are drawn to mentoring them. What are some of those things that you see in some of those individuals that you really are attracted to?

Tommi: The passion for what it is they do versus wanting to go to work from 8:00 AM to 5:00 PM. You meet somebody that has that passion that wants to know about it, wants to understand it, wants to find out everything they can about it versus the person that's there for a job. I don't see them coming through the whole area of becoming into the leadership world.

For people who seem to have a passion to want to do something, it doesn't matter what area they're in. It can be in receiving. They have a passion to do what they do. They're going to move up in the receiving world.

They have a passion to do something in the front area as a receptionist. She can end up maybe as an administrative secretary doing everything she never thought she would do other than just answer the phone, but she's got a passion for sitting there and doing what it is she really loves to do.

That mentality that I think is inbred in certain people is I have the desire to do something and I want to do it right. With the government, you do it right or you don't do it at all kind of thing. Growing up, I had that same feeling with people that I met and watched people grow and change. Usually, it's people that it's a monotonous life for them. That's not a leadership thing.

Courtney: I know you're passionate about all types of nuclear medicine and then regulatory affairs. Can you tell us a little bit about what you've done after the FDA in terms of continuing with your passion with regulatory affairs?

Tommi: One of the things I did, I retired. I left the agency when there was a commissioner that said, people were no longer volunteering. It wasn't specifically spelled out in your contracts with the agency, but it was, you're going to be somewhere for three months where they hate your guts, they don't want you to come, you're going to stay there in that country for three months, you're going to move around from one company to another, and then you can come home for several weeks, write up your reports, get your information together, and then go back to a different place.

When that three-month ED came out, I said, I think it's time to leave. I basically retired on a Friday and started my own company on a Monday. Several other people did that same pipeline thing and went oops, we don't want to go there. We did that and started that. I went from knocking on doors of companies saying hi, I'm here, to now being paid to go to a company.

I work for the government so you know. Now, I'm getting paid to go to companies to do what I did with the agency. It was like, come in and put my people through an inspection. Make it real and make them feel it. They need to understand the importance of our stock going downhill, our CEO having a penalty, and everybody getting fired because they're the scapegoat. We want you to put our company through that. Can you do that?

I said, I love doing that. You're going to pay me to do that, and I'm going to travel around the world. That's what I did afterward. That's been the passion I carried through it. It's still fun to do and I still get hired to just drop in and innocently come in to knock on your door.

Courtney: You mentioned going places where people don't love that you're there. How do you stay resilient in the face of that, especially if it's thousands of people at a company and it's just you showing up?

Tommi: I guess I have this little part of me that says if I know I'm sent there and I'm in there for a for-cause inspection, you hurt some innocent person. If I can say to myself, I know that you know you've hurt some innocent person and your company is proceeding to do that, that's not right. Let's see what we can do to find out if you can correct it. If you know about it, then let's put it together so that you can fix it, or the agency will fix it for you.

The passion going in is you've got a problem, let's work together. I basically go in as an educator, not a hammer because I'm too short to be a hammer, but the effect is I'm here and let's see what we can do.

I guess the way that I carry that through is there could be a table with six lawyers across from me saying, I'm sorry, you're not permitted to talk to anybody. That's okay. They don't need to talk to me. But it's June and I don't have vacation until December. I don't know where you're going, but I'm going to be here, so let's all talk. The interesting part of working through and doing that now is the same thing. It's let's play.

Mike: That's great. I've got a curious question. You've gone to meet with people at companies as an FDA inspector, and you've gone to meet with people at companies as an external consultant preparing them to deal with FDA inspectors.

I imagine you've seen the best of people and the worst of people perhaps in those experiences. Maybe they were either solid companies that had great compliance with regulations or maybe they had some issues, but that doesn't necessarily change how they act as leaders in the organization. I'm curious if you've seen different sides of these companies. What were some of the leadership characteristics of those that were solid corporate citizens versus not?

Tommi: One of them would be to meet with the FDA. One of them is, oh, yeah, you're here and we'll respect the fact that the agency wants to know about us. There's leadership that doesn't ever want to see the FDA, and there's always a fall guy. Usually, somebody's the director of something or another. That's the leadership of a company that could be not running or operating as well and as safely as they could or should be.

Courtney: How do you see leaders lead the people that they're essentially serving and their employees in those situations as well? Do you see them assisting? Sometimes, they turn and run a little because they're frightened for themselves.

Tommi: A really good leader on inspections and mock inspections I've been on around the world wants to be part of it. They want to know what the staff is doing. It's not that they've dispensed with everything that is your responsibility, please go off, and do your job. You're paid to do your job.

Really fantastic people want to sit in, watch, and see what it is not as an observer but as a participant in this is how I think our company should run and these are the people that I trust that are going to do that. If it's okay with them, is it okay if I sit in? Absolutely.

A good leader is willing to sit in, go through, and watch what the staff is doing, not just walk in, sign a document, and say, yeah, we know you're here. Then, at the closing of the inspection, they're there. That's usually the leader that is going to receive a 483 at the end of the inspection because they do not want to participate in what has been going on. That's really just an indication for me right out of the get go. That is how it works.

Mike: That's a great perspective. Wanting to be a part of it and knowing what's going on is what you described. The person that's just signing the document maybe either doesn't know or doesn't want to know what's happening and what it sounds like.

Tommi: Many times, the person that is at the top of the organizational chart, whenever an agency inspection happens, one of the first things an investigator asks is the copy of the organizational chart. We're going to talk to this person down here, but I'm going to want to meet with this person, this person, and the top person because if there's an escalated action, that leader is the person that's going to answer to the Department of Justice, the FBI, and the Office of Criminal Investigation. It's not going to be the regulatory person, directors, managers, or vice president. It's going to be the leaders that are running a company that could be manufacturing, distributing, or doing something that they could be doing better.

A good leader is in there to say, you know what, we're ready to do that better. We understand. We want to do that better. That's a great leader. They're willing to say I think you found something and we're going to address that before you leave today. Leadership can step up and say, we see this, and we'll take care of it.

Mike: That's a great example. Curious about your additional insights into that one. I've worked with some various clients and supported some inspections, and one of the objectives was always, hey, if we can address this wall, our inspectors are here, let's get it, let's turn it around, and let's see if we can present it to them. They were always eager to do that.

Tommi: That's a bonus.

Mike: I was going to ask, do you like to see that?

Tommi: If you're out there doing consulting and you're working with a company, one of the good pieces of advice I have is you really want to offer the FDA everything that you can do and say right there while the investigator is there because you got to remember, they only have a snapshot of time. They're taking that snapshot, they're taking that back, and that's your history for many, many years until somebody else comes back.

If you're able to interact with them and have management, your leadership is sitting there saying, you know what, here, we're going to talk about this by tomorrow morning. Do you want to come back? We're going to address this tonight. Everybody's going to work over. And they really mean that. A good leader will say, what can we do? What is it you need?

I can't act as a consultant. You can pay them, they can tell you what to do, or just ask your staff what they would recommend. I'll be back in the morning. Then, a good leader says, let's get pizza.

Rishi: Tommi, you mentioned this earlier. Can you talk about the differences in how you were received coming in as an FDA investigator compared to as a paid consultant to come do these mock audits?

Tommi: There are certain companies that pay me to come in anonymously. Basically, I'm knocking on the door and saying, hi, I'm here with an agency. I'm basically sometimes told, do you have an appointment? I don't need one.

As a consultant, a fun, really good thing to do is if you want to have a mock inspection, from your receptionist down to the CEO, they're involved. That involvement is going to put them through. I'm pretty much going to put them through getting all the way through with a walkthrough and with the documents.

The entire thing that I would do is a small capsule of what an agency investigator is looking at. I'm able to walk in there and say, I'm here to do this and I want your cooperation. I don't want to say your companies pay me a lot of money to do this, but the end result of doing a paid consultant job versus going into an agency inspection needs to be the same thing for me.

I hope it is for most consultants. You want to do what you can for that company that you're walking out with. You want to know when you walk out that you've done what you can that day in that area that you've been in because you don't want to go home and watch on the news tomorrow that all of a sudden, there was a recall, problem, or something in an area that you looked at, and you just were in a hurry, you got out, and you did it. That's not something I could ever have lived with.

Mike: It seems like a common theme that you touch on is to have buy-in from top to bottom that creates the best client from either you coming in as an FDA investigator or from a consulting capacity.

Courtney: It's all in the name of patient safety. That's the intention. That's what carries through. It's not done just despite some sort of company. It's these products are going into people, whether it's a device or a drug. Safety is the reason that they're there, so having companies who are compliant probably cared very much so about safety as opposed otherwise because unfortunately, there is a spectrum of that in the industry.

Tommi: Courtney, you hit that right on the head. If you think about somebody who is doing the same thing every day and they're writing SOPs, doing submissions, or manufacturing, sometimes they lose sight of this widget is going to go into somebody or this sterile device that may not have a good seal is going to go into somebody.

For somebody who's routinely doing the routine things over and over, good management and good leaders are going to walk in and say, everybody, what are we doing? Is there anything else we can do? Is there anything else we need?

Good leaders are right in there. They're walking the floor. I've had companies where they said they've never seen their bosses. I was like, what? That shows later. Not that I would say that's intentional, but that does show up.

Mike: It sounds like whether you are going in as an investigator from the FDA or as a mock audit leader, you encounter people who can demonstrate their leadership at all levels of the organization from the receptionist to the site head or the CEO, and everybody in that whole list of people that you would encounter have the chance to demonstrate their own leadership. Would you agree with that?

Tommi: That's the way it should be. It should be that way on every inspection, every audit, and every consultation. Everything that you go through with an interaction with another company, another person, and the way they're doing something.

By the time you're all done with the FDA, you're doing what's something that's called an investigation operations manual. You'll do a closeout every day. You'll sit down at the end of the day every day, and you will give less 30 minutes or so and a sandwich of here's what I saw today, here's an observation that I have, or here's an idea that I have. Tomorrow, I might be going to have a discussion about this area and this problem or concern. I'm going to have more questions, and I'll be back to discuss that.

As a consultant, I would be doing the very same thing as I'm here, I see this, and I'd like to expand a little bit on that. Can you get somebody in to talk to me tomorrow? They'll have overnight. You guys all talk about it because here's an area I'm going to focus on tomorrow. I want everybody on the org chart that I have and everybody's signature. I see that he signed a training document, I'm going to ask to interview them tomorrow.

I do that. I got their names, but one of the little things you do is say this person might be really fatigued at what they're doing, so let's bring him in. Let's give them a chance to talk about what it is they do and let them talk about that in front of a representative of their department or in front of somebody who's a consultant acting as an agent that could help them later or really hurt them later.

The learning experience is when I walk out of there, I want everybody that I interacted with to know that the leader knows what it is you do, and they're going to appreciate what you do because after I'm done with them, they're going to be happy that you work for them.

Mike: Hey, Courtney. A lot of our clients we work with have great ideas on how to improve their business, but they just run into challenges that seem to get in the way of accomplishing their goals. Have you ever seen that?

Courtney: Yeah, of course, it happens all the time. I've seen clients struggle with a lack of visibility into all the work that's happening within their organization, I've seen clients that are focused on manual tasks, which takes away from focusing on the actual project work, and I've seen leadership struggle to make decisions due to lack of timely information.

Mike: That's so true. It seems like just knowing the problems to fix is only half the battle. How do you help your clients address those challenges?

Courtney: We of course first work with our client to design a structured management process that fits their culture and team. In a lot of situations, we bring in tools like Smartsheet to help the entire project team be more efficient. With the help of Smartsheet, we were able to create dashboards, automate routine tasks, and have the information ready in real time to help support leadership's decision-making.

Mike: It sounds like you not only execute on the project but your work helps everyone get more done with less work.

Courtney: I hope so. Smartsheet is a powerful tool, and my clients seem to be really happy with it.

Mike: That's great. If somebody needs help on their project, what should they do?

Courtney: They should check out enterey.com and schedule a call with us to see how we can help.

Mike: Sounds like a great idea.

Courtney. Thank you.

We've talked about these situations where you show up on the doorstep, you're well-received, and people participate or not. What's one of the biggest challenges that you faced throughout the duration of your career?

Tommi: I guess one of the biggest problems is knowing that I'm going in a for-cause inspection where there's been a death or a hazard, somebody's had surgery, or many people had surgery. If you're familiar with what's called a MedWatch report or MedSun report, companies, doctors, and nurses get to tell the agency something's wrong.

If you're going through the country, the agency [...], and they're getting a report from Florida, Michigan, California, Hawaii, England, or Germany that there's been a problem, there was an investigator singling that out, and they're putting that together in a package. They will knock on the door and want to see what's been going on.

When you're sent in to someplace like that, you're basically going in. You're not telling why you're there, but you're there to do something that the agency has sent you to do. The biggest challenge I had was a company that we knew there were things going on and the Department of Justice had a flare-up of a question about them. I was sent in and went in with a team of two other people.

Normally, a good investigation or inspection of a good company is about three days, maybe four. If there's a lot of information and they're doing a lot of maybe class three devices, you might be there a week. If it's a class one or two, you might be there for 3–4 days.

This company was doing things and we knew they were doing it. They had a lot of complaints, but they failed to tell the agency about the complaints and they failed to tell them about the adverse events. Basically, my job was to go in and find out that they knew that and they didn't want me at the door, told me I didn't have an appointment, and asked me to come back.

Basically, you go back, but you're bringing the United States Marshal with you and it doesn't look good for everybody. You go into the lobby and you tell everybody, you might as well go home for the day. You don't really want to do that, so you want to try to get into the door and issue what's called the 482, which is Congress says you have the authority, you've taken an oath, you swore to go in, and treat them fairly, and then proceed and do what it is you need to do.

The whole thing is to find evidence. An agency representative going in is to find evidence for prosecution. Like you mentioned, sometimes you're not received well. If you're going to accompany where you're sent and there's a for-cause, somebody's been hurt and the whole job is to find out why did you know about it, when did you know about it, and how many other people have been or could be affected tomorrow, the next day, and the next day?

A company that met with me decided that the employees weren't going to talk to me. I basically spent three months at their [...]. Everybody accused me of having a trailer in the parking lot. I didn't have a trailer, I just drove down every day.

It ended up in the paper that after an FDA audit, 85 people lost their jobs and a company went out of business. That was not the FDA's fault. The FDA found that there were children having their thyroids removed because this company's analyzers weren't accurate, their assays weren't accurate, and they were cheating on little lines that they were making.

We spent some time trying to find out who knew that, how much they knew it, and how long they knew it. That became a criminal prosecution. That was one of the largest settlements in the history of the agency. It was a time-consuming thing and they didn't want me there, so they presented every day. Then, the president got a lawyer, and I would talk to the lawyer, not the president. The director and his regulatory staff would not be there. His lawyer would be there.

I was talking to the lawyers asking them questions about things, lab journals, specific dates, and specific gravity of this. The lawyers were looking at me like, we just can't do this. We're getting paid to sit here to have you ask us these questions. We have no idea what you're talking about. I said, really, I'm not going anywhere. This is it. I'm here. Either I talk to them or you can keep asking the questions. It doesn't matter to me.

Have you ever seen an FDA inspector with a green journal? That's a legal document. That's your diary. You take your little green journal, open it, sit back, take notes, and write your notes. Then, when you close that journal, it's like, I'm really done talking to you. Please get me somebody else that'll really respond because we really, really want to wrap this up this year.

Probably one of the most challenging things was just face-to-face with lawyers because the leaders felt a penalty was coming and a penalty did hit them.

Courtney: The Fifth Amendment protects your right to prevent self-incrimination. That probably does not apply in this situation, correct?

Tommi: Correct. There's criminal activity. You're selling something you know is a problem. If it crosses a state line, it becomes federal. If you say you sent something in the mail, then you've involved another agency. That's how all these fines build up.

In one of the cases, there was a whistleblower that we met at Denny's, and we met several times at Denny's. Basically, they tried to let this employee go because he was unhappy with something that was happening. He was charged with being a disgruntled employee and was put into a position of no leadership authority. He was bumped down. He was put aside and he kept saying, you got to do something. I can't watch this. You have to do something.

He finally told the FDA, and the FDA did something. He got a very big million-dollar settlement out of that case because he was a whistleblower who knew facts about a company that had continued to do things that were not safe, and public health had been affected.

That's the whole mission of the agency. If you know about it and if we find out about it, then that's where the bad guys are. There's a very small percentage of bad guys and there was a profit thing. They were making a lot of money. I can't name them, but it's in the press.

The most challenging thing is to know that you know that something's wrong and find the evidence to prosecute them. It's like the police. They have to follow you until your tail light goes out and you're like, oh my God, my tail light's been out. I didn't know that.

Mike: I think it's a really interesting concept and thought process. We hear a lot about, oh, this person could go to jail. You actually have seen that. I've been fortunate in my career and working with various companies that the people that I've worked with have been very concerned about that not from their own safety or freedom per se but because they do care so much about patient safety and patient health.

You got to experience the good and the bad, it sounds like. How frequent were those instances? How often did you find those companies that you had to stay for three months and that took away your ability to really expand the reach of the agency and make sure the broader industry is doing well?

Tommi: As a bonus, I got to train people. I got to let them shadow me. As one of the bonuses of what I did, I see your people would be able to follow and see what are the techniques that we have. How is it that we get people to really go up to a chalkboard and write down where this thing short-circuited? You can draw that on the chalkboard for me? Sure, that'd be good. Then you see the camera comes out with the investigator and the company says, I'm sorry, you can't take pictures. Really, you don't want me to take pictures? Then, they call the lawyer.

There's a whole long series of things that happen with the good things and the bad things. When you have the good things happening, it's a really exciting bonus. You get to enjoy that. Most of the people that I have worked with in the FDA and in the state of California really enjoy what they do not because you're finding a criminal offense but because you're out there to say, I have seen 100,000 things almost like yours and I bet you. I can give you an idea. I can walk in here in three hours and give you a tip on where it is I'm going to be tomorrow. Let's just talk about where I think it is. We may have a common ground where we may have a discussion where your management really would like to talk to us, or if they don't want to talk to us, that's okay because we'll be talking later.

The good thing is you get into a good company and they're there. Let's do a walkthrough. One of the techniques I did—maybe as a consultant, you've seen this—is you can do an audit. The company walks you in, they sit you down in a conference room, give you coffee, and then they'll show you the slides of their company.

I never did that. I walked right onto the floor. Open the doors and let me in, not in the lobby and not in your conference room. I'm going to walk in there right into the back and see what's going on. That's the fun part of it.

Then, when it's a good company, they're going, yeah, over here. The other company is like, I'm sorry, we're doing manufacturing. If you still want to manufacture, then I need to go in there.

Mike: You're taking all the great work that us consultants did in preparing slides and making it less useful.

Tommi: I can tell you how to do it as a happy thing. You don't do it initially. You have discussions. They used to buy me chocolate donuts all the time. There was this rumor out there that Investigator Papson really likes chocolate donuts, so I go to a firm and there'd be chocolate donuts. The next day, there'd be chocolate donuts. They have profiles on the investigator.

Rishi: Courtney, how many slide decks do we prepare?

Courtney: I would say not too many. Only when they're necessary.

Tommi: That's okay. You can do a slide deck as long as it's not impeding something. A lot of the slide decks are let's look at our rehab 3000-square feet. I'm looking at everything, and then 1 ½ hour later, I'm just bored to death. That's the way I am with classes. It's like, oh, another slideshow.

Courtney: We emphasize adding value.

Tommi: That's good news.

Mike: At some point during that day, you'll want to see the overview, so we know it'll be used.

Courtney: You're describing the situations where lawyers come in, and then there are roadblocks. Has a company ever won against you?

Tommi: No.

Courtney: That's what I thought.

Tommi: When I issue a 483, which is the list of observations based on the Food, Drug, and Safety Act Code of Federal Regulation sections 800–1200, I know the law. It's just in my head. If I am at a firm and I give you an ultimatum, I'm going to say, this is what I see. If you can fix this and tell me it's okay, then you will not get this little observation.

An observation starts out and it's a canned thing that the agency has. All the regulations that have this little can thing. Then, there's the next sentence where the investigator comes in and says, specifically, you did this at this time on this day with this person. That specifically points out what's happened. That's what the investigator has to do.

Courtney: In our personal conversations, you've said that one of your favorite things is when people go to jail. I'm wondering if there is a favorite story you have. I know you mentioned the one about the thyroid device, but is there another story about somebody being convicted? I know you've posted some things recently on the OCRA page.

Tommi: There have been some clinical researchers. There's a thing called the Application Integrity Policy. That's I caught you committing fraud.

Fraud against the federal government is a really serious thing. There are doctors that have had jail cases. Their sentences get reduced sometimes, but they've been prosecuted and they can no longer work on any clinical trials. They can no longer work in a pharmacy or medical device company. They can no longer provide anything that's regulated by the FDA or the agency.

Bear in mind that $0.25 on every dollar, Department of Health and Human Services touches somehow. Food, drugs, cosmetics, and everything in the world is the Department of Health and Human Services, which is the umbrella over the FDA. Everything gets touched by the FDA, so there you are, you don't want to just keep doing that.

Application Integrity Policy is when doctors have seriously hurt somebody. An investigator's job is to find something that you can take to a jury. Pretty much, you want to take the evidence that a jury is going to understand.

This is a lot of technical stuff, they've done all this research, they've done all these fun things, they've made a lot of money, and they have a lot of fun times, but here in the end is their signature when they knew somebody died. Here's their signature on a training manual. Here's their slideshow where they talked about, oh, there's only one death or maybe there were two deaths. If there are more, then we may report those to the agency, but we think it might be the hospital or the doctor.

The investigator's job is to find out and find the evidence. The evidence is just given to a judge. First, it's given to the Office of Criminal Investigations. It was right here in San Clemente. I used to spend lots of time down there with them at lunch. The Office of Criminal Investigations looks at it, and then they take it to prosecution or legal counsel.

In that instance, that's the important part of somebody getting prosecuted, not because I like to see them go to jail. I like to see them pay the penalty for harming people. The fact that a doctor can ever work again I think is probably better than going to jail.

Mike: That would be very devastating. I agree. Let's take another look at it. I want to ask the question of all the companies you've walked into either uninvited or invited, you've probably seen some really good things too. What would you say to those listening who are going to encounter inspections or are going to just want to do their job well from a regulatory compliance standpoint? What are some of the basic rules of the road and rules of the trade that you would tell anybody, hey, if you follow these rules, you're going to be in pretty darn good shape?

Tommi: One of the crucial things for leadership to understand is that I talked earlier about the silo. You have regulatory people and you have manufacturing people. A really good program is everybody knows what everybody else is doing.

You don't want marketing to run the company, you don't want regulatory to run the company, and just always just go by the book. Every department should be able to sit down and have time together. Everybody needs to know what everybody else does.

That's very difficult in a company small or large to get somebody to understand why it is you want to sit there and read code books and why it is you want to know about these things versus why somebody in marketing wants to talk about something being the greatest, the best, treat this, and do this, but it's not really quite accurate.

They don't understand why that regulatory person is sitting over here saying, you can't really say that because that's not true. If we say it's treating something, we have to have clinical studies that say that. For good management and a company that really works well, everybody knows what everybody else is doing. You see the posters together. Everybody's interacting together.

I mentioned pizza. A lot of times, there are pizza parties after I leave. Everybody's getting together to celebrate. Whether they got 483 or not, they're together. A really good leadership program and management of companies is everybody knows a little bit about what everybody else does. But if they're siloed, then everybody is doing their specialty, not understanding.

Marketing has to know when they're selling this product that the regulatory is saying, no, we don't do that and this doesn't do that. Manufacturing is saying, I changed this product. I'm doing this and this will be faster and speedier. Wait a minute, design control over here wasn't told.

That's getting everybody together. A really good company and really good consultants will say, let's everybody get together. Every department head does a walkthrough all together.

One of the things I really like to do when I'm doing a mock audit is I like the CEO with me and every department manager not in their suits and ties. We're going to come together one day and just going to walk through. We're going to do walk through just as another employee. I watch them and see if they talk to people and see if people talk to them.

You need to know your employees, and the employees need to know you. They need to know that you care about them and that you're there for them. On your next consultation and consulting job, that's one of the things I would like to hear that this company does.

Mike: Get to know people.

Courtney: People drive results.

Mike: There you go, dropping the slogan.

Tommi: That's good. That's social media stuff.

Mike: Excellent. We're pretty close to wrapping things up here. I heard the doorbell. Pizzas come in. I have to make four different trips here in our virtual world.

Tommi: We did that one time at our board meeting. We were meeting virtually, and we just had Grubhub. Everybody got dinner at 6:00 PM.

Mike: I think that's the beauty of these services. Everybody can still have dinner together.

Tommi: We're trying to come out next week and be a real board and meet in person.

Courtney: Is that next week?

Tommi: Next Wednesday, 6:00 PM. Be there, be square.

Courtney: It's right around the corner, Mike.

Mike: It sounds really close to us.

Tommi: Where are you?

Mike: We're right in the Irvine Spectrum.

Tommi: This is up at the district right at Jamboree right across from AMC Theater.

Mile: Is that an OCRA event?

Tommi: It's the board meeting event.

Mike: Oh, not everybody's welcome.

Tommi: No, I'm hearing that somebody else is going to have an event soon that they're going to give me information on.

Courtney: Yeah. We're doing and organizing Chaos webinars with OCRA in April. Tommi and I were working on that and coordinating that. We have to fill out some paperwork.

Tommi: It's just one page. It's really easy. I'll help you.

Mike: If you don't write it down, Courtney.

Courtney: I did.

Mike: That was awesome. Tommi, I want to say thank you so much for being here and talking to us. Your stories are fascinating. I think we could probably keep talking for a lot longer, but in the interest of time, we're going to move on to our little game that Courtney has prepared. Afterward, we're going to capture some key takeaways from your thoughts too, but first, we'll do this game. Have a little fun. What do you think, Courtney?

Courtney: Yeah, it should be fun. What we're going to do is like we do in some of our previous episodes. It's just rapid fire questions, Tommi. I'm going to ask you a series of 10-ish–12-ish questions and as quickly as you can answer is what we're looking for. First thing off the top of your head, and then I'll ask Rishi and then Mike.

Let me know when you're ready.

Tommi: I guess I'm ready.

Courtney: Do you like cats or dogs better?

Tommi: Cats.

Courtney: Do you have a secret dish that you can cook?

Tommi: Tuna noodle casserole.

Courtney: What motivates you the most?

Tommi: Flowers.

Courtney: What is your favorite work memory?

Tommi: New boots.

Courtney: What's your favorite season?

Tommi: Fall.

Courtney: What do you have a hard time pronouncing?

Tommi: Disestablishmentarianism.

Courtney: What has been your favorite age so far?

Tommi: Nineteen.

Courtney: Would you rather fly or have super strength?

Tommi: Super strength.

Courtney: Do you own your own Netflix account or do you use somebody else's?

Tommi: My own.

Courtney: What is your go-to karaoke song?

Tommi: You ain't nothin' but a hound dog.

Courtney: Our last one. What is the last thing you searched on Google?

Tommi: Your company.

Mike: I was going to say Tommi Papson.

Courtney: Tuna noodle casserole, huh?

Tommi: It's the only thing I can cook.

Mike: I have so many more questions. We have a whole other podcast to go through now that you've answered those questions.

Rishi: Do we get the same questions, Courtney, or are they different?

Courtney: They're different. That'd be too easy.

Rishi: I was preparing answers in my own head.

Tommi: If we've learned anything today, reading it [...].

Courtney: Rishi, you're up next with new questions. Are you ready?

Rishi: Sure. Let's go for it.

Courtney: What was your last impulse buy?

Rishi: Phone.

Courtney: Which celebrity annoys you the most?

Rishi: All of them.

Courtney: What mythical creature would you believe was real?

Rishi: Zeus.

Courtney: What's your favorite pun?

Rishi: I don't know.

Courtney: What is humanity's worst quality?

Rishi: Importance of materialistic things.

Courtney: Where do you live?

Rishi: Phoenix, Arizona.

Courtney: Who is your favorite boss?

Rishi: Mike Ferletic.

Courtney: What's your favorite holiday?

Rishi: Christmas.

Courtney: Would you travel to the past or the future?

Rishi: Past.

Courtney: Okay, the end. Good job.

Mike: Rish, why did the mushroom walk into the bar?

Rishi: I don't know. Why did it walk into the bar?

Mike: He's a fun guy.

Rishi: What's funny is I really love puns, but I couldn't think of any on the spot. I follow a bunch of pun accounts on Instagram and I just couldn't think of any on the spot.

Mike: Sitting here observing, we have a lot of time to think, so we'll fill in the gap.

All right, Courtney, I'm ready for you.

Courtney: Are you sure?

Mike: Yup.

Courtney: All right. What's your favorite number and why?

Mike: Eight. It's my birthday.

Courtney: What is your favorite cake flavor?

Mike: White cake.

Courtney: What subject were you best at in school?

Mike: Math.

Courtney: What scares you the most?

Mike: There are a lot of things. Probably bugs inside. Bugs outside are fine, but bugs inside, no.

Courtney: Cats or dogs?

Mike: Dogs 100%. Sorry.

Courtney: I have both. It's fine.

Tommi: I have both.

Courtney: What's your hobby?

Mike: Right now, I've learned to sail, so sailing is a hobby. My wife has learned to sail, not just me.

Courtney: What is your favorite beverage?

Mike: Red wine.

Courtney: Then one more, if you had to be a Disney character. Who would you be?

Mike: Oh my goodness, my favorite character having two kids growing up, I think is Tigger. He’s the guy just because he's always happy and always having fun.

Rishi: Good answer.

Courtney: That's awesome. That's all I have in terms of the game. Thank you all for playing. I think one of these days, Mike, you need to flip the tables here.

Mike: I know. I was just thinking that. We're going to get to ask you some questions one of these days. That was awesome. I actually really enjoyed learning about our guest.

Tommi: I could do that right off the cuff.

Courtney: That would scare me, Tommi.

Mike: I really enjoyed the game, Courtney. It was great at learning about Tommi and learning about Rishi and getting to participate as well.

Let's move on to some key takeaways. As I mentioned, just great conversation. Tommi, thank you. What did you take away from this, Courtney? What can you share with us?

Courtney: I really think that leadership, being able to stand by the people that they lead throughout these difficult times for instance such as an FDA investigation, is really critical to be a good leader from Tommi's experience in what she said. That's such an excellent takeaway. Leadership characteristic is just being able to stick by your people, educate and support them, and not leave them to their own devices or play the blame game. I think that that information has been excellent to hear.

Mike: What do you think of Rishi?

Rishi: Courtney took my first one, so I'll skip that one. That was my initial answer. The other one I had was you mentioned that good leaders often start off as either students or workers before they become a leader of a large organization or a large group of people, which I thought was really interesting. It leads me to believe that they're able to have that same mindset as the rest of the people in their company and it ties into what Courtney just mentioned. I would say that that's my second biggest takeaway.

Mike: That's awesome. I think there were a lot of takeaways. Since I'm going last here, I'm going to mention two. One that really stuck with me, Tommi, was as Rishi was mentioning, some of these people that are new to the workforce are growing in their career. As a leader, having the willingness to reach out and mentor individuals is what helps those individuals grow in their career and become great leaders. That was just really insightful. It's a simple thing that's leading others in a way that may or may not get noticed visibly, but it's something that helps grow people in your organization, whether they stay there or they move on to other bigger, better things.

The other thing that I wanted to mention—actually, I think Rishi, you confirm this from Tommi—is that top-to-bottom buy-in. Leaders really look to get that buy-in in their organization. Getting that buy-in and making sure people are on board and on the same page may not always agree, but they get buy-in and people know why they made decisions the way they make it. That was a great insight as well.

Thank you so much, Tommi. We really appreciate you being a part of this and for hanging on for our extracurriculars here as well.

What is the secret to dealing with people and establishing connections? How does this help when transitioning to a leadership role?  

Sue Marchant is the Vice President of Product Management at MasterControl. In today’s episode, she talks with hosts Mike Ferletic and Courtney Boudreaux are joined by guest host Nancy Coughlin for a discussion. Listen to the episode to hear them discuss the goals she has as a product manager, the challenges of transitioning to a leadership role, and her early experience with developing and launching her own software.  

• How Sue got to where she is today 
• What a product manager does & the goal of a product manager 
• How Sue incorporated her team’s talents into projects
• Sue’s experience with developing and launching her own software
• Challenges of transitioning to a leadership role 
• The rise of remote and virtual work options
• Advice for connecting with and dealing with other people
• Where Sue is headed with products at MasterControl
•  

Mike: Today our guest is Sue Marchant. Sue is the Senior Vice President of Product at MasterControl where she leads all product development with an emphasis on infusing advanced data mining and analytics capabilities into MasterControl's cloud-based software for the life science. She spearheads initiatives around actionable, predictive insights, and optimized efficiency, productivity, and compliance.

In the decade prior to joining MasterControl, Sue worked in several senior-level capacities to lead natural language understanding, machine learning, and cloud analytics projects for NICE Systems Ltd., a cutting edge text and speech analytics software company that enables organizations to operationalize big data.

Her most recent role with the company was director of product. Among her other professional accomplishments, Sue founded and served as the Chief Product Officer of a SaaS company that developed applications to help hospitals recover the cost of donated prescription medications. She also worked for nearly a decade as an independent consultant in product management, quality assurance, and technical writing in the software space. We're really excited today to have Sue Marchant on the call. Let's welcome Sue. Welcome. How are you?

Sue: Hey, thanks. Great to be here. Excited to talk with you today.

Mike: Yeah, it's awesome to have you. Thanks so much for joining us. I was really excited to learn about you and your background. As we prep for this call, I learned about your very interesting path to get to where you are today. I thought maybe we could just start by giving you a chance to tell us a little bit about that. Tell us how you got to where you are today.

Sue: It's a long and unwinding journey. Whenever I hear the description of my career and what I'm doing today, I'm a little bit baffled by the description. It sounds a lot fancier than what I feel like I do, which is really helping people to make sense out of all of their data. I think everything that I've done along my career path has been about how do I look at what's in front of me and translate that into something that everyone can understand.

Way back when I started off on my career, I was actually working at a title in an escrow company, working full time, very busy role there, and learned that I was expecting my first daughter. I wanted to find a way to be able to work from home with her. This was 21 years ago, so there were not a lot of work from home opportunities at the time. But I found a role as a virtual assistant, which was kind of an unheard of thing back then and happened to be working for some consultants who eventually decided they wanted to create a little software program.

The software program they developed, I kind of helped them with some outsourced developers, started managing some of the initiatives they were doing. I didn't know that that was product management, but it was kind of the first time that I was involved in a project where we were developing software, but I wanted to become more involved and I asked them if I could create their help files. They said, do you know how to do that? I said of course I do. I downloaded some help file software, figured out how to use it, and began writing the help files.

Very shortly afterward, I kind of rebranded myself as a technical writer and I would go out and find clients. I would look for companies that were looking for a technical writer and I would send them a letter saying do you really need somebody full time or could I help you out?

For the next 10 years, that's what I did. I worked with software companies to develop their user manuals, their documentation, and their help files. As I worked with those companies, I often got involved in other aspects of their work. I would do QA.

As I was documenting their software, I would be testing it. I would find bugs. I would get more involved sometimes in helping to do a little bit of product management for these small companies. Really got more and more familiar with what was happening in software companies at the time, but very much on a consulting, individual contributor kind of basis.

At one point in time, my sister was actually working for a company for a hospital that had a very manual process where patients who were indigent would come in, they would need prescription medication, and they didn't have the money obviously, to pay for that medication. Many drug manufacturers have programs where if those patients file the right paperwork, the drug manufacturer will pay for their medication.

That was a really, really manual process. It involved a lot of paperwork. Every program was different. They kind of made it as hard as possible for these patients to get their medication for free. She came to me and said you know about computers, right? Could you help me figure this out? She kind of lost interest after a couple of weeks and she realized it would be a much bigger project than what she was originally envisioning. I did end up creating some software that was designed to really digitalize that process. I had no idea what I was doing in starting my own software company.

Mike: The best place to start.

Sue: Yeah. Trial by fire resulted in the rapid emptying of my bank account as I worked with offshore developers, but I did manage to create that software. It did work. I did eventually sell the IP to a company. I think I broke even overall.

I didn't have a lot of understanding of the tech world, data architecture, or any of the things that I would've needed to understand in order to make that a successful business. I really thought at that point in time, you know what, I need to go work for a real software company, figure out what this is all about so that I can be in a better position if I ever want to try something like this again. Spoiler alert, I don't.

I went to work for a software company and it happened to be a text analytics startup. Text analytics is all about taking in all of the text that you find in the world and making sense out of it. Whether it is recorded conversations, emails, customer complaints in a database, any form of text, that company would analyze all of it.

Thousands and thousands of hospitality card comments, for example. They would be able to take all of that text in, understand what it meant, and surface to the customers things like 40% of your customers hate the beds, think they're too hard. Twenty percent of the customers think that your breakfast is terrible. Give them actionable insights from that information.

I started working there as a technical writer. I wanted to just get my foot in the door and they were working on lots of exciting things. They were working with the CIA on some kind of exciting initiatives to help combat terrorism and so I started working as a technical writer.

As a technical writer documenting their software, I began finding bugs again, finding issues with the software. I moved into QA, quality assurance for software and I kind of worked my way up that ladder. Manual testing, automated testing, then kind of managing QA. As I did that, I started working with the product manager and the product manager was the one who got to say, here's what we're going to build. Here's the next thing we're going to have our software do. Here are the next set of capabilities we want to do and I thought, that's cool.

I want to be the person who mobilizes that army of engineers and helps them find the next capability that will really benefit their customers and their users. I developed a relationship with her, learned her job, and when she was ready to move on to her next role in another company, I threw my hat in that ring. I was hired on as the product manager and I've been a product manager really ever since. A couple of years ago, I went back and got my degree working on my MBA, and ended up coming to MasterControl. It's just a really long, not very clear path.

Once I found product management, I knew that was really what I was going to love and what I was going to really spend the rest of my career doing because it's so exciting and gratifying to have a voice in what we're developing and really being able to talk to our users, understand their needs, and make sure that what we're building is what is going to be the most helpful to them. It's just an exciting career and it's exciting to be here.

Mike: That's great. It sounds like a mixture of entrepreneurship, taking initiative, and finding what you really love to do all rolled into one and getting to where you are today. I was going to ask you because I've heard the term product management a lot and I've never really quite understood it. You gave a good explanation. Maybe just for those who aren't super familiar with it, can you give another little anecdote of what a product manager does? What is your goal as a product manager?

Sue: Sure. A product manager is responsible for understanding what users need. What are their problems, first of all? As they're using software or as they're going about their daily work lives, what are their challenges and then building into the software, the capabilities that will help them with those challenges.

For example, right now or fairly recently, one of the things I was responsible for was defining what dashboards we would have in our product. When I talked to customers, I would say, okay, tell me about what you're worried about as you're driving into work. What are those things you need to be aware of the minute you walk in the door? What are the things you worry about at night that you're thinking did we get this right? Did we remember to do this? Are we close to hitting this target?

I really wanted to understand all of their challenges and problems, all of the things that they were measured by. What are the things your boss is going to look at you and say you didn't hit your target? Let's measure all of those things and help you understand them.

My role as a product manager was to understand their challenges and then build into the product things that help them to overcome those challenges and things that would help them to be successful or to accomplish their goals. A product manager identifies those things by doing different kinds of research with users. And then it defines, for the software engineers, here's what we're going to build, here's what we're going to develop, and then really shepherds that through the development process. Works with the engineers.

They build something, we check it. Did that really meet the need? Does it help the users to do what they want to do? Then as we get ready to go to market, we do things like pull in customers to test it for us, to beta test it. Try this piece of software out and let us know what you think. Let us know, does it actually solve those problems and challenges?

Then helping some of our go-to-market partners figure out how to support it. Create the right help documentation, create the right training materials, create the right marketing materials to help customers understand what it is. A product manager is kind of from the cradle to, I don't want to say grave because we just aren't going to the grave, but through release, they're responsible for making sure we're developing the right thing and making it successful.

Mike: Very cool. That's awesome. Even in your description there, it sounds like throughout the course of being a product manager, and I imagine in the other roles that you held as well, there's a lot of working with other people in order to make things succeed.

I'm curious, as a leader today and as you grew as a leader, how did you incorporate the talents of people in your teams or people within the organization into these projects or these efforts to help the whole thing be successful?

Sue: That's an interesting question. Being a product manager, as you said, it's all about relationships. It's all about talking to people. It's about helping them understand your vision for something and making sure that software engineers understand your vision and what you're trying to accomplish. With other product managers as you're trying to lead them, once you pull them into your team, it's really all about helping them understand that vision. Make sure that they are creating the features that are necessary for the product.

As you transition into leadership, it's less about what you individually are creating, defining, and building, and more about helping them to develop those capabilities because once you transition into leadership, it really is about making your team successful.

Often when people are really rockstar individual contributors and they move into leadership, they end up wanting to just do everything rather than teaching their team, training their team, and mentoring their team. Instead, they start doing everything and working themselves to death because that's what success was to them before.

Success was all about, I work as hard as possible. I get everything done. I know I can do it well. But when you get into leadership, you have to step back, let go, teach them, train them, and let them succeed. That's where people I think really struggle. You have to really learn to trust your team, elevate your team, and their success is then what you're rated by.

Mike: That's great. I love that.

Courtney: I have a question. I kind of want to go back to what you were saying a little bit earlier about the software that you developed and you were launching and it was your own initiative. It seems that when people take on similar entrepreneurial endeavors, they have very lofty goals and they want it to be like the next Google or whatnot. Things don't work out directly all the time, I'll say.

It seems that you still consider it a successful endeavor. I was wondering if you could talk to us a little bit about your learning lessons and the outcome from that experience, how you persevered through, and you kept going after the result might not have been what you had expected.

Sue: To be perfectly honest, it's taken me a lot of years to be able to look at that. For a long time, it was devastating. I really believed in it. I felt like it was good for the world. It would help people. It was something that I was really passionate about, but it failed spectacularly from a financial perspective, and it really dampened my desire to try anything like that again.

But I definitely learned you can keep learning and you can keep growing and having a failure like that, it doesn't define you and it doesn't mean that because you couldn't do it then, you're not going to be capable of amazing things in the future. I didn't know what I didn't know.

With the knowledge and the skills that I had at the time, looking back I can say I did really well like that. I'm kind of amazed I got that far considering how much I didn't know. As you grow, progress, and move along in life at the advanced stage, which I have, you really do get perspective. I can look back at that now and I'm really glad that I had that experience because it fostered in me a desire to learn more. I wanted to find out what I was missing and to move on.

At the tech companies, I think I was much more curious about more than just my direct job. I wanted to see what made these other companies successful and to learn about what those gaps were. I think even though I don't have a desire to be an entrepreneur anymore, that curiosity about business, about what made the company successful, I think it helps me in my role today. I won't say that I'm glad I had that failure, but I definitely have a very different perspective on it today than I did then.

Courtney: I think endeavoring into anything like that, you have to be brave. It just shows an incredible amount of bravery on your part and grace that you can look back at it and realize how it's helped you today.

Nancy: I want to add on that too, Sue. I liked how you added more curious and I think that curiosity and that drive, you had the immense drive and that's what really pushed you through.

Sue: I had tremendous financial incentive to recover. I had no choice but to go back to work, which also was really helpful. I think otherwise I might have melted into a little puddle on the floor for a number of years. Sometimes having to push forward to the next thing is the best thing you can do. Just getting back up, putting one foot in front of the other again, and knowing that that's not the end. One failure doesn't define you. It can't define you.

Mike: That's great. There's a book that I love that is called Willing to Fail. It's actually called WTF? but it stands for Willing to Fail. It's by Brian Scudamore who's the founder of 1-800-GOT-JUNK? He talks about all the failures that he encountered in his career. It was probably like the most real kind of conversation. I heard about the book. I heard him in an interview.

I think, like you said, Sue and I would kind of analogize this to my own experience starting Enterey, I didn't really think I was willing to fail at the time. There were plenty of failures that I encountered along the way. But it was more important to keep taking that next step because it was like, okay, this might not be perfect, but I got to keep going. That was kind of the message that I felt back then and I think is true to what Brian Scudamore was saying, which is, you got to try stuff. It may not all work out, but in order to figure out where you want to go, you got to move forward.

Sue: I would say product managers, I mean many roles, but product managers, that is something that they really have to develop. They have to develop a willingness to say, I believe this is the next thing we should do.

For new product managers, that's often really difficult for them to have the confidence to say that or to move into the next role. Often it's hard for people to move from an individual contributor role to a director role where they're responsible for an entire area. They think I'm going to fail. You've got to have the confidence to just step into it.

When they promoted me into this role, I thought oh, I don't know. But you've got to be willing to try and otherwise you're not going to be successful. If you're not willing to fail, you're not going to have the opportunity to fail.

Mike: Hey, Courtney. A lot of our clients we work with have great ideas on how to improve their business, but they just run into challenges that seem to get in the way of accomplishing their goals. Have you ever seen that?

Courtney: Yeah, of course. It happens all the time. I've seen clients struggle with a lack of visibility into all the work that's happening within their organization. I've seen clients that are focused on manual tasks, which takes away from focusing on the actual project work. I've seen leadership struggle to make decisions due to lack of timely information.

Mike: That's so true. It seems like just knowing the problems to fix is only half the battle. How'd you help your clients address those challenges?

Courtney: Well, we of course first work with our client to design a structured management process that fits their culture and team. And in a lot of situations, we bring in tools like Smartsheet to help the entire project team be more efficient. With the help of Smartsheet, we were able to create dashboards, automate routine tasks, and have the information ready in real time to help support leadership's decision-making.

Mike: Wow, it sounds like you not only execute on the project, but your work helps everyone get more done with less work.

Courtney: I hope so. Smartsheet is a powerful tool and my clients seem to be really happy with it.

Mike: That's great. Now, if somebody needs help on their project, what should they do?

Courtney: They should check out enterey.com and schedule a call with us to see how we can help.

Mike: It sounds like a great idea.

Courtney: Well, thank you.

Nancy: Sue, I want to ask. When you first started your journey 21 years ago when you were really searching for something that could be remote or virtual so you could be home with your children or you just had your first child, I think you mentioned, did you ever think that now we'd be in a world where the whole world is remote and virtual. Did you ever think that that was going to happen? Like you came full circle?

Sue: Not at all. I felt so lucky. I felt so fortunate to have found a way to be able to have the best of both worlds in some respects. There's a lot that goes with working from home. For many of us, there's a lot of extra balancing and juggling you have to do, but it is really amazing to see what's changed in the last couple of decades.

Mike: I totally agree. It's a bit crazy. I think if you could have just had a pandemic 21 years ago, you would've been all set.

Sue: I have a couple of PMs who work for me and one of them is about to have her second child, and she's a fantastic worker. Her work ethic is amazing. But it's so interesting as a manager, to be like, of course, go to your appointment. Of course take all the time you need. Of course work whenever you want and realizing it really makes her no less effective at all. How great is it that we can have that kind of flexibility and still have all of the productivity that we have today because of the kinds of tools that we have that allow us to work in that way? It’s really amazing.

Mike: It's amazing just even being on this call and doing what we're doing right now. The technology that got us to this point.

Sue: Absolutely.

Mike: It sounds like, Sue, throughout your journey, building relationships with people has been really critical to your success. I'm just kind of curious about your advice for people who are listening. I can pursue my own dreams and aspirations, but what's critical in terms of dealing with other people and connecting with other people? In your mind, how did that help you get to where you're at?

Sue: For a long time, I really didn't focus on building relationships. I was very much an individual contributor. I do my work. All of my success is based on what I do alone. I had a mentor who essentially said to me listen, you're not going to advance. You're not going to do as well as you could if you won’t really start focusing on building relationships because that is where the true secret sauce is.

In product management in particular, but in business in general, you really need to influence people without having direct authority over them. As a product manager, you're trying to get a lot of people who don't report directly to you to do what you would like them to do and having those relationships is helpful with that.

But it's not just about having them do what you want them to do. It's about understanding them, understanding their needs, understanding their perspectives, and all of those things inform what you're going to do. Having the relationship of trust where they know that you can be counted on to play their role.

It's really important between product and engineering that there's a lot of trust there, product and marketing that there's a lot of trust there. You really want to have those relationships where you are able to work together to accomplish a goal. It also brings a richness to your working life that makes your working life just more satisfactory and helps you to be more effective, I think.

Once I started really working to build those relationships, it became so much easier to accomplish things. It became so much easier and more fun to work and to make all of us successful at the same time.

Mike: I totally agree.

Nancy: That's really like at Enterey, it's a very similar concept. We talk about building relationships with our clients, very similar.

Courtney: I was a science student and a science major all throughout college. I really was always that person who wanted to do everything alone. I wanted to do the lab alone. I wanted to turn the assignment in alone. I did not want to have to deal with anybody else. One of the best pieces of advice that one of my professors gave me was that scientists work together. There is not one scientist who comes upon one concept on their own and develops it from start to finish completely on their own. Scientists work together and so you may not like it, but you need to learn how to work with other people.

It really dawned on me because everything we do in the consulting world or everything, just in business in general, industry-wide, across all industries, you need people in order to get the result you want. It takes an incredible amount of teamwork. I think what you were saying about being able to influence people without having direct authority over them is an excellent skill to have in the business world and as a leader even. Because even if you do have authority over people, you don't want to use the hammer of authority. You want it to be a partnership and a more educational moment. I think that's incredible insight.

Sue: When you are leading people, you need them to feel that they can come to you. You need to have the knowledge and if they aren't willing to share it with you because they don't trust you, because you don't have that relationship, you're going to miss out on critical pieces of knowledge that you need and that's not just the people who report to you. That is the people who are your peers, the people who are above you in the food chain.

You need all of that information. The only way that you get that is by reaching out to people, forming relationships with them, and communicating with them on a regular basis. A lot of the failures that we see in business and in software development have to do with when people stop communicating and when they assume that they know what the other person knows. The more communication you have, the better. The better the relationship you have, the better the communication. It can only benefit, I think.

Courtney: It seems to me that you're somebody who is a lifelong learner and it's not always in a formal setting. There are opportunities to learn around you every day, but you went back to school it seems a little later in your career? Could you tell me about that experience and what it was like to go back to school and then continue your education and continue even more being a lifelong learner.

Sue: Honestly, I think I had a bit of an inferiority complex for a long time because I didn't have my degree. I think I felt like I always needed to work 10 times harder than everyone else in order to prove myself. Even if they didn't have that perception, most people probably didn't even know that I didn't have my degree, but I always felt like I had something to prove.

I've been working in tech for quite some time and I was tired of feeling that way. It was mostly just a personal thing because I'm a huge reader. I'm a huge learner, but it was important to me to get the degree. It was also an important example to set for my teenagers.

I went back, got the degree while I was working, and then once I got that done, I was kind of like why would I stop here? It's time to just get my MBA and move forward. I'm working on that now and it's great. You think you know a lot of things and then you realize how much you don't know as you're taking formal courses. Sometimes it's humbling and sometimes it's really eye-opening, but it's always helpful. I'm just really glad that I've had the opportunity to go back and do that.

Courtney: That's amazing. I am a lover of school as well. I graduated in 2020 with my master's degree. It's funny because KGI keeps having different programs pop up all over and I eyeball them. I'm like oh, that looks fun. That looks so interesting. But then I remember I have to stay focused just for a little bit longer. I sympathize with that. Why stop now? Why not keep going? That's an excellent sentiment.

Nancy: I'm just having a hard time visualizing Courtney, you at any time, not wanting to work with other people. I can't get that out of my head. You said when you were in the science mode, you wanted to do everything yourself. It doesn't equate to the Courtney that we know.

Courtney: I think there's a difference between wanting to work with people who you want to work with versus being told you're working with people who you might not want to work with, would've chosen, or don't have similar motives, I would say. That's one thing I do enjoy about this industry.

Most everybody you meet is like-minded of some sort. You have the same goal and similar backgrounds. You're both in life science, tech, or whatever, for similar reasons. There's a lot more that you can establish in common with other people rather than a freshman course at a university where people don't want to show up prepared or something like that.

Mike: I need to find a way to impart your love of school to our kids. Our kids are both very smart, but I think it's more the age than the philosophy.

Sue: Believe me, I've got four kids and two are in college, one is in high school, and one is in sixth grade. My high school student is giving me a run for my money. I feel you.

Courtney: I was a tutor for a very long time, even up till recently, and one of the things I always told the students who were in high school that I tutored was, it's okay to cry about math. It's okay to cry about science. If you think you're the first person to cry about this or struggle with this, you're wrong because it is hard. This is hard stuff that we're doing, and it doesn't mean it's impossible, but you're right to feel that it's a challenge.

Just saying that a lot of times just kind of flip a switch in their head that they weren't expected to be perfect because yes, it is hard. I mean, who does chemistry for fun on the side? It’s just kind of that mentality that always helped a little bit.

Sue: Actually, my oldest daughter is majoring in computer science and I say that to her all the time. It's supposed to be hard. That's why it's lucrative, it's hard. If it was really easy, everyone would do it. Challenging things are worthwhile.

Mike: Absolutely. I think that's great advice. It is supposed to be hard. It's not easy. What we all do takes talent, energy, and commitment definitely across the board. Sue, I'm curious if there's anything you want to share about where you're headed with products at MasterControl.

Sue: Yeah, I mean, we're at a really exciting point at MasterControl. We have a lot of great products, digital batch record solutions, QMS solutions, and quality event solutions, but we're building our next generation platform, next generation of products that are really data-focused. They're going to have a lot of exciting AI and data capabilities.

That's such a buzzword right now, but what it really means is it's going to give you the next level of understanding about what is happening with your products and your process. Rather than just the software allows you to do the jobs that you need to do and the software stores data as kind of a byproduct of you doing things in the system, instead, it's really about letting us learn from all of that data and then tell you what else can be improved.

Because of what we know about how you operate, because of what we know about the data you put into the system, because of what we know about your manufacturing process, therefore, we can recommend things to you. It's going to be a really exciting time where we are releasing these products to the market that are going to have those capabilities.

Just like I was talking about with dashboards earlier where it really is about what can we help you understand? All of our products really in our whole platform are really going to be focused on what can we help you understand, how can we make you more successful, how can we really help you create life-changing products that are safer in a more efficient way? That is just the goal of our entire product family today.

Mike: That's great. I love it and I love technology when it gives you information that benefits, benefits where you want to go. It's one step ahead, it sounds like, what you're helping keep all your customers one step ahead of where they need to be. That's great.

Nancy: I think it's amazing. I just want to say, when you talked about AI, that we're actually getting to that point. You think of the movies that they made years ago, iRobot and we're actually getting to that point. We just watched The Island the other night. That was another one. It's so futuristic. You mentioned AI that may have that sort of capabilities, that's amazing.

Sue: Hopefully not in a scary way. This will be about supplementing human intelligence and giving you information about what you ought to look into and what you ought to understand rather than taking over. It's amazing to see how far that technology has come.

Mike: It's really cool. I love technology. I love to see kind of where everything is headed, and I'm excited to see what the future holds for MasterControl in that regard. I think we got to move to wrap up here, but I want to hear what you guys thought and what some of your key takeaways were. Before we do that though, I'd really like to play a little game here. Have a little fun. What do you think, Courtney?

Courtney: Yeah, it sounds great. I think we're going to do rapid-fire questions as we have been doing. Mike, I'm going to put you on the spot first today.

Mike: Oh, you're putting me on the spot first.

Courtney: Yeah, so that way Sue and Nancy can see how the game is played and prepare. They're different questions, so I will warn you about that. Don't preselect your answers because I'll ask you something different.

Mike: All right, let's do it. I'm up.

Courtney: Okay. Are you ready?

Mike: Ready.

Courtney: Where did you grow up?

Mike: Seal Beach, California.

Courtney: What is your Hogwarts house?

Mike: I have really no idea, but something about snakes?

Courtney: Slytherin, really?

Mike: Yeah, that's the one.

Courtney: What's your favorite store?

Mike: My favorite store, it's Costco, and that's the exact reason why I no longer have a Costco membership.

Courtney: What was your major in college?

Mike: I was a government major with a second major in computer applications, which was an MIS degree.

Courtney: Cool. Have you ever done a dare that you regret?

Mike: Probably not. I was never much on the dare side of things, but yeah, none that I can think of.

Courtney: What dish do you cook the best?

Mike: What dish do I cook the best? I'll go with waffles.

Courtney: What's your favorite board game?

Mike: The Game of Life.

Courtney: What's your favorite rainy day activity?

Mike: I tend to not worry about the rain, so my favorite rainy day activity is just whatever I would've done otherwise.

Courtney: Okay, and do you enjoy running?

Mike: I did enjoy running. Now my knees hurt too much to enjoy running, but I did enjoy running.

Nancy: Your knee, your feet.

Mike: Yeah, my knees and my feet.

Courtney: Would you ever skydive?

Mike: Oh my goodness, yes.

Nancy: Sue was shaking her head like no way.

Courtney: I would do too. I'm pretty good at withstanding peer pressure. I'm not even pretty good. I'm really good. There's no way to make me do anything ever that I don't want to do. Skydiving is one of them. I've had friends who were, let’s all go skydiving. I'm like I will wait for you on the ground.

Sue: Absolutely not.

Courtney: I can't even handle the Tower of Terror at Disneyland or those drop rides. I don't even go on those.

Nancy: What about bungee jumping?

Courtney: No.

Mike: I say that I would do it because I think if there were ever a time maybe I would do it, but like there are some roller coasters that I've been on recently where it's very breathtaking. Maybe jumping out of a plane wouldn't be the best thing for me to do.

Courtney: It could be safe and people do it all the time, but it's just personal preference I guess.

Nancy: It can go awry. You never know.

Courtney: Nancy, you're up.

Nancy: Oh, okay.

Courtney: What movie do you quote the most?

Nancy: I just did it last night. I would have to say It's a Mad, Mad, Mad, Mad World.

Courtney: Do you like store-bought presents or homemade presents?

Nancy: Homemade.

Courtney: Are you more of an introvert or extrovert?

Nancy: Extrovert.

Courtney: Would you rather have a night out or a night in?

Nancy: Night out.

Courtney: Do you kill bugs you find inside or do you take them outside?

Nancy: No, I'll save them. I try. Even the big gross spiders, I just feel like they serve a purpose. If I feel like my kids were threatened in any way like black widows it's different. That's more a mama bear coming out.

Courtney: They serve their purpose outside. Do you prefer driving or flying?

Nancy: No, I travel so much in both aspects, but I think the open road, driving.

Courtney: Do you think you have more street smarts or book smarts?

Nancy: Street smarts.

Courtney: Fresh food or fried food?

Nancy: Fresh.

Courtney: Are you more cautious or bold?

Nancy: Mike, you want to answer this one for me?

Courtney: Bold.

Mike: Nancy's bold.

Courtney: Do you dip your toe into the pool first and walk slowly or do you cannonball in?

Nancy: I usually cannonball in.

Courtney: What's your go-to karaoke song?

Nancy: Island's in the Stream. I've done that a lot. That's a duet. I have to say that's probably one of them. That and I Got You Babe.

Courtney: Nancy, I've named all of my pets after country music stars. So far I have Bocephus the Cat, Little Willie Nelson, and my new puppy named Dolly Pawton. In the future, if Dolly ever needs a puppy buddy and I mean five years from now, I'm having a really hard time predicting whether I should name him Kenny, Pawter, or Dolly.

Nancy: That will be a hard one. People say that Dolly Pawton, which you brought her to happy hour, was the star of the show, star of the evening.

Courtney: It was so funny. I was so nervous and everybody was like passing me the dog.

Mike: Like a baby. Very cool.

Courtney: Sue, are you ready?

Sue: I guess.

Courtney: What is your last Google search?

Sue: What is my last Google search? MasterControl deviation form example. I was looking for an image to put in a PowerPoint slide. Not very exciting.

Courtney: Which coworker do you message the most?

Sue: Definitely Erin Wright. She is my right-hand woman and we talk constantly all day long.

Courtney: What is your favorite work memory?

Sue: Oh, wow. I think it’s my last company going to Israel with some of my team members. Our headquarters was in Israel and we would travel to Israel frequently. We just had some amazing experiences there when we were tourists. That was a really great work memory.

Courtney: Okay. What's your favorite store?

Sue: Target.

Courtney: What's your favorite holiday?

Sue: Christmas without a doubt. Big sucker for Christmas. Christmas starts in November and it goes until January 15th.

Courtney: Awesome. What is a good spy code name for you?

Sue: The black ninja, I have no idea why.

Courtney: Do you collect anything?

Sue: Books and books and books. My house is like a library.

Courtney: What is your go-to lazy dinner?

Sue: Actually it's not food. We have a term for it at my house, I call it whatever night, and about three times a week, it's whatever night. That means the kids make their own dinner and I am not responsible. I consider that a meal. That's my favorite go-to meal is whatever night.

Courtney: That's awesome.

Nancy: In other words, clean out the fridge night.

Courtney: Who's your favorite Disney character?

Sue: Rapunzel from Tangled.

Courtney: What never fails to make you laugh?

Sue: I laugh all the time. My kids, I'll just say.

Courtney: Do you have a bucket list?

Sue: I do and a lot of it is travel. What is not on there is skydiving, just FYI, not on there. I'd love to travel to almost every continent. It's a long list. It'll take me a long time to get through it.

Courtney: Okay, two more. Which celebrity annoys you the most?

Sue: Oh, wow. Which celebrity? I don't know. Let's do crowd participation. What celebrity annoys you the most because I can't think of one? That's a hard one.

Mike: I can only think of like the Kardashians or something like that.

Courtney: I was going to say that. This is controversial, but Tom Brady, I'm tired of it. I'm sorry, Nancy. Okay, then last question. Cats or dogs?

Sue: Dogs. I love cats, but I'm super allergic to them. The last time that I sat and the last time I was petting a cat, I ended up in the hospital with my throat closed off. Dogs for sure.

Mike: I'm on the exact same page as you, Sue. I want to scratch myself from the inside out.

Sue: Not comfortable.

Mike: That's awesome. That was fantastic. I love that, Courtney. Thank you so much for leading us through that. Now let's move on. I want to know what you guys took away from our conversation with Sue. Sue, thank you so much for sharing all your insights.

Sue: Thanks for having me.

Mike: Courtney, how about an insight or two?

Courtney: I really noticed throughout our conversation with Sue, her incredible amount of tenacity driven by the passion for the things that she loves to do and her curiosity to find out more. I think that that's an incredible quality to have in a leader, somebody who just enjoys doing what they do and who's tenacious throughout their career path to get to where they are. I think it's an incredible characteristic as a role model and a leader.

I think also, she touched on it, but the amount of creativity needed in order to be successful in a role as a product manager seems immense because you have to constantly find solutions that might not be concrete answers to solve problems for customers. I think that's an incredible quality also that Sue has demonstrated throughout our conversation today and from her past as well.

Sue: Oh, thank you.

Mike: How about you, Nancy? What did you think?

Nancy: Listening to you Sue, the one thing that got me is the one thing that you said kind of in the beginning. With all the fancy words and all the tools that use, and like you said, the creativity, the drive, the curiosity, all of that, but it really stems down—I actually wrote it down—that if it's as simple as helping people make sense of all of their data.

That to me just helped put everything together because I was actually one of those people. I really wasn't exactly sure what you did. I see your title, I know what that means, but just when you put it into those terms and just simplify everything, I just thought that was a really good way of keeping it simple and explaining it.

Sue: Oh, thank you.

Mike: Awesome. From my perspective, I really enjoyed our conversation and I'm going to go a little off-script here. It’s not so much something you said, but kind of how you said it, Sue, I really appreciated the honesty and kind of transparency that you displayed in the conversation. Just as an example, just to tell us straight up, hey, it really wasn't the best experience when I had that major issue with the software company.

Just being totally open and honest, I think that feeds into all of our daily lives. The more we can be open and transparent and honest with people, I think the better outcomes we have. Regardless of whether it's a good story or not, it's the truth and it's kind of the experience and what you've lived by. Thank you for that.

I think that was a really great way to share your experience and we were very pleased and very thankful to have you on the show. Thanks so much for joining us. Hopefully we'll talk again soon.

What does it mean to be a lifelong learner, and how can you do it? How does it benefit you? Today’s guest, Sam Howard, explains what it means to him to be a lifelong learner and how he does it. 

Sam Howard was previously a managing consultant for Enterey. Today, he’s a Senior Program Manager at Dendreon. In today’s interview, he discusses his career, going back to his days in the military and how he transitioned from that to life sciences. He also talks about whether leaders are born or made, the difference between managers and leaders, and how he recommends getting more reading time in.

• How Sam decided on a military career coming out of school
• Correlations between Sam’s scientific training and military work
• Whether leadership is innate or something that can be fostered
• The difference between managing and leading
• How Sam adapted to different leaders he had to work for or follow
• Who influenced Sam’s development as a leader
• One minimally viable self-improvement thing that can be done daily
• The best books Sam has read
• How to get more reading time in
• Sam’s networking strategies
•  

Today, we have a very special guest. Sam Howard is with us. All right, let's just jump into our discussion with Sam.

Sam Howard is currently the Senior Program Manager at Dendreon Seal Beach Manufacturing Facility. He has a comprehensive background in leadership, supply chain management, and project management. Prior to entering the business world, Sam spent over 28 years serving our country in the United States Marine Corps. Thank you, Sam. He retired as Lieutenant Colonel.

During his time in the Marines, Sam held multiple logistics roles where he focused on operationalizing logistics and support of [...] security operations. He also performed a critical role back here at home in the recruitment of New Marines where he led operations and support of the successful transition of more than 33,000 recruits and their transition from civilian to a basically trained marine. Talk about a recruiting effort, Sam. That's pretty darn impressive.

After his retirement from the Marine Corps, Sam joined Enterey Life Sciences Consulting, which is a company we know a little bit about. He did that to pursue his interest in the life sciences industry. This interest was originally developed as Sam earns his degree in Biology from the University of North Carolina at Greensboro.

After serving as a Manager at Enterey for nearly three years, Sam has taken a role at Dendreon. A company founded in the belief that immunotherapy made from a patient's own cells will transform cancer treatment. Sam is supporting Dendreon's efforts to expand their contract manufacturing capability in the fast-growing personalized medicine space.

Without further ado, I like to welcome Sam to the podcast. Welcome, Sam. We're looking forward to talking to you.

Sam: Thank you, Mike and Courtney. It was quite an introduction. I'm not sure I'm worthy of all of those nice accolades. But I will like to say, in all of those efforts, I was never alone. It was always a team effort. That has allowed me to achieve and basically enjoy a lot of successes I've had throughout my career in life. Thank you.

Mike: You're welcome. It's great to have you and certainly knowing you from your work here at Enterey, we acknowledge and recognize these accomplishments there. Let's jump right in. My first question is one that maybe a lot of people wonder about. Coming out of school as a Biology major, how did you decide to embark on a military career as opposed to something like med school or some other scientific career that maybe some of your peer students were focused on?

Sam: Mike, that's a great question. When I've had the answer on numerous occasions, yes, absolutely. Because people have asked, wait a minute, you were a Marine, and now you're in life sciences. How and why? I guess to fill in some of the story, I had to go back to my basic understanding as a sophomore and a junior in college. I'm going through taking classes, attending labs. Along the way, I think I mustered up the courage to ask one of my counselors, what am I going to do with this degree? They laid on a couple of options. One was to obviously work in the lab. I'm like, okay, by yourself, seems very repetitive. I don't know if that's something that's going to appeal to me.

The other one was pharmaceutical sales. I'm like, yikes, no way. I am not cut out to be a salesperson. What do I even know about talking to people about different activities? I really started thinking about what am I going to do going forward. Obviously, I'm going to complete my program. I'm going to pursue something. As a professional, what do I want to do?

Along that time, the Marine Corps came up and gave me some options. One of them was, hey, why don't you get your degree and come and actually lead marines. I said, that's interesting. They taught me about being a platoon commander and what it actually means to serve your country. The opportunities you have to travel and to grow as a professional. I was like, that sounds very appealing. I think I would like to see if I can climb out to the challenge of actually leading marines in a very dynamic and obviously, in some cases, kinetic environment.

I chose to do that fully thinking that I wasn't going to go do it for four years and come right back. Somehow 40 years moved on and next thing you know, it was a career, I was enjoying it, and I decided to continue to go until I couldn't go anymore. After that, wrapping that up, I came back and said, now what do I want to do? I remember what I liked about the challenges of the Marine Corps which was, can you lead people? Yes, I love leading people. Can you work and solve complex problems? Yes, I can do that. I love doing that. Can I make a difference?

I realize those are three things that really drive me as a person, as a professional. I was like, whatever I'm going to do in my next career, I want to be able to lead people, I want to be able to solve complex problems, and I want to be able to make a difference. I started looking out my search and along the way, surprise, surprise, I stumbled back into life sciences. The opportunity was there for me to be able to lead people, again, solve—obviously—some complex problems, and to really make a difference. That really appealed to my core.

At the heart of my upbringing was always that scientific curiosity. It has checked all the boxes. I came back and said, yes, I would love to be a member of the life sciences community. I started my networking, how do I actually get back in, and along the way, again, you walk in and you never know who you run into. I ran into some great former armed services members who really talked to me and encouraged me to look outside and develop those contacts.

All of a sudden, one day, I ran to this person called Ryan Coughlin. I'm like, wait a minute, Ryan Coughlin. He's a Marine and he works at this company called Enterey. "Hey Ryan, I'm a Marine. I want to get into life sciences. Let's talk about Enterey."

Before you know it, I was with Enterey actually working with some great people, trying to come up and solve complex problems, and in the end, making a difference in people and patients' lives.

Mike: I love that story. That's great.

Courtney: Yeah. It's amazing.

Mike: Really good journey from military to getting back into the industry. As you mentioned your leadership experiences, this podcast is about leadership. I think you may have learned some things in your educational experience in the biology side that may have given you some structure for being a leader in the Marines and then applying that back to the industry. I'm just curious if there are some correlations that you recall from that time.

Sam: Absolutely. At the heart of it, again, I'm going to use the word scientific process. You want to actually do something. You want to observe and then make changes. I found that approach to line up perfectly, again, with my values and beliefs. The way that I was able to use that structure in the military, for me, was pretty straightforward.

If I was given a task, an opportunity to lead a particular mission or work and develop a solution with people, I always stepped up with that. Say, here is what I think we want to be able to do. Let's make sure we understand what it is we're going to do, and then let's start taking some appropriate actions and see if those results line up to what we want to have occur.

For me, the transition, I will say, wasn't always natural because there were some elements that require a little more hands-on approach, meaning communication. Obviously, I had to deal with a lot more people, a lot more dynamic and fluid than in some cases because of just the geographic of the area that we worked in and in some cases the nature, the mission that we were assigned.

But in the end, having that approach and understanding that yes, there is a cause and reaction to your activities allowed me to really develop and key in, as a leader, how I'm able to help shape the activities and the outcome for my mission and more importantly for the people that I was assigned to lead. Definitely correlated.

Courtney: Yeah. It seems that leadership is innate with you and that's what drew you to the Marines, was the leadership aspect. My question for you would be, do you think our leaders are born innately made or do you think leadership can be fostered and developed within people?

Sam: That's a great question, Courtney. Again, I wanted to be honest that we've been asked to ponder on numerous occasions. Are leaders born or are leaders made? Again, my personal belief is it's the combination. Yes, you are born with some innate skills and capabilities. I think it's incumbent upon you to help develop and refine those skills to develop that leadership skills. I've never met anybody that was a perfect leader. No one. Maybe there is one or two that exist, but to be honest, I've never encountered them.

Along the way, the people that I admire as leaders, for one, were humble. They were willing to say, hey, I don't know everything. They had the courage, in some cases, to say I don't know. They definitely look and sought out opportunities to help develop and refine those skills. When they notice that there was a gap in their ability to execute or maybe a gap in their knowledge, they didn't let that hinder them. They decided to take action. To me, that's the very definition of a leader. It's not knowing the answer, but being willing and able to actually come up with a solution to solve it. That's the difference as a leader.

Courtney: Yeah, that's amazing. I know that a lot of these life science companies really rely on their management teams to help drive their employees and drive their personnel toward their end goal, which oftentimes is getting medicine to patients. What do you think is the difference between somebody who's just a manager and somebody who is a leader to drive folks towards that goal?

Sam: That's a great question. Again, something that I've been able to actually walk through with members of my project team, and on occasion, I actually talk to our senior leadership about as members of this journey committee. It's never a really straightforward and simple answer. But the way I [...] is leaders actually come up with visions. They have a vision. They don't know the answer but they have a vision. I think managers often develop into giving that task and managing a list.

In the Marine Corps, we despise the word manager. If you said you were a manager, you're a persona non grata. We would often say, you manage things but you lead people. In the end, that concept has a ring of truth to it. Yes, as a manager, I've seen them develop into here's a series of actions, steps, and tasks that need to be accomplished.

As a leader, yes, I'm not saying those things are important, but in the end, they are worried about hey, is this vision going to be able to succeed and thrive? Do I have the right people and employees to make that happen? And then they come up and create opportunities for those people to actually eventually satisfy or more importantly, accomplish that vision. To me, that's the difference between being a manager and a leader.

Mike: That's great. I really love the distinction you made there. One thing that always strikes me is that people that you work for, you may not get to choose that. Therefore, you have many different styles of leadership that you have to follow. I'm sure that you encountered that a lot in your time with the Marines and beyond. I'm curious, tell me your thoughts on how did you adapt to the different leaders that you had to work for or follow, and were there times when you didn't adapt?

Sam: The short answer is yes. There are definitely times that I could have done things much better, and yes, to me, leadership is not always straightforward. There are many different paths to the same outcome. Basically, at this point in my life, I've stumbled upon the fact that I can't necessarily control the outcome. But I can control my own actions and my own beliefs. In the end, the way that I've always approached this, I'm going to be consistent, I'm going to be transparent, and I'm going to give you my opinion as we go forward.

That has worked for me going forward. But again, that wasn't always the case when I was younger. When I was younger, it was hey, this is how we're going to do it and I was born and willing to challenge saying, why are we going to do it this way? Again, as I've gone through this—I call it a maturation process—I realize that my way is not necessarily the best way. My way is a way, but there may be a better way.

As a leader, going back to being that leader, sometimes and a lot of times, you need to listen and actually learn and say, hey, why do you want to do it that way? One of the great things that I tried to help develop especially as I've talked about leadership and develop my own leaders is, we have to ask key questions. Questions that really revolve around how are we going to solve this. I used to tell my Marines and I tell my consultants going forward, the question of how as opposed to why. Asking that how question allows people to really give an honest answer and it doesn't necessarily make them defensive about a position that they may hold.

I really learned as a leader going forward is I like to ask the how questions as opposed to the why are we doing something. That had made a big difference going forward. The how questions paired up with my own opportunity to listen, learn, and realize that my way is not necessarily the best way has allowed me to be more successful and definitely allowed me to realize there are many different leaders, different ways to all see the objectives. Just because I don't necessarily subscribe to that approach doesn't mean it's wrong.

Courtney: I think that's critical. What you mentioned, knowing that it doesn't have to be your way, it just has to be the way that gets the team there. Maintaining that state of open-mindedness as a leader is incredibly admirable and is most certainly somebody that I would want to work for. Thank you, Sam.

Mike: I was just going to ask you, Sam. It's always great to learn from others too. I imagine you learned from others along the way. Is there anybody in particular that you recall that had a particular influence on your development as a leader, as a person, however you'd like to approach that?

Sam: As a person, at least for me, I could always go back to looking at who were influential role models in my life. I'm going to start, obviously, my dad. My dad was and is a retired Marine. Clearly, that had a big bearing in what I wanted to do going forward because I saw him live out his values and live and display his integrity going forward. That's something that I always admired.

I admired it because no matter what the situation was, he always had a sense of what was right and what was wrong. He was willing and had the courage to actually speak up for what he thought was right. Even though it may not necessarily be popular, even though he may have been the minority in the group. But you always knew what my dad stood. When I saw that going forward, I wanted to emulate that. I want to be that person.

As I went throughout my career, there are a lot of people that I could probably bring up as great examples. A lot of them, to be honest, were enlisted members. I'm supposed to be, as an officer, you often thought of it as the leader. You're the guy who's actually making the decisions and actually driving the organization. To be honest, there are a lot of times when that was not even close to being the case. Some of them were my senior enlisted advisors.

I remember one in particular who had when I just took over as a new company commander, I was really excited to be able to actually drive and actually take charge and be held responsible. I remember having those discussions with my first sergeant coronel at the time. He'd been walking in my office and not that he would challenge me, but he would ask me. "So, sir, is that really what you want to do? Do you really think that's the best path forward for the Marines?"

I always appreciated that he never necessarily said I was wrong, but he always coming up to me to think about what it is that we needed to do and [...] those terms so that I had a better appreciation. He taught me, again, how to be honest, how to be respectful, and more importantly, how to take the interest of the Marines. Those lessons I carry forward going throughout my career.

I remember, again, in the same organization, I ran into, at the time, Major Burn, he was our executive officer. He asked me, he says, Sam, what do you want to do in your career? I thought, what do you mean? I'm a Marine officer. That is my career. I'm doing it. He was like, okay, yes, you are a Marine officer, but that's not necessarily your career path. What is it that you want to do?

I remember he made me actually think about what is it I wanted to do. From that point kind of start shaping my actions and more importantly my decisions to do that. Then he taught me the importance of having a vision. Not only in your professional life but applying that same vision, those same aspects toward your personal life. For me, at that time, I was a young officer, impressionable. That to me, it was life-changing. I took responsibility for my actions and my decisions and I realized that it had a larger impact on the direction and more importantly my actions in the future. I definitely appreciate that.

And then, the last person that we're bringing up is my current boss, Maria Choi out of Dendreon. The reason why I admire her as a leader is because she has the passion, the foresight, and the knowledge that actually drives the actions. She is not willing to take a no for an answer, but she will challenge you on any nos.

I love the aspect of her being, for one, challenging people's decisions, and then more importantly, creating that vision for us to follow. Because of her passion and because of her vision, it makes working for her so much easier. Because I realize that even if I make a mistake, as long as I'm working toward the goal and the vision you have, I'm going to be okay, and the organization is going to be okay.

She taught me that it's okay to make mistakes and to not necessarily be perfect. As long as you have the best intent in mind and that you actually try and accomplish the vision, whatever you come up with is going to be acceptable. Those three people, I guess, looking at my career and my time, really had an influence and they help shape my values and my beliefs. Again, my appreciation for what it means to be a great leader.

Mike: Awesome. All three are just great examples, great reasons why. That hit me. I wrote down some notes for myself listening to you speak. I think those are great examples of what people can do to help inspire others. You living those things in your work and life and take what you've learned from people to help others grow as well. I really appreciate that insight.

Hey, Courtney. A lot of our clients we work with have great ideas on how to improve their business. But they just run into challenges that seem to get in the way of accomplishing their goals. Have you ever seen that?

Courtney: Yeah, of course. It happens all the time. I've seen clients struggle with a lack of visibility into all the work that's happening within their organization. I've seen clients that are focused on manual tasks, which takes away from focusing on the actual project work. And I've seen leadership struggle to make decisions to the lack of timely information.

Mike: That's so true. It seems like just knowing the problems to fix is only half the battle. How'd you help your clients address those challenges?

Courtney: Well, we of course first work with our client to design a structured management process that fits their culture and team. And in a lot of situations, we bring in tools like Smartsheet to help the entire project team be more efficient. With the help of Smartsheet, we were able to create dashboards, automate routine tasks, and have the information ready in real time to help support leadership's decision-making.

Mike: Wow. It sounds like you're not only executing the project, but your work helps everyone get more done with less work.

Courtney: I hope so. Smartsheet is a powerful tool and my clients seem to be really happy with it.

Mike: That's great. If somebody needs help on their project, what should they do?

Courtney: They should check out enterey.com and schedule a call with us to see how we can help.

Mike: Sounds like a great idea.

Courtney: Well, thank you.

Mike: In talking about the leaders that you just described, a lot of it, what you took from it was just getting better a little bit each time. Not worried about making mistakes, but trying to get better and focusing on learning and growth. One question we'd have is, what is one minimally viable thing that you can do each day to make yourself better on an ongoing basis?

Sam: To me, it's reading. It's just reading. The great thing about, to me, I'm going to say the internet is there are these limitless opportunities for you to pause and actually learn more about a particular topic, maybe a particular concept, that you really maybe never even encountered before.

Again, going back to my days in the military, we were given opportunities to actually go study. We would be selected to go spend a year, actually learning our craft and learning how we could apply the principles of warfighting. I remember we had a class one time and one of the professors challenges us to be lifelong learners. At the time, I was like, lifelong learners? Okay. At the time, I'm young. That didn't really sink in, but it was amazing.

As I start thinking about it more and more, I'm like, yes, how else can you possibly lead and continue to get the best out of people if you, yourself, never evolve? To me, there's the ability to read. Again, not that I don't care what the topic are because topics I think are important. But I think just committing to the idea that I am going to read something new every day, maybe it's about the industry, maybe it's about your favorite sport. But just committing to that aspect will allow you to develop those habits that I think are very important as a leader and as a member of this life sciences industry.

Which is you got to be that lifelong learner because things change. We're living in the process right now at Dendreon where things are changing for us. We have to be able to understand what are the new concepts, what are the new things happening inside the industry, and how can we actually help foster and build that idea to get it to, again, our patients.

That won't happen if we are just concentrating on the day-to-day activities, worried about meeting timelines, filling out spreadsheets, and attending meetings. You have to pause and be able to read. Again, having that natural curiosity and committing to be that lifelong learner will allow that.

Mike: That's awesome. Totally agree.

Courtney: I was going to say, I see you have a bookshelf behind you. For our listeners at home who can't see, Sam is sitting at his desk with a bookshelf full of books and photos in a stormtrooper hat. But based off of that other question, what are some of the best books you've read?

Sam: Let's see. The best books I've read, there's, again, sci-fi is definitely one of my favorite. Doom is a great series. I got to go back to Doom. I love the Doom series. I think I try to re-read each book probably multiple times. I love that as both a genre and just topics. Just concepts of trying to understand the underlying things. Religion for example in Doom.

I guess one of the great books that I just—let me pull back and look at it. I just finished reading Jobs To Be Done. It talks about theory to practice of how do you actually come up with this concept, how do you actually understand what needs to occur. More importantly, how do you actually get it done. Again, in the author's words, "How to actually put some things in practice from idea into execution."

I've actually used part of this book in my discussions with some of my student committee, and again, members of the project team just to make sure they understand the concept. Because I'm a big believer in if you understand the concept, then the actions, and the tasks, I don't need to direct all of that stuff. Because you'll use your own initiative and your own abilities to come up with a solution that, to be honest, it's probably 10 times better than I could ever think of. All I need to do is get you to understand the concept.

Books that allow me to understand the concepts and actually understand how to put those in practice, that's really what I cater toward. I just finished another book. I love this book, Team Genius. It is funny because one of the notions of what does it take for the ideal team. The author concedes that the idea of team consists of five plus or minus two people. It's like either seven or three people.

It's funny because I use that when I started talking to my student saying, you know what, we got too many people in here. We're not able to effectively make decisions, we're not communicating correctly. And I refer them back to that book saying, scientifically speaking—again, going back to my data backdrop—ideal team consists of this.

That argument allowed me to actually facilitate a restructuring of our project team so we could make better decisions. Again, I like to combine all those different actions, but in the end, using books to understand concept and idea, to me, is critically important and that's a marker of a true professional. Can you imagine your doctor not reading and keeping up with what's going on?

Courtney: That would be terrifying.

Sam: I would be terrified as well. As you should be. To me, as a market professional, yes, you should have some books. You should be able to understand some concepts. Again, to me, that's the kind of books and that's where I evolve into.

Mike: I love to buy books. I've not done as good job of reading all of those books. My wife will tell you, I'll order a book, a new book will arrive at home, and I have every intent to read it. But it goes on to a stack of books that I haven't read. This is a practical question. What's your best advice for getting more reading time in?

Sam: You got to put it on your calendar. I hate to say it, but we're all kind of driven. We are conditioned to understand and work within a calendar. In a way that I approach this, you schedule the things that are important to you. If you schedule things that are important to you, then all of a sudden it becomes something that you're going to follow up and act on.

Even the idea of reading, going back to my military time, we had another professor walk in, he threw out this concept of speed reading. I'm like, what is speed reading? What are you talking about? He laid out this notion that, do you need to know every word in the book to understand the concept? He challenged me to say, no, of course not.

He said, the author is really good and the author is going to basically lay out his idea, he's going to lay out supporting arguments for his idea, and then he's going to conclude by repeating what his idea was. He said, for you, as a reader, that's what you want to understand. Because the rest are just examples. He said, but do you understand the concept?

I go back to, do I understand the concept that's been poured out inside the book. Because I'm going to have my own stories. Maybe I need to know one or two, but do I need to know all those stories, maybe, maybe not. But to me, the first step is just scheduling the time.

The second one is, make sure you understand what you're reading for. For me, a lot of the time, I'm reading to understand the concept. What is the concept they're trying to offer so I can take and apply using my knowledge, training, and experience, and to action with my team members.

Mike: That's great advice and I think a really good point. I know when I was doing a good job of reading and getting through my list of books. I was just dedicating a small amount of time, even just 15 minutes, 20 minutes a day and that makes a big difference too.

Sam: Yeah, absolutely.

Mike: Love it. One thing, Sam, I know you're really good at is networking. I saw you network effectively when you're here at Enterey and just curious what your tips are from a networking standpoint and how do you go about meeting others in a leadership capacity or to learn more? What are your strategies there?

Sam: You're being way too kind. I don't know if I'm good at networking. I'm just okay with people saying no. Maybe there's a slight distinction. The first thing I learned was you have to be comfortable with putting yourself out there. That's the first step. If you're waiting for someone to walk up to you then you've already lost the battle. You might as well go home. There were lots of opportunities to develop that and then I started realizing, why do I walk up and talk to some people? Why do some people hold my interest and certain people don't?

I started thinking about what I liked when I interact with new people. I started to try to model and actually show that. To me, the first step is, you can call it elevator pitch and that's fine. Why are we talking? What do you want to talk about? Just understanding and being very succinct about it. Understanding what is going to interest them and being able to encapsulate that in three to four sentences to me is always key.

I've always tried to make sure that I understood the environment, make sure I understood what I thought that particular member wanted to understand or get from me, and then try to actually develop that. Going through that and a lot of practice, I still don't think I'm very good at it, but just practicing and actually walking up, just talking to people, and being genuine about who I am, what do I want to do. Because what I found is that people, at their heart, they want to help.

If you tell them what you want to do, they'll think about how can I help you. It's amazing, next thing you're having the conversation about what it is that you want to do and how you can help them. In the end, to me, you develop that connection. To me, networking is about developing that connection. You're not necessarily going to solve all the problems and nor do you want to solve all their problems in your networking encounter. But you do want to leave up the opportunity that hey look, I'm interested in trying to see what I can do to help you. Normally, they will correspond and communicate the same to you.

Mike: Very good advice. All right, Sam, that was great. I think we're going to head into wrap up here. But before we do, we'd like to play a little game in our podcast here. Have a little fun, I should say. Courtney, I'm going to turn over to you. I think you're going to do a little speed round of questions.

Courtney: Yeah, thanks Mike. Yes, I do have questions. They are for fun. Whatever the first thing that pops in your head is fine. If you want to pass a question, just say pass and let me know. I will ask Sam about 10 questions, then it'll be Mike's turn, and then we'll say goodbye unfortunately too soon. Sam, you are up first. Are you ready?

Sam: I am ready. I'm leaning forward to my seat.

Courtney: Okay. On your mark, get set, go. What has been your favorite age so far?

Sam: Twenty-five.

Courtney: What's your go to lazy dinner?

Sam: Spaghetti.

Courtney: What is your favorite thing to do in the summertime?

Sam: Play basketball.

Courtney: What is one of your nicknames?

Sam: I may need to pass on that one.

Courtney: What movie do you enjoy quoting the most?

Sam: Star Wars.

Courtney: If you could be transformed into one animal, which one would you choose?

Sam: One animal, I don't know if I could pick one animal. I don't know. I get more pass on that one because I don't have one animal.

Courtney: What dish do you cook the best?

Sam: I get the grill so I'm going to say anything that I can grill, I normally do a decent job on. Steak and chicken.

Courtney: What story do you tell the most often?

Sam: The story that I tell the most often. Does it have to be true or just?

Courtney: No.

Sam: Story I tell the most often. This is definitely for my children. I tell my children the story about the three rules because there were three rules that we had that I've given them as they're growing up. We always review and go back to that story about what are three rules that I abide by.

Courtney: Very cool. And what is your hidden talent?

Sam: Oh man, hidden talent. I could be extremely quiet. I don't know if I have a hidden talent. That would imply that I have some talent. I don't know if I have one.

Courtney: I would say that being quiet is a talent of yours because it's normally not good when you're super quiet. It's scary but effective.

Sam: Yes, thank you. I'm going to stick with being quiet because as you know, I'm definitely going to pay you [...] everything. If I think there's an opening, normally, I'm willing to share. I do practice and try to be quiet.

Courtney: Very cool. Thank you, Sam. That wraps up your turn. Mike Ferletic, I'm looking at you next.

Mike: All right.

Courtney: Are you ready?

Mike: I am ready. I just have to say, based on your Star Wars answer, that explains the stormtrooper there, Sam.

Sam: It's funny because on both shelves, there's some hidden meaning about anything on my shelf. Anything that's on the shelves behind me typically is a gift. My family knows that I love Star Wars. It seems like every year for my birthday or for Christmas, they will buy me something. In this case, the bought the stormtrooper bank, which I adore so it's on the shelf. Anything that you give me goes on the shelf.

Courtney: Your dog is named Princess Leia's Spiderman, right?

Sam: It is. That is her name. Leia's Spiderman.

Courtney: For our listeners out there, Sam used to be my direct manager when he was here at Enterey, so that's how I know all about the Star Wars jokes and the dog's name.

Mike: Awesome.

Courtney: Are you ready, Mike?

Mike: I'm ready.

Courtney: Okay. What's your favorite board game?

Mike: I love Monopoly. Actually, I'll change. I like the Game of Life.

Courtney: Okay. How do you usually answer the telephone?

Mike: Hi, this is Mike.

Courtney: Who is your favorite Disney character?

Mike: Sheriff Woody.

Courtney: What are you most looking forward to?

Mike: What am I most looking forward to? Just in general right now? I'm really looking forward to a little time off between the holidays. It's going to be nice to wrap up the year and get recharged for 2022.

Courtney: Very cool. What never fails to make you laugh?

Mike: Our dog had her teeth removed—one of our dogs. That in itself is not funny, but the poor thing can no longer keep her tongue in her mouth so it sticks out to the side. No matter how often you see it, it makes you chuckle every time.

Courtney: That's so funny. If you were to write a book, what would it be about?

Mike: If I were to write a book, what would it be about? It would be about somebody that accomplishes great things but is different from the rest of the pack, so to speak. Someone that is not meant to be in a certain arena, but they thrive in that space.

Courtney: Nice. If you had to change your first name, what would you change it to?

Mike: Oh, wow. Don't ask me why, but it is because it's my son's name. But I would say John. My son's name is John but he doesn't go by John, he goes by Jack. I could still take John and would not affect his name.

Courtney: Nice. What is your favorite type of weather?

Mike: I like it a bit cold and I like bouts of snow, but I like to visit the snow and then I would like to come back nice, temperate between 75 and 85.

Courtney: What is your favorite store?

Mike: My favorite store? I will say my favorite store is Costco and it's precisely why I no longer have a Costco membership.

Courtney: Understandable.

Mike: We could not go in there without spending a lot of money. Every time.

Courtney: Fair. Last question, what would your spy codename be?

Mike: My spy codename? Interesting. My spy codename should be something that you wouldn't be able to identify me with, but I can't think of what that would be.

Courtney: It wouldn't be Mike Ferletic?

Mike: No, it wouldn't be Mike Ferletic. But in highschool, they call me Mr. Furly because Ferletic, Furly. I have to go way back to a show called Three's Company. I'm sure Sam knows it. Courtney, I'm not sure if you've seen that show.

Sam: Don Knotts, yes.

Mike: Yeah, that's right.

Courtney: Awesome. That wraps up our speed question game.

Mike: That was fun.

Courtney: Thank you both for playing along. It was fun to learn about your thoughts and the answers to some of them.

Mike: Thanks for putting it out together, Courtney.

Courtney: Of course, no problem.

Mike: And Sam, I have to tell you, I know it's the middle of the afternoon here. But tonight at Honda Center, the Ducks are hosting Star Wars night if you're a hockey fan. You might need to head north.

Sam: I guess that I am a sucker for anything and everything Star Wars. I will definitely look into that. Attending a hockey game is definitely on my short list of things to do. We didn't get a chance to do that in some other places that we've lived. It'd be really cool to see a different sport. I'm looking forward to that.

Courtney: In the spirit of leadership and asking clarifying questions, what is Star Wars?

Mike: I'm not even sure I know how to answer.

Courtney: I wish everybody could see Sam's face. It just dropped and he got real quiet.

Sam: That's [...] how do you remove from the building.

Mike: I'm not even a huge fan.

Courtney: I'm just teasing everybody.

Mike: That's great. That's so funny. All right. Awesome. We're going to wrap up this episode of the Leaders in Life Sciences podcast. Thank you Sam Howard for joining us. We wish you nothing but the best and thank you again for your 28 years of service to our country. Always admire that and once a Marine, always a Marine, right? Thank you for your ongoing commitment to our country and serving all of us in the time that you did.

How does a woman in a male-dominated military field develop a leadership voice, and how does that translate to corporate work? You’ll learn more during today’s interview with Harriet Johnson.

Harriet earned a Navy scholarship to afford school outside of her home state of Georgia. She went to Tufts University in Boston, Massachusetts, then went on to active duty in the Navy for 12 years as a helicopter pilot and staff officer, and then served an additional 5 years as a reserve officer. She's been in pharma now for over eight years, mostly in manufacturing at large- and medium-sized companies.

Listen to the episode to learn more about how she made it through difficult experiences, how military leadership translates to her current work life, and a bit about Harriet's personal experiences through this time.

• Harriet’s background and how she got to this point in her career
• Harriet's many destinations throughout her life
• Harriet’s time as a female helicopter pilot of a Seahawk helicopter
• Harriet’s challenges in finding her way in the tactical squadron
• How Harriet found her leadership voice as a pilot
• How Harriet kept her head up through difficult experiences
• A decision Harriet wishes she hadn’t made
• What leadership was like in the military, and how that leadership translates to her home and work life now
• The differences between a military experience and a corporate experience
• Harriet’s callsign
• Ideas for someone who's growing in their career
•  

Our guest today is Harriet Johnson. She is a manager here at Enterey, been with us roughly one year, right Harriet?

Harriet: I have, thanks. Thanks for having me.

Mike: I've had the distinct pleasure of working with Harriet pretty closely over the last year. She's been doing great work with the client that she's been serving. Harriet is a veteran of the US Navy. As you'll learn, she earned her Navy RTC scholarship to afford school outside of her home state of Georgia. She went to Tufts University in Boston, Massachusetts. I think they are the Jumbos, right, Harriet?

Harriet: That is correct. Go Jumbos.

Mike: How would I know that? After Tufts, she did move on to active duty in the Navy for 12 years as a helicopter pilot and staff officer, and then served an additional 5 years as a reserve officer. She's been in pharma now for over seven years, and seen a breadth of operations mostly in manufacturing at large- and medium-sized companies.

Some examples of what she was involved in was she was a shop floor supervisor for a labeling line and also a supply chain planner for a product launch into various X US markets. She lives with a continuous improvement mindset and service orientation. She also lives with four kids and a husband.

She has launched two corporate-wide technology platforms to support internal training initiatives. She enjoys consulting, because home for her is where I can help the people who do the work be more successful. Most recently, she has helped multiple clients internally unify to formalize policies and procedures.

In her spare time, Harriet enjoys crafting and having adventures with friends. I am really looking forward to learning more about Harriet and hearing more about her experience with different leaders and her own leadership journey. Without further delay, let's say hello to one of Tufts University's Jumbo’s finest alumni, Harriet Johnson. Welcome, Harriet.

Harriet: Thank you so much for having me. I'm excited to be here.

Mike: Thank you. It's great to have you. We always like to start the podcast just by asking our guests a little bit about you, and how did you get to this point in your career?

Harriet: I left the military and locked into this fantastic program at Merck called the Manufacturing Leadership Development Program. That gave me a nice breadth of understanding of what the pharmaceutical industry is all about. I started in the sterile liquids pilot plant and did a rotation there. I got my green belt while I was at it because I had done all of the training when I was in the military, but didn't understand the value of the piece of paper.

This was my first opportunity to actually like, all right, let's get it documented, because as we all know, in pharma, if it's not documented, it didn't happen. I got my green belt there, and then I went on and did a packaging rotation, and then I also did a supply chain planter rotation. Then I joined their continuous improvement shop at Merck, and that was really exciting.

During that time, my husband got a job in the San Francisco Bay area. We were living in Pennsylvania at the time. He found his dream job here in the Bay Area. Merck was amazingly gracious and let me work remote, and that was great.

I'm also an extreme extrovert. At the time, it just wasn't working for me after a little bit of time. I found a local job and a similar continuous improvement role, and then the pandemic hit. As we mentioned before, my husband, we were college sweethearts. He followed me on the military journey, and gave up and took his career backseat on multiple occasions in service of our nation.

When the pandemic hit and something had to give, and our four beautiful babies are now at home with us all the time, including the youngest who was three at the time, it was a little bit more than we could work and handle. I gave way to the pandemic, and he has continued on to do great things. Then once all of that has mellowed, obviously, the pandemic isn’t over, but at least we've all figured out how to work it.

I was able to join Enterey at that point and very excited to help support all of our clients continue to do their good work and continue to achieve their corporate objectives in a wide variety of ways. It's good stuff.

Courtney: That's amazing. I know with your military career, you mentioned that you've lived all over the world. Would you be willing to share with us all the places you've lived and how that adventure was?

Harriet: Absolutely. Even before the military, I hit a classic cross-cultural American background. I think one of the interesting parts about my story is it's a classic example of you can't judge a book by its cover. My mom is from Venezuela, and my dad is from Kansas. I was born in Venezuela, but grew up in the United States. I've spent a significant amount of time visiting family down there.

When I was in the military service, I lived three years in Japan. I lived 18 months in Naples, Italy. I spent five years in San Diego, I guess a total of seven once you count some training periods there. I grew up in Atlanta. I've been in SoCal. I've lived in NorCal for the last five years now.

My dad's from Kansas. I went to school in Boston. I’ve been all over the place. It's a lot of fun. During that time in Europe, I was working on a staff that was working on a multinational exercise.

I had the chance to go down to Tunisia. I had the chance to spend some time in Malta. I had the chance to go to the southern part of Italy. There was a lot of traveling around that happened. Forgive me, I forget the question. Where did the question come in?

Mike: That was exactly it, right?

Courtney: Yeah.

Mike: Where have you been? Where in the world is Harriet Johnson?

Courtney: I have to ask also, as somebody who went to college in Northern California but has lived my entire life in Southern California, which one do you go for?

Harriet: I am NorCal all the way. No offense to our SoCal friends. But growing up on the East Coast, I love my seasons. Northern California has a full three seasons, and I can opt into snow when I want to. And that's just the best of all possible situations.

Snow is three hours away in Tahoe. It's great. I can have it for my three days a year that I want it. I can just live in the spring, in the summer, which is where you get all the accessories and the fun things. That's my jam.

Courtney: I got to say I agree. Southern California is where the family is, but Northern California always has that place in my heart as well, so I fully agree.

Harriet: And it's gorgeous down there. It's definitely beaches. The beaches and sunshine are great in Southern California. Absolutely beautiful. Love it. But choice to live, I want all three seasons.

Courtney: Absolutely.

Mike: Very good. I'm actually fond of the fourth season. I actually like snow. But I think I would probably eventually decide, I don't think I need all the snow. I can move on to just the three days a year that you're talking about.

Harriet: I'd have to blame Boston for that one, to be honest with you, because winters in Boston are bitter cold as our winters in Japan. Boston definitely prepared me for the bitter cold winters in Japan. Just after you spend a couple of times in the multiple negative digits, but I didn't grow up in them. I'm happy to hop into the snow.

Mike: Speaking of Japan, I know that you were a helicopter pilot. If I understand correctly, you were the first female helicopter pilot of a Seahawk helicopter. Is that right?

Harriet: Yeah. My squadron was HSL-51. It was one of the last squadrons to have female pilots integrated into it. I wasn't the first female pilot in the squadron, but it was what's called the composite squadron. Most of the helicopters were doing the mission of the SH-60 Bravo Sikorsky Seahawk, which I was doing. And then there was also a detachment that was specifically assigned to support the admiral that is stationed out there. He had a VIP detachment.

There were some women pilots on the VIP detachment. I was the first one on the tactical side. I was maybe female pilot number four in the squadron, but the first one on the tactical side. It was interesting and a lot of fun.

Mike: I was going to ask you, did that fact alone present any interesting challenges for you in terms of finding your way in the tactical squadron?

Harriet: I think so. I think I did a lot of growing in that space. Because going into it, I was very, very little house on the prairie, very goody two shoes. As we all know, that's not really the world that the military lives in, much less when you have anybody who's been in a major engineering field or has been a major scientific field when you walk into that male-dominated environment.

The sweet innocence that I presented at the time was maybe not the most conducive. I definitely grew a lot and learned a lot in that environment. I think it's definitely benefited me as I've come along and developed in my career.

Mike: As you've mentioned, I can tell you're very shy and not very outgoing. Was it challenging to find your leadership voice in that environment?

Harriet: I think there are a lot of incredible people. I think there is incredible service to be had no matter where your experience comes from. There are definitely challenges with being less than 10% of the population. We're 55 pilots. By the time I left, there were maybe five total women pilots. There were always only ever four or five in total.

The first female department head has gone on to do incredible things. A really amazing lady named Amy Bauernschmidt has just been named the first female helicopter pilot to be head of an aircraft carrier. Her career is sailing and doing fantastic things because she's an incredible lady who survived the Naval Academy and many others.

She has thrived in that largely male environment that I definitely had to adjust somewhat to. I think, yes, finding my leadership voice was a little bit difficult because I did present more typically feminine, more typically docile, more typically in Latin American backgrounds there is that, you listen to what the men say and you just do a thing. I had a real blind faith in leadership that there were times when it is fantastic to be a follower, and there were times when it can sometimes be hard to be a leader.

I had an aircrewman after flying with me tell me that women shouldn't be pilots. It's like, all right, it sucks to be you. That's not my problem, but that didn't happen. And then there will also be a host of great and amazing people.

I think there's a lot to be said for everyone's journey, and going and diving into the deep end, and diving into a world that you don't know. In Japan, they drive on the other side of the road. They don't have our characters, unlike places in Europe, where, hey, maybe you don't speak French, but at least you can see the letters that you grew up with on all of the signage everywhere. That's not true in Japan.

To boot at the time, we were deploying a good 50% of the time. There was just this constant flux of being in for two weeks, being out for two weeks and adjusting to the microcosm of the 25 guys that you deploy with, and then coming back home to being with the full squadron of 400 or so people.

My ability to be a leader in that environment really directly reflected other people's respective women at the time, because I don't think I super found my voice per se. When it came to official formal roles and titles, there’s a lot more that went on in the background that I had to grow into at that point in time.

Hard work will serve you anywhere you go. As long as you're working hard and doing good things, there's a lot of good to be had there. I think I found it a little bit more difficult to understand.

I should say I learned the hard way about career development from a ‘if you want to continue to grow and progress,’ you need to find the jobs that are operationally visible, because there are always tons of work to be done. There's always lots of good to be had.

In that case at that time, I filled a lot of that need to get done tasks that didn't necessarily hit the most important, most urgent category of life. That didn't serve me, but you got to learn the lesson somehow.

Mike: Yeah, I think that's a great history. But I think as I take away what you said, it's very much a learning experience.

Harriet: Absolutely, and so much good to be had. Like I said, just a lot of really great people. It's gotten me here to this day, so I have to be thankful for it. It's good stuff.

Courtney: I used to work in EMS, which is paramilitary. Definitely not military level, but I worked with a lot of people who have the same attitudes of it's a male-dominated field. There were days where I would just go home feeling so defeated and so upset. How did you keep your head up throughout those experiences?

Harriet: I am gifted or skilled with an incredible amount of resilience. I had a ship's captain once compare me to those blowup clowns that you might have when you're a kid that are weighted sand at the bottom. You just get knocked over and you just pop back up, hahaha. I have a little bit of that element of, all right, cool, what can we do today?

I was born a soccer mom and team rah-rah person long before I ever had children. I was the girlfriend that sat in the stands while my hockey-playing eventually-to-be husband was at practice in college. They brought me on to the team, I sing the national anthem, I brought him oranges, and all the dumb team mom stuff. I'm 18–22 at the time. I think that element of what's your light, what's your jam, is what you need to find and value that even if the world doesn't value that. I think that's really incredible.

We talked about leadership journeys. One of the questions that you guys gave me was, who do you admire? I think it ties into this story, because there's this one woman, Tammy Riley, who made it to the rank of captain before she retired. She's a little bit audacious, gregarious, outgoing, but she really does an amazing job of embracing who she is, getting the job done, and leading others to do good things.

I think that if I can encourage this next generation of leaders to do anything, it's to start with own your light, whatever it is. Whatever your special sauce is, just sit in it for a little while and know that your path is going to take you somewhere where that jam is good, is really good jam. Find your light, hang on to that light, and that will get you through the darkness. Also, those moments of difficulty, they're what gives you that resilience and that tenacity later on in life, but you got to see them that way.

Mike is amazing and puts us all through some internal training. One of those is everybody is rolling a rock up a hill, that that story of everybody's rolling up a rock up a hill, but one guy is building a cathedral and one guy is just shoving rocks up a hill. You got to figure out that all right, this dark moment, hey, I'm building a cathedral somewhere. I don't know what it looks like, but I'm going to see it.

Mike: Awesome.

Courtney: You said something else that really caught my ear, because I say it a lot too, which is learning things the hard way. For some reason, I always feel like I learned a lot of things the hard way when there might have been an easier way or decision that I made that I probably shouldn't.

Whenever we meet new folks here at Enterey or bring people on board, I always try to make an effort to let them know that these are all the things that I learned the hard way. I'm telling you, because I want you to learn from it and not learn it the hard way as well. Was there ever a decision that you made that you wish you wouldn't have or something along those lines?

Harriet: I make a lot of my decisions in life from the perspective of, when I'm 80, is it going to matter? What am I going to want to have done in this moment when I'm sitting with the grandkids or whoever I'm looking back on my life on my deathbed or whatever the case may be. From a career progression standpoint, I don't think so, a whole lot to be honest with you.

I've definitely been through my fair share of solidly painful moments. No doubt about it. From a professional perspective, I think they have all helped to shape and mold me into a better human being in a facet of my life that matters. The moments that I have that hit regret are random personal decisions.

I come from a singing family. When I was in Japan, I joined a choir. I had joined the Japanese choir, so I was the sole non-Japanese person in this choir. There was a moment to sing, and it turns out that I had to leave.

My tour ended on the day of the concert that we had spent months preparing for, and I wish I had given greater push back to try and stick around for one more day. I just said, all right, I'm going to follow orders. This is the day they gave me.

I did try and push a little bit, but not hard enough. That's a place where I wish I would have been more forthright. But from a career perspective, yeah, there's a lot of could have, would have, should have, but I'm here now. I think it's just a matter of it goes back to, if I could learn early on to value what I bring to the table and be truthful to that, then I think that would be great, but I can't pinpoint that to one decision.

I did a lot of just trying to follow what I was told to do and just, all right, this is the beaten path, but I've never been a cookie cutter. That's never been my thing. I'm learning now 20 years into it that there is no normal. There are a lot of beaten paths, but normal is not really a thing. That would have been really nice to know 10 years ago.

Mike: Very good. Harriet, I know in the military, a lot of people think about leadership as being very brash yelling at people and whatnot. Did you see it that way when you were in the military?

Harriet: Not at all, quite frankly. Quite the opposite. I'm very much of the philosophy that leadership is leadership is leadership, no matter where you go, especially for anybody who has been through the military in a specific leadership role. You either made it to the ranks of leadership abilities or you are an officer of any variety. The tenets and the principles of leadership are fairly universal.

What you see in the movie, the George Pattons, the war scenarios, and this, that, and the other, those exist, for sure. But that's the glorious 10%, not the daily 90%. The daily 90% is so much more the same thing that works here in the real world. How much have you build respect for other people so that they'll give it back to you? How much did you support the individual so that when they came to work, they were able to be a whole human being?

How much did you try and get the roadblocks out of the way so that the people who needed to do the work weren't sitting there moving roadblocks, they were just traveling down the road that you've asked them to travel on? I think that that is largely undercredited.

I worry sometimes when I say, hey, I'm a veteran of people going, oh, so you're probably a barker. It's like, no We have a lot of great phrases in the military. It depends on your service, branch of services to what they are. But one of the ones in the Navy is if you take care of the people, the mission will take care of itself.

I really think that's true. I really think there's a lot to be said for that. It's a lot of what attracted me to Enterey, the whole people, drive results, tagline. It just really sings true to me. Yeah, I think leadership is leadership, no matter where you are.

Mike: Hey, Courtney. A lot of our clients we work with have great ideas on how to improve their business, but they just run into challenges that seem to get in the way of accomplishing their goals. Have you ever seen that?

Courtney: Of course. It happens all the time. I've seen clients struggle with a lack of visibility into all the work that's happening within their organization. I've seen clients that are focused on manual tasks, which takes away from focusing on the actual project work. And I've seen leadership struggle to make decisions due to lack of timely information.

Mike: That's so true. It seems like just knowing the problems to fix is only half the battle. How do you help your clients address those challenges?

Courtney: We of course, first work with our client to design a structured management process that fits their culture and team. In a lot of situations, we bring in tools like Smartsheet to help the entire project team be more efficient. With the help of Smartsheet, we were able to create dashboards, automate routine tasks, and have the information ready in real time to help support leadership's decision making.

Mike: Wow, it sounds like you not only execute on the project, but your work helps everyone get more done with less work.

Courtney: I hope so. Smartsheet is a powerful tool, and my clients seem to be really happy with it.

Mike: That's great. Now, if somebody needs help on their project, what should they do?

Courtney: They should check out enterey.com and schedule a call with us to see how we can help.

Mike: Sounds like a great idea.

Courtney: Thank you.

Mike: I think it's great. You now have moved beyond the Navy. You have four kids at home. Do you see leadership that you've developed while you're in the Navy applying to your personal life, with your kids, and even at work here and with your clients?

Harriet: Absolutely. I think people can learn leadership from many, many grounds. There is no single leadership training source by any stretch. I am continually intrigued by how the 11 leadership principles just directly apply to my family life as well. You can look them up on the Internet, but know yourself and seek self-improvement.

I don't know a parent who isn't trying to do it better day by day. I don't know a leader in the real world who is a leader for real, not necessarily a manager, but a leader who isn't doubting themselves and wondering how they can improve themselves.

For my children, specifically, there's train your people as a team, ensure the task is understood, supervised, and accomplished. I don't know a parent that doesn't struggle with having their child do an activity, finding it to be 70%, complete, and then and now you're at a leadership crossroads.

What am I going to do about this? Am I going to do the job myself? Am I going to coach my kid to get emotionally done? Am I going to yell at my child for not completing what they've got going on? Am I going to some combination of all of these things?

I think the thing that really maps the most for me between military leadership, those tenets that I learned as a naval officer, and the trials that I've been through leading these four precious people to where they are in life, ages 4–12, has come to understand that for my children, especially, they have their perspective and their street corner.

Sometimes their horizon and how far out they can see is very different from my own. That's really obvious with children. Your two-year-old, their life is all of five minutes out. If it had been five minutes in the past or five minutes in the future, that's where they are.

That black and white perspective on, everybody has their own perspective, rings really true and maps over really nicely for me to the business world, except not everybody's a two-year-old. Nobody's a two-year-old quite frankly. They're their own adults with their own perspectives and their own whereabouts, but it's really helpful for me to realize they might be standing on the opposite side of the street.

We're on the same street, we're trying to go the same direction, and I'm like, hey, we got to go right. And they're like, no, left. No, we got to go right. No, left. It's just that understanding of taking a step back out of yourself to say, where are they right now? Okay, how do I help? How do I get to them or bring them to me so that we're all speaking the same language?

Having my children is just an extreme example of they're hungry. If I don't feed them first, they won't listen. That's just all there is to it. I think it applies in real conversation as well. If you don't listen to another person first, you're never going to be heard. We just think as adults, we're adults. Let's all be adults here. And it's like, no, we're all people, 2, 82, 42. We're all people.

Mike: That's great. I love what you just said that in order for people to hear you, you have to listen to them first. I think it's a great statement.

Harriet: It's been one of the hardest lessons to learn. Admittedly, I have to relearn it all the time. I think I'm fairly well-versed academically from a leadership perspective, but I'm always really impressed by how leadership is such a journey. It's not, I can learn this lesson today and forget it tomorrow. Again, and just go, all right, it's time to get back up on that horse. All right, I didn't listen today, so I was less effective. How can we listen better tomorrow?

Courtney: I think it's an excellent statement, too. I grew up in Southern California, and going to UC Santa Cruz in Northern California, it was a completely opposite experience. It's in the same state, but it was not the same state.

Harriet: They're very different.

Courtney: Very different. It was a little bit of a culture shock. There were a lot of times I found myself interacting with people or in a class where I didn't necessarily agree with what was being said. But because I don't agree doesn't mean I can't listen and understand their intentions, and why they think the way they do, and what their experiences have been to lead them to that conclusion.

I think my greatest takeaway from my education is that you do not have to agree with somebody, but you do have to make an effort to understand where they're coming from, why they think the way they do, and how you can try to compromise and try to work with their vision and what they experience.

Harriet: Courtney, I'd have to admire you and say you're well ahead of the curve. I guess one of the things that I'm learning now as an adult is that because my truth and your truth don't agree with one another does not make either of them less true. There just really is that opportunity for there to be multiple correct or multiple valid expressions of an opinion, a conversation, or a viewpoint. It's not all or nothing. As human beings, we really describe things really black or white, especially here in the United States.

We do a lot of things that are very black or white. You can see that reflected in the politics of today. We're not going to go there, but you can see that very truthfully. Taking that alternate perspective that you just mentioned now about how, hey, I understand where you have come from, I see where you are, I am not there, and this is okay. This does not make you any less. It does not make me any less. We both just are in our different locations.

Courtney: Exactly.

Mike: I agree. That's actually an interesting perspective that I think about in terms of the difference between maybe a military experience versus a corporate experience. I'm curious about how maybe you experienced that when you went from the Navy and then into a very corporate environment at Merck. Did you see that difference firsthand when you made the change, or was it very similar?

Harriet: They're very different worlds. I think there are some places where the military does a really nice job of saying, what is black is black, what is white is white, what is red is red. There are some very distinctive lines. I think what the military does very well for the most part is, how is it less important than your results? Did you get the job done? There is some beauty and some pain in that, because you will put in your pound of flesh to give to what needs to happen. I think that's very well recognized, very honorable, and very service-oriented.

In the business world, there are a lot more people that care about how you do it. There's a lot more opportunity to do so many things. There really are. The world is your oyster. What do you want to make it? How do you want to do it? Almost every single state is not will state.

In the military, like, no, you were obligated contractually to service until your service date is up. If you were me, I would have taken an aviation contract. At the point at which I was four years when I graduated, guaranteed, going to do four years, pay back for my college scholarship, no problem.

But a year-and-a-half later, as soon as I got pinned to Naval aviator, it was 10 years from the day of winging. I wasn't going anywhere for a very long time. There are different worlds that teach different good, bad, and both of the situations. They're just different worlds.

Mike: That's great. I do have one Navy question for you and that is, if you're willing to share, what was your callsign?

Harriet: My callsign was hairball, because it is a play on Harriet. It didn't necessarily get used a whole lot. There were definitely a couple others that were less choice that got into the mix beforehand. I think the callsign was a little bit of a play on the situation. I'm pretty goody two-shoes, pretty green.

Again, young woman in a largely male environment. You have three tiers of people in their careers in a squadron. You have the commanding officer and the executive officer who are your senior ranking individuals. You have 10 or 12 department heads, and then you have the majority 30–40 or so pilots who are ages 25–27. Most of them, give or take. There are some exceptions to that. You're in year one, year two, or year three of that tour as a pilot.

I was the one woman in that bottom tier of folks or one of three or four women in that bottom tier of folks. Hairball was a little bit of a play on kid's sister, why are you here, a play on the name, and kosher, because like I said, there was a couple that didn't quite survive because they were not politically correct. So it goes.

Mike: Cool. It made sense to me as soon as you mentioned it. I'm the Harriet and hairball. Hey, it's good.

Courtney: You mentioned, Harriet, earlier that you like crafting. What kinds of crafts do you like doing? I want to know because I'm super crafty, too.

Harriet: Nice. I love crafting. I have been doing things with my hands since I was 10 or younger, whatever the case may be. It depends on the year. Right now, I've been making masks during the pandemic. Prior to this, I've made hair bows, little girls' hair bows. I've got four daughters, so that was a very popular craft with my children. Where I had daughters and I could do their hair, now they don't let me touch their heads, which is fine.

It's come full circle, though. My 12-year-old now likes the hairbows. She puts them in her own hair. It's been fun. I've gotten the chance to make a couple for her. I've also done paper crafts, so making cards. I never really got into the scrapbooking thing.

That's just maybe a little bit too much of a project. I seem to like any small craft that can hit the one- to two-hour roam. It's my sweet spot. I can do things that take up to 5–7 hours. I've done a little bit of crochet, knitting, and things. When I was really young, like high school, I actually made paper dolls. They look like that corn husk material, but it was scrunched up paper and a wide variety. I would make these 8–12-inch dolls that would decorate your house, because it was the 90s. That stuff was kitsch. It was good at the time.

Mike: I don't know if any of your girls are in dance, but if you find some friends that are in dance, they need a lot of hair bows.

Harriet: You're right. That could be a good niche market for me. I love it.

Mike: Great.

Courtney: My mom was the best cheerleading role maker when I was in high school. Then in college, she still wanted to continue her cheer mom role, so she made the whole team a bunch of bows. It was really fun. Yeah, there's always a spot for more bows.

Harriet: Indeed.

Mike: Harriet, I want you to be honest. Do you wish you could still fly a helicopter in everyday life, like going to a grocery store or taking the kids to school, letting them rappel out to drop into the playground or something?

Harriet: It would be awesome. Being a helicopter pilot is just really, really fantastic and a lot of fun. My personality wasn't built for the political side of where things were, but the actual flying element of it is a joy and a thrill. It definitely pushes some really fine buttons for me, personally. I think it's funny when I'm taking a couple surveys with, how are you compared to your spouse and certain things?

I would argue that my husband is the safer driver, but I am the more tactically proficient driver. The other day, I pulled out of my drive, and my children were like, oh, I forgot this basic item of whatever variety. I was like, all right, cool. I flipped my hand over the backseat, turned it in reverse, and pulled it 25 miles an hour back into my driveway in reverse, perfectly centered on the drive. My children were like, whoa, mom. I was like, ooh, I probably shouldn't have done that in front of you, but I'm capable.

Mike: Very good. We should have got that one on video.

Harriet: Don't do that at home, kids.

Mike: Very cool. I'm curious, looking back and talking to some of our listeners who are maybe looking for some nuggets, what are some of the ideas? What are some of the ideas that for someone who's growing in their career, how would you say to them, do this or don't do this in order to build their leadership capabilities and their path?

Harriet: I think wherever you have an interest, you need to continue trying to learn. Whatever it is that feeds you in that variety, keep doing that. I would say lead where you stand. Don't wait to be handed a leadership opportunity. You're standing in the middle of one somehow.

Whether that is an opportunity to, I said I sing, so I sing in the choir at church. Recently, the person who normally leads the choir hasn't come back. Hey, there's a void there. If I'm willing to do the planning, the sending out of the notes to everybody, and the things that come with that leadership role, then it's there and available to me. I think that's true for everyone, no matter where you stand in life.

As a young operator, or as a junior person just coming in, Courtney is sitting here doing this podcast with you. This is an opportunity for her to learn from your expertise and lean into where you go. I don't know a company that doesn't have internal initiatives that needs somebody to drive them.

That's a prime opportunity for our junior folks to really show themselves, show what they've got, potentially learn in a safe space where you can make those hiccups and mistakes, because there'll be somebody there to turn to.

I would also just put out there that you're not alone. You might be solely responsible, but you're not alone. So leverage your networks, the people that sit next to you, somebody that you admire, or somebody that is one rank up from you, whatever that happens to be. One or two ranks up from you as a prime space.

Especially if you're struggling with your direct manager, direct boss, and they happen to be two or three ranks above you, somebody has an in-between to just be like, hey, I want to serve my boss well. We're not communicating right now. This is what I'm trying to say. Can you help me flesh out what I'm trying to say before I go talk to my boss?

Everybody loves to do that for other people. I don't know anybody who doesn't want to help mentor, coach, or otherwise. You just got to ask. Don't worry about looking silly. Don't worry about falling flat on your face. That's the opportunity that you have.

My kids when they were in the first grade were like, mom, failures, your first first attempt in learning. I was like, oh, that's a smart kid. That's fantastic, because it really is successes that last time that you picked yourself up from when you fell down. I'd say lead from where you stand.

There is an opportunity in front of you. Just keep learning. Just keep having these conversations—going to TED talks, going to whatever your favorite podcast is. There's a boatload of leadership podcasts and leadership opportunities. Whatever the avenue is that works for your life—books, podcasts, talking to people, a cup of coffee with an old folks home, candy stripping in a hospital, or going to those locations where our eldest communities are going. The greatest generation right now is we're losing them.

We think the pandemic is hard. They lived through World War I, in Korea, in World War II. I think about my grandfather who went from lights to not quite the Internet, but pretty close. Horse drawn carriage to F1 racing. The generations that came before us have lived a hot minute. It's not documented on social media, thank goodness, but they've been there somewhere. Your chances to grow are all around you depending on what works for your life.

Mike: I love it. I want to add one thing, because I totally agree with what you said, particularly about the learning aspect. I will tell you as well or I will suggest that I have learned so much from Courtney about how to do a podcast. Courtney hopefully can garner some insights from me, but I'm totally learning a lot from her as well. There's a 360 degree view of where we can learn, so I wholeheartedly agree with what you're saying.

Harriet: That's awesome.

Courtney: Thank you, Mike, first off. I really enjoy hosting this podcast with you. It's exciting that there's this opportunity in the first place. Harriet, you said something that really piqued my interest about recruiting help, asking others and bringing others, and when you do need the help and in terms of leadership. It reminds me, have you guys seen Dr. Death or heard of Dr. Death? It's a show that's on I think it's Peacock, NBC, and then there's a podcast, I'm wondering as well.

Essentially, it was about this physician who was a psychopath, sociopath. He had this mindset of, oh, if I mess up, it's okay, I'll try again. I'll just have this ‘fake it till I make it,’ ‘in it to win it’ mindset of I'll keep trying and I'll get better, but it was at the expense of patients' minds.

It's an example of the opposite. But part of what they cite in that case is the Hippocratic Oath, where if you can't do it, then you will recruit a colleague who can. They hammered that [...], if you can't do it, recruit a colleague, get in a conflict, get that second opinion. Get other people in to help.

I find myself doing that quite frequently working with clients. For instance, I spoke with you yesterday. I was like, hey, what do you think here? It's so nice to be in this environment and to have people that you can recruit in to help. Leadership is all around, I guess.

Mike: It's awesome. Harriet, you and I talked one day. We had lots of interesting parallels in our history and whatnot. What I found out today is that you sing at church. I don't sing at church, but my wife does. She used to sing in the choir. She used to cantor at mass. It's an interesting connection there, too.

I guess it would have been more of a parallel if your husband actually sang, because then our respective spouses would be the singers. But nonetheless, we have a singing vibe going on, so it's very cool.

Let's see. I think we got to start wrapping it up here. What do you think, Courtney?

Courtney: Yeah, I think it's game time.

Mike: Game time. All right.

Harriet: Thank you both for the opportunity to be here. I just think, Mike, I'm really impressed by how you continue to serve the internal community and try to bring what we have internally to Enterey. To support others, I think that's really amazing and fantastic, and that you're letting the youngest among us join us, and do that collaborative environment of learning from all avenues. I think that's just so impressive. Thank you both for inviting me on board and having the chance to speak to you today. It's been great.

Mike: Awesome. We really appreciate you coming, spending your time with us, and sharing your background. I think it's really great to get to know everybody, you in this case in much more detail, and the history behind how you got here today. I'm excited.

Courtney: Of course. As somebody who works with you, Harriet, and looks up to you, I can testify to all of our listeners right now that everything Harriet said here today is not just all talk. It's very true. She very much lives out everything she said. She really does set an example, tries to remove obstacles for people, and really does lead the way for all of us consultants here at Enterey. Thank you, Harriet.

Harriet: I'm honored by those words. Thank you.

Mike: Very good. All right. Now we're moving into game time. I think Harriet, you're the star of the show here again.

Harriet: That's right. There's a game. I forgot about that. Let's do it.

Mike: Right up your alley.

Courtney: The game, it's really simple. It's like this or that. We would play that game in our meetings, but it's lightning round. I'm going to give you a minute, Harriet, to ask all of these questions. Hopefully, we could just do our best to answer them.

Harriet: Awesome.

Courtney: All right. I'm going to set my phone as a timer so I can make it fair, because the stakes are high here. Scale of 1 to 10, how good are you at keeping secrets?

Harriet: Eight-and-a-half.

Courtney: Arielle or Jasmine.

Harriet: Arielle all the way.

Courtney: First celebrity crush?

Harriet: Tom Cruise. Not anymore, though.

Courtney: Dawn or dusk?

Harriet: Dawn.

Courtney: If you could travel back in time, what period would you go to?

Harriet: The Renaissance was the first thing that came to mind.

Courtney: Do you snore?

Harriet: Occasionally, but not normally.

Courtney: Place you most want to travel to?

Harriet: Fiji.

Courtney: Favorite junk food?

Harriet: Ice cream.

Courtney: Favorite childhood TV show?

Harriet: There are so many good ones. The Gummy Bears.

Courtney: Favorite season?

Harriet: Spring or fall. I'm really torn.

Courtney: Okay, last Halloween costume?

Harriet: I was a witch, but that's just because I default to that as a parent.

Courtney: Time's up.

Harriet: What's the last question? I'm curious.

Courtney: I was going to ask, cake or pie?

Harriet: Oh, cake all the way.

Courtney: Good to know. That was fun. Eight-and-a-half, scale of 1–10 on keeping secrets.

Harriet: It depends on the situation. But yeah, for the most part that I need to keep a secret, I will.

Courtney: I'm a four. I have to admit. I can't lie and I can't keep it.

Mike: That's classic. Very good answers. Those are some good ones.

Harriet: I can sing end to end The Little Mermaid for you, the whole nine yards. Whereas I can only think probably half of Aladdin to you. But I think that has to do with, I was the right age. I was 12 years old or something close to that when The Little Mermaid came out. I was just all about it.

Courtney: That's so awesome.

Mike: Very cool. That's great.

Courtney: All right, Mike. Are you ready?

Mike: Yeah, are you going to do this for me too?

Courtney: Yeah, but they're different questions this time.

Mike: Oh, oh, different questions.

Harriet: Let's do it.

Mike: All right, I'm ready. Let's go.

Courtney: Okay, pressing start. Favorite ice cream flavor?

Mike: Oh, double chocolate malted crunch.

Courtney: Can you say a word in Spanish?

Mike: Bienvenidos.

Courtney: Do you believe in fate?

Mike: Absolutely.

Courtney: What's your favorite number?

Mike: Eight.

Courtney: Who has it easier, men or women?

Mike: Oh, my God. You can't make me answer that question.

Courtney: We can skip that one.

Mike: Men. Definitely, men.

Courtney: Okay. Have you ever worn socks with sandals?

Mike: Oh, God. Yes, probably.

Courtney: Okay, name a primate besides monkeys and apes.

Mike: Goodness. Orangutan. Is that in the monkey and ape category?

Courtney: Yeah, I'll take it. Sourdough or wheat?

Mike: Sourdough.

Courtney: Name one of the seven dwarves.

Mike: Grumpy.

Courtney: What's for dinner tonight?

Mike: I know that I'm cooking dinner tonight. I have not yet decided, but something with chicken in it.

Harriet: Cool. There's a chicken thawing in my fridge here to be part of dinner. It's fabulous.

Courtney: Do you cook for your family a lot, Mike?

Mike: I don't. We had a conversation. My wife and I had a conversation this weekend. She went with my son to visit her mom a few weeks ago. It was just me and my daughter, so I was of course in charge of everything while she was gone, my wife was gone.

One night, we made fried chicken and waffles. The next night, I made custom fancy hamburgers. My wife's like, I heard when I was gone, you made chicken and waffles. I said that tonight, I would make dinner.

Courtney: That's nice.

Mike: Usually, when I make dinner, it's not really on the healthy side. It's usually part of the issue.

Courtney: That's okay. It's called balance.

Mike: That's right. Very much so. Well, cool. That was fun. I like that. I want to do that some more.

Harriet: It's super fun. Thank you guys for bringing me on this journey. It's been cool.

Courtney: Of course, we're happy to have you.

Mike: All right. Awesome. We're going to go ahead and wrap it up now. Thank you very much again to our wonderful guest, Harriet Johnson. We look forward to talking to you all in our next episode.