Women Leading Validation Spotlight: Katie Terry - Culture of Learning

On today’s episode of Women Leading Validation, Dori Gonzalez-Acevedo, CEO of ProcellaRX interviews Katie Terry. 

A fellow Chief member, Katie is a life science executive bringing over 20 years of experience in drug development, quality, and manufacturing.  She holds a bachelor of science in biology from Utica University and a MBA from Simmons School of Management.  Katie has held leadership roles at Biogen, Alnylam, and most recently Acceleron, where she was the Vice President of Quality.  She has a passion for building global high performing teams, transforming early stage firms nearing commercialization, and promoting a compliance-centric culture.  Katie recently transitioned to consulting where she advises life science executives on topics such as quality management systems, manufacturing strategies, and commercial launch readiness. 

*Disclaimer: Podcast guest participated in the podcast as an individual subject matter expert and contributor. The views and opinions they share are not necessarily shared by their employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.

This is a joint Podcast production of ProcellaRX and KENX

Transcript

Dori Gonzalez-Acevedo: 0:02

Welcome to another episode of women leaning validation. I'm your host Dori Gonzalez-Acevedo. On today's episode of women living validation I interviewed Katie Terry, a fellow chief member Katie is Life Science executive bringing 20 years experience in drug development, quality and manufacturing. She holds a Bachelor of Science in Biology from Utica University and an MBA from Siemens School of Management. Katie has held leadership roles at Biogen and align them, and most recently acceleron, where she was the vice president of quality. She has a passion for building global high performing teams, transforming early stage firms nearing commercialization and promoting a compliance centric culture. Katie recently transitioned to consulting where she advises Life Science executives on topics such as quality management systems, manufacturing strategies, and commercial launch readiness. Let's listen to Katie's perspective on how to say yes, and, and how transformations are hard work and can happen if you lead by example. Without further delay, Katie Terry. All right. Well, welcome Katie. How are you today?

Katie Terry: 1:09

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

Dori Gonzalez-Acevedo: 1:13

Well, I you know, it's been a scheduling issue for for a lot of us right, trying to get this on the calendar. I know we had it on the calendar, and then we had to reschedule and and I'm so glad that you were able to join me this morning for a nice conversation on women leading validation. The, when we get started, I think that would be really helpful to give folks I know, I went through your bio, but it would be helpful for you to give a little bit more context about who you are, and why this topic is passionate to you.

Katie Terry: 1:45

Yeah, thank you, I appreciate the introduction and the kind words, it has been anything but linear is kind of how I describe my career, I started very humbly with manufacturing experience working in a QC lab. And from there, I've just worked my way through manufacturing roles, validation roles, into overseeing CMOS, and I've landed in quality, and it really became a passion of mine. Because I see it as so much more than processes and systems. It's really about connecting people. And it's about the integrity of the work and the ethics, the piece of ethics that comes with that, that really excites me. So I I have enjoyed my time and quality. And I really see it as a competitive advantage, especially for some of these small companies.

Dori Gonzalez-Acevedo: 2:36

So by education, your chemist, right?

Unknown: 2:39

Oh, I'm a biologist by education. That's right. And then I earned an MBA from there.

Dori Gonzalez-Acevedo: 2:46

So how and how does that kind of play into the quality roles? Because I know sort of all of us have those kind of transition points. So how did you get to from biologists to where you are today? Like what changed for you?

Unknown: 2:59

Yeah, I really realized when I was in the QC department, as much as I enjoyed learning, some of those routine practices, the procedures, everything that's fundamental to what we do. In manufacturing, there was a piece that I was missing. And it was that business piece, like I was saying earlier, it's about the interconnectivity of different departments, different functions, different people. And that's what really drove me to get my MBA, I wanted to see things in a bigger picture. And I really wanted to understand what the work the work that I was doing, what did it mean, and how did it fit into the larger organization. So after I earned my MBA, I really used a lot of those business skills, whether it be project management, or negotiations, about ability to influence I loved organizational design and those organizational behavior courses. And that brought me into more of a leadership role. And my first leadership role was actually a manager of validation. And I had a small team. And I just loved everything about working with that team and mentoring and helping and coaching and seeing other people grow. So I took that passion. And I brought that over into other roles. And like I said, it was anything but linear. I was really willing to accept roles outside my comfort zone, I was willing to step into roles that I probably had so much more to learn that I even knew, knowing it to them. So it made my career very fun and very exciting.

Dori Gonzalez-Acevedo: 4:34

So part of what I hear you saying also is this culture and mindset of a yes and sort of mentality. So while you started out here, there was a lot of yeses that you said along the way in order to kind of be where you're at today, which is strategically helping folks in this space to write.

Unknown: 4:53

Mm hmm. That's right. And I think that's always what I tell folks is, don't be afraid to say yes and try some thing new, I think we grow when we're outside of our comfort zone. And I think that's where the transformation really happened for me personally, going either from an individual contributor to a manager, or from that director level, and to that executive level, and those transformations are hard, but they're critical.

Dori Gonzalez-Acevedo: 5:20

So I often say, getting folks to be comfortable in the uncomfortable is like the heart of change, right. And if we're not able to sit there, in that uncomfortable space, we're not really evolving as an individual or as an organization, right, or as a department or a team or whatever, right? Because that friction is needed in order to elicit the next whatever, right? So in your evolution, from a career perspective, I know you have had, you know, you've you spanned the the a lot, right, from preclinical to commercial side? How is that kind of changed? Or how, what's your evolution been in that space?

Unknown: 6:04

Oh, that's a great question. It's actually been an evolution really around risk, and understanding risk. And also, to be totally candid, embracing things that aren't perfect. It's really hard being type A in this industry, and then working through the evolution of a company and growing with that company. Because when you start, you start with the basics, you start with the fundamentals, what you really need to get that product out the door, get that product in the clinic, and it may not be perfect. And so you have to be really comfortable in that space. And I think what I've really grown to appreciate is this growth mindset, and the value in continuous improvement and trying to instill that in those around me.

Dori Gonzalez-Acevedo: 6:50

So that's a hard conversation to have. So can you share maybe an example of, you know, how you've kind of navigated that and getting folks to the table to shift that mindset?

Unknown: 7:02

Yeah, that's, that's another good question. So what I tried to do, and this is what I used to tell my staff, take the time with every interaction, every interaction matters when you're trying to shift the quality culture. So it's, it's more about listening. And it's more about trying to understand where that person is coming from, and why they have such a need for perfect versus done. And we start to talk about risk. I have an example where we did this procedure, we had, you know, change control procedure, and everybody wanted, it's so big, and so many layers, and so, governance and all these processes around it, and I tried to ask him what what what's so important today, you know, we're in phase two, we're moving into phase three, what is the worst that's going to happen, if we didn't put in the governance, if we didn't put in these seven or eight extra steps. And we really started to kind of process map and tease these things out, and try to scale back and get people to see the value and scaling back. And then going forward and evolving and taking those ideas. But they're not easy. It requires a lot of patience, very good listening skills, and the ability to really empathize, put yourself in somebody else's shoes, like I built this, like, I want to work on this, and how do you get them to kind of think differently? Yeah,

Dori Gonzalez-Acevedo: 8:25

yeah, that's interesting. So it's a, you know, I see a lot of times where the over engineering of a quality process has happened, right. And with each change of maybe quality leadership, there's then the next layer of of that additional process in place, because it wasn't again, you know, to someone else's liking, right. What I, as a strategic consultant myself, right, what I, what I try to help folks do is to disrupt the whole thing in order to remake it right. And so kind of rethink the whole process. And part of doing that is you got to bust it all up. What I like about what you're saying is asking those questions in a in service of trying to figure out what the other people at the table are thinking about. Right. And so how do you get the right people at the table? Because I think that that's also something perhaps you've seen, you know, maybe not all the right decision makers are at the table. Am I too far off enough?

Unknown: 9:33

No, I think that that's a really valid point. I think one of the things and maybe it's just part of, you know, an onboarding process, I'm not sure where it would really fit but with any new role or any new project, it's really about dissecting, who are those decision makers because it's not by title. It's not by positional power. Sometimes it's by the voice and the power of that voice that that individual carries and the ability that they have to influence. So I think it's about being really savvy about knowing your players, and knowing the dynamics within, you know, whatever that may be your new role, your new project team, and investing that time upfront to actually understand that, I mean, not always can't happen. So usually, it unfolds right in front of you. And you may have to pivot in the middle of a project or in the middle of some sort of initiative to get those players there. But that is always difficult to navigate. But those are kind of the strategies that I tried to use.

Dori Gonzalez-Acevedo: 10:32

So you use the interesting word that I've been using, and I think a catch term now just given COVID, right, this pivoting mindset, right. And when we talk about validation, right, pivoting is not something that as an industry, the validation teams in general, do well. What are some of your thoughts there?

Unknown: 10:59

Yeah, I'm laughing because I used to always joke and say, you know, the validation team, it's like, we're last on the schedule, we always get the time crunch, we're always under pressure are always trying to kind of make up time and figure out how are we going to do things faster, better, quicker, and have really good data or data that represents whatever it is that we're working on? Gosh, actually forgot what the question

Dori Gonzalez-Acevedo: 11:24

is around pivoting validation teams can't, can't, can't pivot very well.

Unknown: 11:30

No, because as because, because of all the time crunch. So I think that on the validation side, it's really about that project management. So coming back to the project manager and understanding the sequence of events, what's holding up, what is this link to the filing? So understanding the downstream consequences and trying to pivot from there? But yeah, it's never easy when you're the last kind of the last one on that project schedule.

Dori Gonzalez-Acevedo: 11:54

Yeah. And I think, you know, again, historically, validation has been a very waterfall sort of way of being right. And I think one of the gifts of, of COVID is been that that risk element has been highlighted, right? And you we need to figure out how to do a more integrated or single goal agile, if you will, right process to get to the heart of what it is, right? Versus there's that perfect what you talked about before, right? This perfect mindset where everything has to go according to this B model and this specific thing, and every requirement needs to be as explicit as the next, you know, and that's really shown that that's not reality. Right? But how to break the mold, right, from that way of being to this new paradigm requires a lot more effort than than folks do. And what I'm curious about what you think about, like the leadership level, and what they think about that, right, because that takes effort, right, that takes more resources time, you know, education in order to change some of those things. are what are you seeing in that sort of area?

Unknown: 13:18

Yeah, what I've observed is that it is an element of education. And what I found, at least on our most recent experience, is what's really important is issue escalation and how we talk about those risks to leadership, because sometimes, it's hard to really wrap your head around, what are the implications to my five year business strategy? Or what are the implications to the pre approval inspection that we have hanging over our head. And so it's really about learning how to talk about quality, or validation, or whatever that hot topic is, in a way that links it back to a strategy that links it back to sort of a corporate objective. And that becomes so tangible for leaders that they can really understand, you know, they don't want to they don't want to know what's in the SOP. They don't care how many SOPs we have. So when you go and you start to reestablish, or if you have a really well, robust governance in place, when you go to those types of meetings. You're not just presenting like, oh, you know, we had three deviations, or it's talking about what these mean to the overall business, and can we still move forward? Can we still hit our projections? And are we going to be successful with that new asset that we're trying to bring forward? Because that's usually what the smaller companies are trying to do. And then the only other thought I have is I have observed a new appreciation for quality. I found that a lot of companies are either trying to figure out what is the right time to bring on a quality leader and sort of build out this function so that way we can get things right and get through these pre approved All inspections with a little less pain and hurt and bruises. So there's a lot of thought going into it. But you know, we still need refinement, I think the industry is growing in this perspective.

Dori Gonzalez-Acevedo: 15:11

Yeah. I'm curious, do you have a definition of quality? Because I think that that's something that the industry also struggles with.

Unknown: 15:21

Yeah, it's so funny, as I was preparing for this, I was thinking about that. And I was like, oh, gosh, everybody says, you know, fit for use are free of defects. That, to me, it's, it's not about just the processes or the systems. To me, I think about and I was just talking to someone about this, we need to shift the mindset from quality to compliance, because compliance is so broad. And it's really about the integrity and the ethics that we bring to our work. And that really resonates with people on a very different level opposed to well, we have the right QMS. And we have the right infrastructure, those are the tactical tools that enable people to do their jobs and do their jobs efficiently. To me, quality is about, especially in smaller companies, it's about the behavior. It's how we talk about risk, it's how we show up every day, and we we hit these challenges, and we work through them together, and we come out stronger on the other side, I think there's so much more to it than, you know, the the old adage of fit for purpose, and that's to make sure our products are safe and effective. That's the minimum.

Dori Gonzalez-Acevedo: 16:30

Right? Yeah, yeah. I like what you're saying. Yeah. I know, you know, in some of the larger organizations and, you know, siloed groups, right? So have you can you speak a little bit to about how to take that concept, right of what we were just talking about, and, and really spread that across an organization? Because I do see still a lot, right, have this group does it this or thinks of it this way, and this group things in this way, and for equality leaders, how to kind of hold that space for that standard that you were just talking about to be really the bare minimum across the board?

Unknown: 17:10

Yeah, I mean, for me, I've always worked in these smaller to mid sized companies. So being able to reach across the aisle, if you will, has come naturally to me, maybe it's my personality, who knows. But I do consider myself a connector. And what I mean by that is, I think it's important for an enterprise leader in a quality role, to feel comfortable to reach out to other people in medical affairs, or it throughout the r&d organization. Even in commercial, I work very closely with someone on the commercial training side, just so I could understand their business. What are they doing? How do they operate? And if How can quality serve? Right? How can the quality units serve what you're trying to do? So you have a quality product, you reach the patients in an effective, streamlined manner, that also meets the regulations that govern your side of the house. So I think it's this element of interconnectivity, curiosity, and just really understanding other people's business and how it all comes together.

Dori Gonzalez-Acevedo: 18:14

Yeah. One of the one, what I hear what you're saying, also is the servant leadership sort of mindset, right, which I think in service of what in service, so you know, and in an upcoming release podcast, I talked to another chief member as well. And talking about, you know, the connectedness throughout all the way down to the patient, right. And when you have that connectedness, right, whether it's within your organization, that you feel that connectedness or and all the way through from your product, or whatever, the multiple products to the patient, your mindset changes, right? You can't come to the table and not forget that, you know that right? Or forget that you're sitting at a table with IT guys and security guys, and this and that, or whoever, like, and they're also coming to it with all of their demands and needs. Right, that that are there. And so if we have more context for, for the conversation, before we go into the conversation, it's much more helpful to figure out what that end goal is collectively, right. Awesome. Yeah, so, you know, given that you I also like the small and midsize companies too, because you get to do a lot more within the in those frameworks. So what are some of the interesting things that you've been able to do that you didn't think you were gonna be able to do?

Unknown: 19:50

Well, for starters, I would have never thought I would understand GCP good clinical practices the way that I do I feel very grateful. to a past experience that I had that it was one of those things I said, Yes. And I showed up. And I worked with a really amazing team. And I learned the language, I understand the business a little bit better about what it means to actually conduct the clinical trial. And I think, you know, comes back to that willingness and that openness around, I don't know this, I'm okay, not knowing this. But showing up authentically and saying that and just talking to people about it, like, Hey, I'm in this role, I have this new job, I'm going to need your help. And this is what that help is going to look like. And so finding those people that are supporters and subject matter experts and sort of insulating yourself, I would have never thought I would have had that experience. It was really tremendous, to be honest with you. It's one of those ones that I would consider transformation optional.

Dori Gonzalez-Acevedo: 20:50

Awesome. Yeah. That's wonderful that you were able to get that I think that one of the things you said, in your response around authentic leadership, and something that I'm also passionate about. I wonder if you were wanting to comment a little bit about, you know, what that is, from your female perspective, versus what that might look like outside of that, because I think, for me, at least, my understanding and definition of that is, is very colored by who I am as a woman.

Unknown: 21:23

Yeah, I agree. It is very colored, and it shapes how I show up. I am so much more than just an employee. I'm a mother, I'm a friend, I'm a sister, I'm a daughter. And we have all these challenges. And these live our lives that we have to balance. And sometimes we say no to things that we wish we could say yes to. And sometimes we just we have to say no to those things, because work demands it. So it's really kind of balancing that but not being afraid to talk about it. It took me a really long time to get there. To be honest with you, I was always very guarded, especially my younger self, I was very guarded. And how I showed up is very professional, you know, always wearing the pantsuit and always trying to kind of keep it together and keep that piece of me. Not necessarily silenced, but not so prominent. And as I grew and I became a parent, I just had to live a little lighter. To be honest with you. I wanted to live lighter. I wanted to be myself. I still love my pantsuits. I still but I, I really wanted my sense of humor to be able to show up at work, I wanted to use that as levity and keep the team grounded. But most importantly, I found that I, you know, I want to have fun with the people that I'm around, and how can I be myself, I and still have fun and be the parent that I want it to be it all really took me a long time to get there.

Dori Gonzalez-Acevedo: 22:49

Yeah, a lot of what you're saying rings true for me too. And it's part of, you know, women needing validation, our hope and goal is to be able to, you know, share experiences, such that the next generation and then folks in the mid career to kind of see that this is not something that just magically, you know, we've all possessed in being able to show up doing right. It's been a lot of struggles, a lot of hit or misses as we've gone through our careers. And so, what are some of those kinds of things that you would, you know, you mentioned, one, what you would share with your younger self, but what are some lessons or things that you would encourage ones that are starting out, to to embrace,

Unknown: 23:35

I would say embrace, learning, embrace, knowing that you don't know everything, I think that it's okay not to know everything, and to show up and work really hard and try things. I think the other thing that's very important for people coming into our industry is failure is a big part of what we do. And understanding how to manage through that yourself is going to be very critical. I know. And I don't know if other you're like this or not, but I'm very critical of myself. And I have a very strong, loud inner dialogue that I often have to silence. And I think the earlier you know how to manage that, the more success you can have. I think the only other words of wisdom is don't be afraid to ask for what you want. It also took me a really long time to really be able to articulate what it is I need and how that shows up either at work or at home. And I think that that I wish I knew how to do that earlier on in my career.

Dori Gonzalez-Acevedo: 24:38

Yeah, so this is a very interesting topic because I think, for me, as I've learned, similar to you, I've had to figure out how to ask for what I need over the course and it's been more recent that I've gotten better at that. Right. However, I my experience is that's often synonymous with it. Women neediness. Right? If a man were to say the same thing that I've asked for, it wouldn't be stocked twice, right? But we might, I might have to ask multiple times for that need to be met in order to do whatever it is, right. And that's gets tiresome. For me.

Unknown: 25:29

I think it gets high, it does get tiresome for everyone. But I think there's this element of what I call like relentless pursuit. Right, if you know that you need it, if you know that you need it, there has to be a way for you to have it. And it's trying to figure out what that looks like for you. You know, I think it's, it's more and more light is being shed on diversity, inclusion, women, the diversity of thing is being brought to light. And that that really is important. So I would just say don't give up to all those people that feel tired over it. You know, I know, I didn't, it wasn't easy. Like you. It was like, Oh, my gosh, I have to ask again. You know, you do it, and you ask for it. And then eventually, things have a funny way of presenting themselves for you. Yeah, I got the

Dori Gonzalez-Acevedo: 26:24

you know, I like that relentless pursuit. Right, that that's what she said, I really liked that, that. And, but what I also hear and what you're saying there is that it, the end result is important, but maybe not necessarily how you get there, that there might be multiple ways to get to X, Y, or Z. Right. But it is that your that that whatever that end is, is a non negotiable. And I know that's something that also I think I work somewhat with some of the quality teams that I work with is right is, you know, you might have all these desires of what the ideal process is, or, you know, and how it should, should be right. But there are only a few non negotiables in that process, right? Let's figure out what those non negotiables are. So I take that just not just from a personal kind of, you know, what I need from a career development perspective, but also from my strategic help with customers, right? Or clients, right to really try to hone in because that wish list could be really long. Yes. Not possible, right? There's not it's just, you know, those are nice wishes, but there are must haves in there, the ones that are totally non negotiable. And there's a bunch of like, oh, yeah, it would be really cool if it did this, or, or we had, you know, five, five additional reviewers or whatever those things are right. But does it really, is those absolutely critical to the critical quality attributes that you're talking about? Right? And so what are the non negotiables? In there? I try to apply that to my personal life as well. Right? Not everything can be.

Unknown: 28:17

Yeah, but that comes back to the the concept of, we have to get some things done, and it's not going to be perfect or perfect by your definition. And so how do we make that, okay? And how do we still manage the business needs and the business goals, because that's what we're all here for. We were all there. And even today, we're all here to bring these new medicines to patients. They're waiting for us they need these medicines. So we have to come come back and be grounded and what's really critical.

Dori Gonzalez-Acevedo: 28:47

Yeah. So I wonder what you think of it, you know, from a result of COVID. Right, I think that some of this kind of release of perfect, has been unleashed a little bit. Do you experience that as well, that there's kind of been a the ability to let go of some of that due to COVID? Or no,

Unknown: 29:11

I think this is my opinion, I think that it depends on also where people are in their careers. I found interesting, and, yeah, so I found because, you know, if you think about how we're trained, we're trained, if it's not documented, it's not done if it's not, in a procedure, you can't do that step. It's very prescriptive. There's all these very prescriptive training, and rightfully so. But that thought process evolves as you get go on in your career, and then you'll hit this pivotal point where you're, you're really challenged like, oh, gosh, is do I really need this or do I not really need this? And that's where you start having these meaningful conversations about value add, about what what are those non negotiables so I've seen it very interestingly across Is the spectrum and and felt it differently depending on sort of where people are in their careers? I mean, I know that's sort of a general statement. But that's one observation. And I do think there are just some people that are wired. Right. We're type A, and we have to do it a certain way. And we have to have those conversations about the non negotiables.

Dori Gonzalez-Acevedo: 30:20

Yeah. So I've been reading a lot about millennials, and just in the different mindset that they come into, right. And one of the things that's striking to me about the next generation is round, the wanting to participate more in that, that that critical thinking sort of thing, like throwing ideas out, you know, and being a lot more, if you will, curious, right around? Why did, why are we doing it that way? Right, and really challenging? The status quo. Right, and being vocal about that. So I you know, when my first start, I don't think I was that vocal about bucking the system, if you will, right. And I think that I wonder, you know, if this is one key element difference that could help in the transformation, as particularly, you know, life sciences tend to be slow to change, slow to transform. And I'm curious if you have any thoughts around that?

Unknown: 31:25

No, I do think that's a really great observation. But what I think it does is it changes how we lead, and it changes how we show up as leaders. But more importantly, it changes the expectations of those around us. So let's say we have a team of directors, what do we expect of them as mentors and coaches? And how do we get them to work and partner and lead and engage? I know, one example I can share, I had to do a strategic plan. And my team were all dig various levels, they've had some experience with it to no experience with strategic planning. But if you just walk away, if you release it as a leader and just say, what do you guys think? Why don't you come here? The boundaries? Here are the parameters here a few expectations? What Where do you think we need to be in 18 months? What are your priorities, and you sort of let that team have that dialogue? It's unbelievable what they can come up with. So it's also about being a leader that's able to release and let go, and then setting very clear expectations of we're going to have these conversations around mentoring and coaching. I'm going to do it, you should expect it of me. And if I'm not, please tell me, because I'm also open to feedback. And then how do you engage with your staff and those around you? Because there are people that want that? And I think that's a big factor for employee retainment.

Dori Gonzalez-Acevedo: 32:47

Yeah, I was just putting together another talk that I'm going to give this afternoon around employee retirement and some of the key elements here, I think you've hit on them. Right. It's really the wanting to be heard. That it's as a reciprocal. Nature, right. Versus and dictator sort of approach, right, there's really wanting to be the go go between and dialogue across the board. I think that that it's hopeful to me when I when I chat with folks like you right, like, because I think that the that leadership skills, net, that you as a strategic consultant will come in and share with most is very inspiring. Right. And I think that that's helps set the precedent for more to let go of that perfection or let go of the old ways that they've thought that it should be right, and let go some of those shoulds. What are some of the things that you'd like to to do with folks in terms of change, you know, helping have that conversation with their teams? Is there anything that you try to do together?

Unknown: 34:03

So what do you mean? How do I encourage my team to be coaches, mentors? Yeah, yeah. Yeah. So I think, I think it's just my own style. So I do it, I do it naturally, I do it with just my team or those people that are around me, because I care about them. But I also, like I said, try to do my own level skip levels are trying to meet with their staff. And for those that are new in that mentoring, sort of coaching space, the skip levels are really critical in that it helps me guide.

Dori Gonzalez-Acevedo: 34:36

What do you mean by that? I've never heard that name before. Oh, so

Unknown: 34:40

let's say I have an organization of three or four directors that then each have their own staff. So I would go down into the organization and meet with each person and do that on a regular basis. So again, it's that personal connection. So if they have direct questions about the vision and the strategy, any feedback on wherever they want the work to go, they have a voice and it gives the whole team a voice. I have to be careful with these because you want to respect the direct line of leadership. So, you know, it's it's a skill that you have to acquire, I think over time. And one, you know, like everybody else, I'm a work in progress. So I'm sure sometimes I get a right sometimes I get it wrong. But those conversations then helped me come back to my team and say, All right, how are our check ins going? How are we doing with the development? Does everybody have a professional development plan to people feel like they have been shared opportunities? Or, interestingly, as I learn of new things within the organization, I can talk to their direct manager about and say, Hey, I heard about this opportunity. There's a big project coming, do you think so and so would want to sit on it. And then they have to go back and have the conversation. So it's really about knowing who you're working with, what their interests are. And then being comfortable having some conversations with your direct reports and your team about, Hey, these are all the new opportunities coming? Who's going to who wants to raise their hand?

Dori Gonzalez-Acevedo: 36:10

I like it. Yeah, so I think the heart of what we're also saying is that the old, old school, if you will, right, leadership styles are not going to cut it anymore, right? And that leadership, particularly in the quality area, need to change and transform. And so what are some of those? If we get back to industry specific things? Like do you have like one or two things that you wish for, you know, quality leadership and life sciences to kind of embrace as, as we move forward? Here, there's, you know, the validation 4.0 form of for portrait, there's a lot of change and things that we again, as a broader industry want to see happen, what are some of your things that you'd like to see happen?

Unknown: 36:57

So I think, given that I work in this sort of small to mid size space, what I would really like to see happen is an evolution of what people think quality is, I want to see a transition from something that's operational or tactical, to really a competitive advantage for these companies like, so the leader, the quality leaders that can come in, have this opportunity to influence culture, they have an opportunity to influence the business strategic plan, and then they have the opportunity to actually build out their infrastructure, because you need that technical knowledge. So I think this evolution around quality into sort of a compliance mindset is going to be really key. Because as you know, we're highly regulated. And there is this whole host of compliance that comes up under ethics and all of the policies there. So being able to see it, as a real partnership across the business and all of these different areas is is something that I would love to see evolve.

Dori Gonzalez-Acevedo: 37:57

Great. Is there. So the connects community, were the women needing validation? We kind of started that off. We've have mentoring mentees, we've, you know, talked about sponsoring, you know, do you recommend where someone should start like mentoring men, you know, sponsoring? Like, what? What are some of your suggestions, if if someone hasn't yet gone out? What should they do and try to find help and support?

Unknown: 38:28

So if if someone comes to me that is looking for a mentor? Yeah, so I think these things are so personal. To be honest with you, I think some of these smaller companies, they try to roll out these types of programs where there are mentors and mentees and they become a little bit more official. But I think you need to just have a genuine connection with someone. And the mentors. And I'll just speak from personal experience, the mentors that I've had, I didn't I didn't go up and ask them like, Hey, will you mentor me, it just happened. They were they were thoughtful, they really cared about me. And they just gave me real honest feedback. And some of it was painful, and you don't want to hear, but that's what makes a good mentor. So when I'm working with people that are looking for that type of relationship, I always tell them like who do you go to for advice? Who is the first person they're going to call? And maybe there is a way for you to establish a more routine check in with that individual. There are there have been times where people have had a good relationship. And if approached me personally, or I've approached others and said Hey, will you be my mentor? And they said yes, but I do think there's something a little bit more personal, I suppose about it, where you, you need someone that can appreciate you and understand you for who you are and point you in the right direction. So I always say, Who do you Who do you go to was your go to person and maybe they become your mentor? You're cool.

Dori Gonzalez-Acevedo: 40:02

So as you embark on your next phase here, what are you looking forward to?

Unknown: 40:08

So I, as you know, I just started my own life science consulting firm. I'm really excited about all the future product projects and meeting new people. I think that's the thing I'm up to be honest with you that most excited about is meeting new people and trying new things, I think is you've probably learned here, I'm not afraid to say yes. And I'm willing to jump in and learn how to navigate new challenges. And I love working through complex problems with folks. So those are the things that I'm excited about.

Dori Gonzalez-Acevedo: 40:36

Cool. Very good. So Katie, I think that's a wrap. I really appreciate your time today. I know that time is precious. So I thank you much gratitude for sharing your thoughts and insights with women leaving validation, and it will be published in a couple of weeks.

Unknown: 40:56

Great. Thank you. It's been wonderful being here. Thank you for your time. Absolutely. Okay.

Dori Gonzalez-Acevedo: 41:03

All right.