Inspection Readiness and Quality Systems with Jennifer Vavala

Speaker A: On this podcast you'll find interviews with high performing successful individuals in life sciences on a weekly basis. We cover their proven methods, principles, strategies and mindsets to implement new technologies that scale to meet the needs of people in our world.

Speaker B: Welcome to this episode of Life Science Success. For those of you who don't know me, my name is Don and I'm a digital marketer in life sciences. And as we get into our interview today with Jennifer Vavala, she is a founder and principal at AlignPoint, uh, partners with more than 27 years in pharma, medical device and diagnostics, leading QA QC in complex regulated organizations. So with that, welcome Jennifer. It's great to have you on.

Speaker C: Thank you so much, Don. I'm really honored to be here. Thank you for having me.

Speaker B: Yeah, it's great. And I mean, what I like to start these conversations with is just a little bit about you. I mean, you've got this long history in QA and QC that I mentioned during your intro there. Um, would you mind just spending a little bit of time telling us about all the different segments? I mean, it's funny to me because whenever people look at me they tell me, you know, hey, look, you're a generalist in life sciences because, you know, the fact that I've touched pharmaceuticals and medical device and at the same time like, yeah, but I mean, what is a generalist in life sciences? But at least you have a specialty.

Speaker C: That's fair. Um, I think what got me into life sciences was I graduated with a biology degree, um, and I was lucky enough to have an internship that was a professional internship at the microbiology lab of the Hershey Chocolate Factory back in Pennsylvania. Um, but that gave me some real world experience, um, and I was offered a job as a microbiologist at a pharmaceutical contract testing lab. And it was a natural fit for my background. I loved micro and I really loved, loved the lab. Um, and kind of what drew me to life science, um, outside of micro was really the complexity, the intersection of quality compliance and execution. It really matters. And misalignment, um, does have real business, um, implications. But across my career and all of the, um, you know, the, the medical device, the diagnostics and pharma, it was always consistently close to that execution of quality compliance and delivery. And I saw firsthand how those organizations operate under pressures and somehow I survived almost 30 years.

Speaker B: In terms of the, the things that got you into it, was it more the growth side of watching something grow in microbiology? Was it something like, you know, maybe there was something interesting in the science, what was it, you know, overall that was more fundamental that that got you into it?

Speaker C: I mean, I think I've really always been, I'm like, I love being outside. I, uh, have field guides all over the place. Bugs, birds, you know, things like that, plants. And I just like the unpredictability that the microbiology lab was assessing those living organisms. And you had to respond in a way to a living, uh, thing that you didn't really know how to control very well. It wasn't chemistry, it wasn't black and white. So I liked being in the micro side of things that offered a little bit more flexibility and insight into trying to control processes around something that really had its own agenda, if that makes sense.

Speaker B: Yeah, it absolutely does. I mean, I certainly like that side of it myself. Um, but I certainly have, um, met people that are much more, I guess, interested in what could I look at under the microscope versus how does life tie together. Um, and so I just really wanted to hear how that tied together. When you look back at your, um, career in moving through operational QA and QC leadership roles, um, what were some of the pivotal things that you went through in your career and what was it that really brought you to where you are today?

Speaker C: That's a great question. Uh, for me and what I'm interested in now, it's not a single moment or two that I can really pinpoint. You know, over my tenure it uh, was a pattern that really emerged over time that I really couldn't ignore. So beyond the quality and compliance aspect of what I do and you know, from the laboratory, it was a normal evolution to kind of get to that broader quality and compliance umbrella. You know, the longer you stay in your career, rarely do people stay just in a laboratory their whole time. Um, and that was a natural progression for me. Um, but as I across my different roles and organizations, I really kept seeing strong teams working incredibly hard to maintain performance. Um, but they were constantly absorbing increasing levels of compression. You know, deadlines got missed or there was expensive rework. So the pattern was the issue was not capability, it was really capacity. And what was being asked of a lot of organizations and teams has really outpaced what the system can realistically support. Um, and I'm sure that you've seen some of that in your experience. It is not uncommon for just one day, one example at a life science organization to have to juggle many different things. Unplanned downtime, non conformances, human capital management, a rigorous compliance expectation like Annex 1 shows up. You've Got to fill gaps left by a regrettable departures, improve vendor client relationships, support new business opportunities, implement continuous improvement, you know, and not to mention what's coming tomorrow and you know, auto findings and inspections and you know, all of this in my lifetime has really under this do more with less operating model that has become very normalized.

Speaker B: Yeah, yeah. And I think, I mean it's, it's interesting to me because um, like some of my greater mentors on the quality side of things, um, I felt like always approached it as, you know, one, you have to build a system that you actually think that you can live within, um, as well. Right. I mean certainly don't build something that you don't think people can follow because it'll just lead to more findings and more issues for you later on. And um, yet at the same time this whole idea then of like, okay, so let's do that with a few more, few less people, you know, checking things and a few less people documenting stuff and a few, you know, and then eventually it sort of leads to the same sort of, you know, challenges. I feel like on the opposite side.

Speaker C: I totally agree with you. And you know, some of the other things that shape how I think about quality today is under the, in those environments, um, when the organizations are being compressed, you have individual leaders and individual functional units trying to be successful, using different workarounds, their version of reprioritization just to keep things moving, but it's not cohesive and it really does impact decision authority, deliverables, compliance. Um, and really quality is really dependent on how the entire operating system is structured. Just like what you had said.

Speaker B: Yeah. And then heaven forbid that you have, you know, an oversight activity, whether that's an internal, you know, internal auditor or um, you know, even an external, you know, ah, audit from the FDA or somebody else, you know, like that as well. Um, you know, I just, I, to me, I could only imagine the stress that quality leaders go through. Um, I've only done, I, I only my quality, my quality spent, I want to say was like, I think somewhere between two and three years. And then after that I was like, yeah, this isn't really, this isn't really a spot I could see myself in long term. But yeah, so that's for how people manage it, right? Exactly, exactly.

Speaker C: You bring up a really good point because often it's put on the quality and compliance leaders to have to make sense of the um, the chaos really behind it and present to the regulatory bodies a, uh, very well controlled, you know, organization that is operating, you know the way that it's intended. And the reality is a lot of tap dancing around that because that's not what you're living day to day. And so at that time to go through exercise in front of a regulatory inspector, it, it can be a little nerve wracking sometimes.

Speaker B: Yeah, I could only imagine. So let's talk a little bit about your experience across pharmaceutical, medical device and diagnostic manufacturing. Um, I kind of think about all three being, you know, very different regulated worlds. But at the same time I'm sure they have their similarities. Um, with that experience, you know, how do you think about um, you know, how, um, you know, how to manage each one of those uh, sectors.

Speaker C: So you're right. While the sectors have different regulatory frameworks, um, my experience is the underlying quality requirements are surprisingly consistent and really patient safety is at the center of it all. And I think that's what keeps a lot of us, you know, in the life science space. But that breadth of experience has exposed me to many different environments. And you know, really what I have seen, regardless of the product, regulation or organization, um, is some of the same patterns that emerge, you know, when the systems need um, to make some adjustments or having those operational strains. Yeah. And I think on that, if you'd like to, like a little bit.

Speaker B: Yeah, I mean, can you tell us a little bit about how. I mean, because I would imagine you're probably seeing some of the things that I see as well. Because with, I feel like with personalized medicine, you have diagnostics playing pretty closely to pharmaceuticals, you have um, certainly medical devices that play, you know, really closely across, you know, as well. Um, are you seeing that, uh, in the industry, you know, as well,

Speaker C: seeing, um, how they all link together? Uh, yes, yeah, yeah, I definitely, I see that. And a lot of um, organizations are trying to be everything, you know, and they're trying to adopt a lot of those models. Um, it is a little bit different when it comes to operational execution because there's fundamentally differences between laboratory operations and manufacturing operations. Um, but I think the synergies that are happening are because people are moving around within the same models. You know, if you're in a quality, you can, I can run a quality system. So I'm going to be able to maybe extrapolate that and go from pharma to medical device or diagnostic and back and forth. Um, and that's what I've been able to do because you know, the, the regulations are there. But um, it's really a system that doesn't differ across all three very much. And so you are able to apply those and have some of those similarities and become marketable across those three different segments.

Speaker B: It really helps because I, I, I know I've seen people in different organizations that I've been in where they, where they certainly do that. But at the same time you, a lot of times you'll see somebody really specialize in, hey, I, you know, I help diagnostics companies work with, you know, pharmaceutical companies, you know, to translate, you know, their diagnostic to, you know, more specified answers related to uh, you know, what the diagnostic can provide. And I mean at the same time it's you know, mentally. I, uh, just, I would imagine it takes a special person to sort of say, hey, look, let's just sort of bounce back and forth between all three.

Speaker C: So yeah, I think for quality operations it is easier than the regulatory personnel. Right? The regulatory people are really have to be a lot more specialized. But as far as, you know, the day to day operations and getting the data or the products to the patients or out the door, that to me is a little bit more stable and across those three platforms as opposed to the regulatory strategies that I think are different and require that that different level of niche expertise in order to be successful.

Speaker B: That makes a lot of sense. So, um, can you tell us about the work that you're doing right now and what is the mission behind your company and uh, how is it that you lead teams in life sciences and manufacturing environments?

Speaker C: Sure. So at AlignPoint Partners, I work with life science organizations to stabilize execution under increasing operational pressure. Um, in these environments, uh, compliance and delivery risk, they don't really come from a single source or a single failure or risk. They really build upstream when demand exceeds capacity and that strain gets absorbed over time. So my work makes that misalignment visible. It drives explicit trade off decisions at the leadership level, uh, puts governance in place so that execution is stable and it's not dependent on overextension or informal workarounds.

Speaker B: That's helpful. And then also I saw that you developed something called the Operational Stability Recalibration Framework, um, which is a fascinating concept. Can you tell us what um, it is and what problem does it solve?

Speaker C: Absolutely. So let me first define the operational stability. And this might be a little bit of a lengthy answer, but I'll do my best to kind of pack it all in here. So operational stability is really the ability of an organization to constantly meet its commitments without relying on unsustainable effort. So in life science organizations, especially ones that are investor pressured, um, we're routinely asked to deliver more than we are structured to realistically support. Um, it is an underestimated risk that is showing up across the industry from multiple angles. You might hear conversations of operational leaders talking about, um, overload, burnout, incredible talent loss, or you have QA leaders talking about oversight gaps and decision logic and investment. Investors are talking about execution risk and failed transformations and consultants are talking about repeat issues requiring third party interventions. Um, but operational stability recalibration is a structured framework to fix these gaps. It intervenes to address sustained, sustained delivery pressure, flipping commitments, um, increased deviations, rework, inspection, exposure and teams that are operating beyond their sustainable limits. Um, it was created from seeing the patterns that I have seen across different organizations, um, with the same structural issues. Um, and it can be really valuable in investor settings because if you really want to understand where delivery and compliance risk will surface 60 to 90 days post value creation, um, operational stability is often where it starts.

Speaker B: And so does it look at like the capacity of those roles or is it more like the scope and boundaries of the roles?

Speaker C: It's a little bit of both. Um, the tool is a simple model because of what I didn't want to create was something that was going to be complicated for already burdened organizations to try to have to wade through. Right. So it's a four pillar system that really starts with the operational, uh, strain diagnostic and then there is in a mandate to capacity alignment section. Then there is governance, um, uh, and tools implementation and then there are sustainability guardrails. So the diagnostics in the mandate to capacity alignment portion of that will um, evaluate if a capacity analysis exists for certain organizations. Um, and that is a part of what we do. But some of the other things that I was seeing is an organization might decide that they need to go through a rif, right? And maybe that RIF is going to be handled by human resources or a uh, small discreet leadership team for obvious reasons. But they're going to make those decisions maybe in a vacuum without capacity analyses and really understanding these certain things. You don't know where you're overloaded, you don't know where you can take those risks with human capital investment. And you don't really maybe appropriately know you might go based on bias of maybe poor performers, even though that shouldn't happen. Um, and you know, in the state of California you're at risk of not being able to refill those roles for another year, um, after you maybe make those positions, after you make those positions eliminated. And it's not uncommon to maybe go through a rift and the business Might turn around and then you're going to get three new clients and then you have a new regulation that you need to, oh, and the FDA showed up and somebody's um, going out on leave, you know, and then you have all these other compounding strains. And um, I think the issue is that at the executive level the day to day operations aren't really revisited um, at the executive committee meetings. So there are informal trade offs and some of those prioritizations are left to the individual leaders who ultimately don't have a lot of control over what is really being asked of the business. So the capacity is a small part of it, but some of it is like if you're going to ask them to do this, then what can be maybe delayed, uh, maybe we're going to delay implementing a new system requirement for a couple of months just to give us some breathing room. Sometimes it just is evaluating those trade offs within those organizations, um, so that the leadership at the manager and director level are not constantly operating in a chaotic state like kind of playing whack a mole. So um, they can stabilize and lead their teams a little bit better as well.

Speaker B: So how do you help organizations recognize um, the tipping point of um, escalating mandates before ah, compliance or delivery risk becomes visible.

Speaker C: So a lot of my work helps teams that have already reached that tipping point. And the good news is that it is a recalibration. So it does include implementing those guardrails and metrics to prevent regression. So it's not always proactive but that would be the ideal way to go about it. Um, but you know, it's difficult because most organizations don't immediately realize, let alone recalibrate because the instability happens quickly, quietly and it compounds over time. Right. There are early signals and some we have already discussed like mandate, you know, capacity expansion, uh, priority inflation, you know, um, excessive meetings. But others include like lack of decision clarity, reliance on heroics to meet deadlines, excessive use of overtime and that uh, ever repeating pattern of well we didn't do it right the first time so we're going to do it right the second time. Right. So the work is really about making the risk visible in a structured way so leadership can see those risks and take actions before it shows up as something more serious or it really continues to compound. And the diagnostic framework, um, it helps do that and it does a bit of a deep dive with all of the GMP functional units, specifically in the regulated life science environment, supply chain operations, quality, qc, you know, manufacturing, um, and it brings to light what Everybody is really dealing with and addressing with and seeing what you can reasonably accomplish within the structural, you know, funding of the

Speaker B: organization makes a lot of sense. One of the things that I know most organizations probably don't like to think about, especially early organizations, is that inspection readiness. Um, so how do you help companies get, you know, ready for regulatory inspections? And what separates companies that are truly ready from those that are just going through the motions?

Speaker C: I think that's a really good question. Um, I think one of the biggest things that I see is that organizations are still preparing for inspections with surge effort and the burden is primarily put on quality and compliance. Right? There's a lot of effort around storyboarding known issues, preparing SMEs, performing walkthroughs, gathering documentation, and they're all very important. Um, but attention is rarely given to how the system is funded to operate. And the metrics may even be green. Right. I think we see that a lot. But, uh, underneath the system is buckling, uh, under compression, um, and that may signal in quality and compliance, uh, but it's really a foundational issue. So I think the other complication is some of the strain and the inspection readiness. Um, it's not really talked about, it's not visible in formal GMP records. We don't document things around resource decisions, expectations, priority setting, but that is really how the system operates. So there becomes this disconnect, right? Um, so the companies that are truly ready where execution is reliable and stable, they understand what it takes to deliver across all functional units and support the organization appropriately. Um, since inspections are primarily retrospective, by the time you have an inspection and threads start being pulled, your risk is already imminent. Right? So companies in real favorable positions, they can prove their monitoring be on playing catch up and identifying passive trends, right? They can prove they are looking ahead and ensuring their regulatory commitments and growth are aligned with capacity analyses to reliably deliver. I think a lot of organizations really look at, uh, expansion and growth and the regulatory commitments are always there. Whether you make one batch or you make, you know, 15,000 batches a year, you're still bound by those same things. And a lot of headcount decisions and a lot of resource decisions are made based on the level of business, right? And so they wait to, uh, we'll wait to, you know, realign that when we have, um, a new project or we have a new client or we know that we're going to get this funding, um, and then everything happens at one time and it just becomes a very disorganized approach at aligning Those capacities and expanding your business model.

Speaker B: Yeah, yeah. I mean, I, it's funny to me because I remember like the very first. Very, really small. I mean, I worked for General Electric for a number of years and then also for, uh, Becton Dickinson for a number of years. And, um, certainly we knew how to handle regulators, you know, inside of those larger companies, and you just had a structure and a flow and, you know, everything just came together. And I felt like, you know, we really, we really knew, you know, like when there was a regulatory visit, like what exactly, you know, things were going to play out to be. But being in a small organization and seeing, you know, what they go through, it's kind of funny because, I mean, I remember leveraging some of my past experience and just saying, hey, you know, I think we need to have a front and room and a back room. We need to prep people. We need, I mean, uh, to your point, like, I mean, the, the moments of the, um, the events that would or would not get us in trouble, uh, with regulators were already over. Now it was a matter of sort of figuring out, like, how are we gonna, are we gonna phase the evidence into the room? How are we gonna, you know, tell the story? How are we gonna, you know, share everything that, that we've done? So.

Speaker C: Yeah, yeah. And I think the regulations are kind of. Well, the regulators are getting to the root of evaluating how businesses actually operate. Right. That's clear in some of the warning letters and those signals that are emerging right now. And I think they're all pointing to this structural instability. If you look at the warning letters, if you look at the 483s, uh, they haven't fundamentally changed in 30 years. So then you wonder, well, what are we not looking at? Or maybe what are we not asking? Are we not asking the right questions? And I've had some conversations with ex FDA inspectors, um, and they agree, you know, they just. Within the rules of the regulations, they're, they, they're not really permitted to dig into certain aspects of how the business is funded. And if the executives really, you know, what it takes to execute and if this leader, you know, does this or. But now they're really signaling that whoever pays the bills and allocates resources will be signing the 43 responses. You know, the, the draft guidance that are emerging, emerging around FDA expect expectations, uh, as well as some of these warning letters are, they're clearly putting it back on the executive committee or, um, the leadership team to really support the business. Um, and it's, it's not just A quality and regulatory, um, compliance, uh, activity, like I said. And I really think that they are trying to do the best that they can within the confounds of what they're allowed to ask to get to the bottom of, uh, why do we. Why for 30, 40, 50 years or we keep seeing the same things happening across these organizations. I mean, really, uh, different products, different organizations. The themes are very similar.

Speaker B: Yeah, to your very good point, I mean, I've heard, I've heard quality people before stand up and say, hey, look, you have to do this or this to be, you know, kind of these regulatory requirements. And then on the opposite side, I've seen the executives say, but, you know, look, uh, if we do that, it's going to cost too much. It's going to be, you know, we're going to spend too much money. And so there's, I mean, there's definitely this push and pull. But then I've seen on the opposite side, like if you get a 483, um, or heaven forbid your product at some point is stopped because, you know, you haven't listened to the warning letters, um, you, um, all of a sudden are in this situation where you'd almost do anything to get product flowing back out the door. And it, to me, it's, I don't know, take your pain now or take your pain later.

Speaker C: That's what I was going to say, the pay now, pay later model. And it is still amazing to me. Um, oh, we'll just deal with that later if it happens. And I know it's kind of the wrong way to say it. Um, you're supposed to say, we'll cross that bridge, we come to it. But it's become, we'll burn that bridge, we come to it. Which is not really the right approach because you might have taken the, the need for, let's say, broad strokes, one or two headcount, and now you're in a 300, 400,000 million dollars remediation situation. Um, it is amazing, the pay now, pay later model. And a lot of organizations would rather, um, pay later. And um, I think a lot of, a lot of pain could be mitigated and a lot of inspection outcomes could, could be more, um, favorable if they really did some of the upstream assessments on the processes and how that's going to impact the downstream. And really, very few organizations are keeping metrics around these things. Right. And monitoring this type of performance. And by the time it shows up in an inspection, well, that could be years of neglect on a particular issue. Right. It could be, you know, months or weeks or years or. It's a known issue, no doubt. But you don't apply the five whys and the root cause analysis to these 483s. Right. And if you really did, you could probably start untangling, you know, some of the, the yarn and get back to some of these upstream issues that are really impacting the downstream risk.

Speaker B: I mean, it's one of the things that ran through my, through my mind just as you were answering that as well, that given all the stuff that's going on with AI, I wonder if anybody's spending any significant time examining that. But, uh, yeah, you'd be interested in that.

Speaker C: Go ahead. Yeah, I think AI just, uh, should be. You should use your discretion when implementing AI. Right. If there's a unstable system, uh, maybe you're going to be pencil whipping investigations or your root cause analysis isn't robust, or your governance, uh, and authority decision logic isn't well known. And you're going to implement some AI models into these already strained systems. It's going to potentially amplify the undesirable noise. Um, and so I really encourage a recalibration before adopting AI, just so you can really see where you need it and what you want that outcome to be. So you bring up an excellent point. I didn't mean to talk over you there at the end at all, but you're absolutely right. Implementing AI in an unstable system can be a pay now, pay later situation. And it, um, there's a real danger because everyone's like, oh, well, this is going to prevent us from, you know, getting more resources. You know, we, we need to implement AI and we need to do this. But they're implementing it at this rapid panic level pace without really evaluating where it's going to support their organization the best.

Speaker B: Yeah, yeah. I'm more interested in knowing though too. If somebody were to apply, um, AI to examine all of the 43s, let's say, in the last decade, what would the outcome, you know, be in terms of lessons learned? And maybe there's, um, I don't know, maybe there's a big aha moment there. But I also think, I mean you kind of think about some of the things that you see in organizations and I'm sure you've seen, you know, a lot, you know, throughout your time, as have I. And I just sort of think about like some of this stuff is just, I mean, it doesn't take rocket science to figure out like why. I mean, we've had to. Your Point just a second ago you had said something like, you know, you see the same repeat problem and it's not resolved. And I sort of, you know, like at that point, why wouldn't somebody spend some time to resolve whatever it is, you know, is a key question. And I think whenever you read some of these 483s, you kind of go, okay, well I mean why couldn't you, you know, document and qualify this better before it, you know, before it got this bad?

Speaker C: So yeah, absolutely. And I just had a discussion with um, a couple of ex FDA inspectors. Two different conversations around this topic. And you know they're humans too, right? And they're involved in the process with their subjectivity, their areas of expertise, you know, to further compound kind of what you're saying, I've gotten some feedback that if agencies could do that kind of data mining, but around the inspectors, um, like know your audience kind of a concept, um, it would be a much more favorable outcome. But it's really challenging to get that intel that regulatory intelligence doesn't just come from that. Um, they might come from the inspector individually. Like they're going to bring a team of three people. You can look and see what this one, this one and this one. You know, what their trends are. But um, they really come from an inspection family like at their office that they work together with and they bounce ideas off each other, they get familiar with each other and then they become like their own ecosystem of experts expectations. And I'm not saying that's right or wrong, but it's really challenging then for an organization to prepare and tailor a message around retrospective things to specific inspector teams. Without that 483 data mining, AI intelligence, the complete response letters were redacted and it was really hard to really get to the theme of what those were going to be to help organizations. Um, and oftentimes inspections are unannounced. So there are limitations I think on both sides. And I totally agree with you. And knowing that there is that human component in the inspection with their uh, expectations, um, it's a wild card. Every time you kind of go through an inspection without this level of information. It's a nail biter until the end because you just don't know. You just don't know.

Speaker B: Absolutely. So how do you see the role of quality leadership evolving in life sciences over the next several years? Um, especially in manufacturing environments become more complex and regulatory expectations continue to shift?

Speaker C: Yeah, I love this question. Um, I see especially quality evolving from being a required headcount to a strategic Business necessity. Um, but many firms still follow the quality is indirect labor. And we're going to apply a percent to the workforce because we have to.

Speaker D: Right.

Speaker C: You know, they not, not again, not fully understanding what it takes to do things. So, um, as things get more complicated and more complex and things evolve, it's not just about assuring compliance. Right. This is a given. It's about understanding whether the system can sustain what's being asked of it and doing risk intervention at the earliest point. So quality leadership is shifting towards m, helping organizations make better decisions around capacity priorities and risk and not just be there as required oversight.

Speaker B: Yeah, yeah. I mean, I think about that though. I mean when the more that you have, um, indirect labor managing this side of it, I mean it's gotta be hard as well just to m, like have a complete picture and a complete understanding of what's going on. Um, and I certainly have run into a lot of very junior, um, people that, you know, are both on the quality and regulatory side, you know, trying to do what they can. But at the same time, like, you only, you only have so much experience, you know, at given points in time, and it really requires somebody to understand kind of the ins and outs of what might really get you in trouble as well.

Speaker C: I think you bring up a really good point because a lot of organizations equate, um, you know, butts in the seats and the headcount with, you know, we have, we have enough qa, but because of some of the sustained pressures and because of the, some of the chaos of the day to day, a lot of people are leaving certain organizations and they're moving around so that talent retention, that knowledge management is missing. And so now you're left with, maybe you're, you're funded to have 15 QA people, but six of them are new hires at level ones or twos, right? And then, you know, the remaining might be actually able to do what you're asking. And that's seeing what do we really need to execute on a compliance level. And um, by doing these recalibrations and assessing this upstream risk, it really does have a positive, um, it has a positive side effect, right, on the culture, on the talent retention, you know, things, cohesive leadership, you know, things are running smoother. And so there are other impacts beyond this that are. Even though it's not the normal OPEX and performance management type of, you know, partnership with organizations. But you're absolutely right. You, you can't just say we've got six people, you know, we've got 15 people in quality, how did this happen? Um, what is the capability of those individuals? And if a senior person leaves, I know a lot of organizations that will replace that with a level one or two because they want to save the money. But again, that becomes a pay now, pay later type situation. And that compression keeps piling on the existing tenured and experienced people that stay, and it's just a matter of time before they can't continue to operate under that level of compression.

Speaker B: Yeah, absolutely. Um, so, Jennifer, what inspires you?

Speaker C: Oh, well, I mean, I think in the realm of what we're talking about, um, this really does inspire me because beyond the enterprise level and assisting organizations, what I really find meaningful is reducing the burden on management and directors who are often compensating for things that they can't control and they don't control. So I find the work inspiring, um, and really bringing that stability back so that performance becomes more sustainable.

Speaker B: Yeah. What concerns you?

Speaker C: I think what still concerns me is how difficult it is to become successful in these types of environments. And it is very normalized and how often sustained strain is normalized, especially in life sciences, where the stakes are very high. You know, the organization continues to stretch, um, but it's the individuals who feel that pressure and they then get evaluated against what is really a structural issue and the sustained tolerance for what they experience as chaos day to day has become a normalized performance expectation.

Speaker B: Yeah, it's interesting, um, that you share that though, too, because I feel like, um, the more that we just don't understand, like, what the impact of our decisions today could cost us, the more expensive they could be, I guess, down the road, to put it, you know, in one, in a different frame.

Speaker C: But yeah, yeah, yeah. I think, you know, adding certain things to risk registers at organizations usually become monetized, but certain things aren't translated into money. And I, and I think that you're right, you don't really know where all of your exposure is without looking at, um, all of these inputs that really influence how the business operates.

Speaker B: Yeah, absolutely. Last question. What excites you?

Speaker C: Well, what I find exciting is that this is really an addressable topic, um, even for those organizations who might have exceeded that tipping point like we discussed. Um, but once organizations can see where mandate capacity have drifted apart, they can make much more deliberate decisions, kind of, you know, what we were just talking about a second ago. When that alignment comes back, it's a real big shift. Um, and going back to those improvements, you know, positive side effects include predictive performance, talent and knowledge retention, cohesive leadership and operational stability. So I'm excited that even though it seems like it's a quicksand type kind of situation that a lot of leaders find themselves in, um, it's not complicated to kind of climb back out of that. I deliberately created the framework in mind with myself as a vp, Executive Leader of Quality compliance at a cdmo, which is one of the most pressure cooking type of environments that you can really be in. Um, and, and that's why it's called Align Point Partners. It's to partner with the organizations. It's not just say, oh, it's the normal consulting model. You have to do this, this, this and this. Um, um, it's different. Get them back on, on track and see where, you know, they can put some, you know, you know, breathing room back into their, to their individuals and their teams.

Speaker B: Absolutely. Well, Jennifer, I wanted to thank you for being a guest on the Life Science Success podcast. I greatly appreciate our conversation and um, you know, definitely would encourage anybody to connect with you at AlignPoint Partners. How can they find out more information about you or where would they, where would they find you? Online?

Speaker D: Online.

Speaker C: That's a great question. You can just look me up on LinkedIn. All of my contact information is there. Um, and reach uh, out. Send me a message, phone, uh, number, email. You can contact me that way.

Speaker B: Thanks a lot and thank you for being a guest. I really appreciate it. Take care.

Speaker C: Thank you for having me. Really, really enjoyed the conversation. Thank you so much.

Speaker B: Sure thing.

Speaker D: Thank you for listening to Life Science Success. For complete details about this podcast, including show notes, how to get in touch with guests and more episodes, please visit www.lifesciencesuccess.com. if there's someone you'd like for us to invite to the show as a guest, please let me know by sending me a message at the podcast website, please click subscribe on your favorite podcast app, share the podcast or tell a friend about it. And last but not least, rate the podcast.

Speaker B: Thank you again.