How the Future of QA Is Transforming from Compliance Enforcer to Strategic Partner

Let’s Talk Quality – Quality Unplugged, Episode 1

The evolving role of Quality Assurance in life sciences

Quality Assurance teams are at a crossroads. For decades, QA was seen as the compliance checkpoint — the group that ensured boxes were ticked and audits were passed. But in today’s complex, fast-moving life sciences environment, that approach isn’t enough.

In this first episode of Let’s Talk Quality – Quality Unplugged, NPG’s quality experts and industry leaders discuss how QA is shifting from reactive gatekeeper to proactive, strategic business partner. They share what this transformation looks like inside real organizations, and how QA leaders can take practical steps to get there.

Watch the full conversation below

Featured Guests

Host:

• Danielle Metzger, Associate Director of Quality, NPG – Leads quality operations at NPG with a focus on culture, collaboration, and practical solutions that drive sustainable compliance.

Panelists:

• Nicole Pederson, Vice President of Global Quality Assurance, Madrigal Pharmaceuticals – Brings more than two decades of experience transforming QA organizations into trusted strategic partners within the business.
• Christy Mazzarisi, Principal Consultant and Quality Leader, NPG – Works with global pharma and med-device clients to streamline quality systems and foster proactive quality cultures.

Key Insights from This Episode

• From reactive to proactive: Why the most effective QA leaders are moving beyond inspection readiness to embed quality into daily decision-making.
• Mindset shift: What it takes to build credibility across departments and position QA as a trusted advisor.
• Cross-functional collaboration: How transparency and shared ownership create a stronger quality culture.
• Small changes, big impact: Practical steps QA leaders can take today to evolve their teams’ influence.
• Strategic storytelling: How to communicate the value of QA to executive leadership.

Build a More Proactive Quality Organization

If your quality function is ready to move from enforcing compliance to enabling innovation, NPG can help. Our Quality & Compliance Services team partners with life-sciences organizations to close gaps, strengthen systems, and advance quality leadership across the enterprise.

Learn more about NPG’s Quality & Compliance Services. Or, contact us to start a conversation about how we can support your QA transformation.

Explore More Quality Insights

• Remediation Services – Rapid response and sustainable corrective-action support.
• Quality Case Studies and Whitepapers – Real-world examples of QA leadership and culture transformation.

Full Transcript

00:00
Hello everyone and welcome to NPG Quality Unplugged, the show where we dive into the world of quality, compliance, and continuous improvement because quality deserves a louder voice. I’m your host, Danielle Metzger, Associate Director of Quality here at Network Partners Group. In our episode today, we’re going to be discussing how the future of QA is transforming from compliance enforcer to strategic partner.

00:27
We’re exploring how the most forward thinking quality leaders are redefining their role to actively shape the direction of their organizations. In recent years, we’ve really seen quality leaders move just beyond the compliance silo and start having a voice in cross-functional strategy. But getting there, that doesn’t happen overnight. It’s a real transformation. It really starts with a mindset shift. From there, it’s about having the right people and systems in place.

00:56
And that’s what allows QA to become a real force multiplier for innovation, for speed, and for long-term success. So let’s dig into how evolution actually happens and what it could look like for your team. To help us look at this evolution today, we’re joined by NPG’s principal consultant and quality leader, Christy Masarisi, and our guest speaker, Nicole Pederson.

01:22
who is the Vice President of Global Quality Assurance at Madrigal Pharmaceuticals. Nicole is a seasoned quality leader with deep experience guiding life science organizations through transformation from development to commercialization. Our guests today have seen what it takes to move quality from being just a back office function and transforming it to being frontline strategic partners. Today, we’re diving into those lessons with Christie and Nicole.

01:50
Thank you both for being here today.

01:55
Thank you. Christy, you’re on mute, my friend. Oh, boy. Thanks. No, I say happy to be here. And thank you, Nicole, also for joining us today. We appreciate it. Thanks for the invite. Appreciate it. So to kind of kick us off today, we want to kind of look at why quality sometimes gets stuck as just a cost center, right? As we think about the future of quality assurance, it’s really important to start by looking back at what’s been holding it back.

02:23
So historically, QA has been viewed as the cost center, where the focus stays only on compliance, but that limits its functions, influence, and impacts budgets and can really affect team morale. With that in mind, Christy, let me start by asking you, in your experience, what happens to a team’s mindset and their morale when QA is treated solely as that regulatory checkbox? So that I actually…

02:52
have lot of experience in coming from industry and then being a consultant over the last 13 years or so, I always see companies calling quality the necessary evil, right? And we’re not, right? It’s not that regulatory checkbox. What happens to team morale is if they’re seen as that necessary evil, it’s gonna fail, right? Your quality culture is not being embedded, quality is not being seen as a trusted business partner, right? And that’s really our main job is how can we get in there as a trusted business partner?

03:21
We’re there to find efficiencies, right? ah Better ways to be compliant, building compliance from the ground up, right? So when morale drops, your engagement drops, and then you’re going to see higher risks come up, right? And compliance issues happening because the morale is not there and the engagement is not there. So when I see quality being treated as just like a tick mark, right, on the checkbox,

03:47
I see a lot more compliance risks and issues happening within an organization and then low morale, which equals high turnover. Nicole, is that what you’re seeing in your space and from your experience? Definitely from my experience, it’s really educating organizations on what quality is. What is the function of quality? Not just, okay, we are here to, or we were previously viewed as rubber stamping, just approving, writing SOPs.

04:15
he’s implementing training programs so much bigger than all of that. Oh yeah. And then I think that that’ll also look at stages of organizations, that a lot of organizations take the wait and see approach. They wait until they’ve reached an internal milestone, such as a submission of an IND, or maybe they are moving to a later stage in their organization clinically. We need to get quality on board and shove a lot of different, I would say immature processes that don’t have anything, uh

04:45
truly built and bringing those quality individuals in and expecting them to just kind of go along with it. It just doesn’t work. And it goes back to implementing the idea of quality at the start of an organization, understanding what quality is and obtaining just a more, a broader sponsorship, if you will, so that everybody is aligned. Then as you’re building these teams and you’re setting these expectations in place,

05:15
There’s more of a buy-in. And when you have a buy-in and collaboration, you’re going to have higher morale. Yes, I’m with you there. The collaboration piece is so key. And we missed that a lot, I think, from the quality side, being built into the leadership team. uh So yeah, I’m with you there, Nicole. Absolutely. Yeah, and as we talk through this and we understand this is always going to evolve and it’s going to change from organization to organization.

05:43
Really, what kind of strategic contributions are lost though when QA is excluded from early stage planning? What can we do to bring in innovative discussions? mean, Christy, I think I could take this one. It goes back to when quality is brought in. It’s when the teams are implemented and also when you have a quality team, when you’re pulling in your quality individuals. I personally feel that you will lose so much strategically if they’re not

06:13
or if their quality team is not involved in the timeline planning. And more importantly, at a contract level, if you’re looking to engage in partnerships or you’re looking to engage with bringing on CMOs, whatever it may be, whether you’re overseeing GCP quality or GMP quality, you’ve got to get in at that contract level to see what that business expectation is. What is the expectation? Are we looking to just do a real quick and then move on? Or are we looking to scale up with this organization?

06:43
And you really want to let your quality team be a part of that so that they can set their level of expectations externally as to what we want to see. And that will help with timelines, that will help with building relationships, trusting, accountability, all of that. Yeah, think bringing the quality team early on, right, it kind of follows a little bit with quality by design principles, right? And quality folks, our job is

07:11
right first time as much as possible. you bring us in early, you bring the team in, you bring the contribution in early on, you’re going to get that foresight, right? Bringing in quality early to make quality decisions to be able to put some proactive measures in place, right? You know, so that’s how you get to the faster timeline, right? And the less compliance risks and more efficiencies built into the process because quality looks at things a little differently, I think, than most.

07:39
other areas of the organization. I kind of think of quality and I say this everywhere that I go. Qualities like the customer service representative of a company, we go across the company or should in theory, right? uh We service almost every department. So I think it’s really important that we bring in our teams early on and everything to Nicole’s point, those are key things that companies should be doing, whether they’re smaller or larger.

08:07
Yeah, and it’s great that we’re bringing quality in sooner these days, but also we’re making our own shift, right? So traditionally quality has always been kind of mainly seen as that gatekeeper, that final check at the end of a process that it was done, right? And now over the years we’re seeing this shift into being a trusted partner and being that customer service representative working side by side with all the different departments, operations, R &D and our compliance teams. And now today,

08:36
in leading organizations, quality has really been stepping into the role of the strategic architect for building these processes along with our other departments, not just ensuring compliance, but shaping processes, influencing our culture, driving business success. So the journey has really been a shift from more reactive control and we’re crossing that realm into proactive leadership.

09:03
uh In my opinion, this evolution really highlights the importance of timing. So Christy, in your experience, uh as we reshape quality’s role, what small but high impact changes would you recommend happen today to start shifting from reactive to strategic? Okay, so some small impact changes I think would be start changing. So this is a big one.

09:32
Big one for me and a big one. hear another company. Sorry, it gets me a little excited because it drives me crazy. ah Change how we do meetings, right? That’s a small impact change, but I think at the end it’s going to bring in big efficiencies ah instead of just coming in. You know, I feel like a lot of times we’re coming in and we’re just reporting problems. We’re problem reporting to upper management or to whoever or providing oversight to our vendors. And here’s all the risks and the issues that we just kind of tick through them. But instead.

10:00
of problem reporting, why don’t we come in with solutions and ideas and do brainstorming sessions, solution finding workshops, things like that, things that are actually gonna get you somewhere. I think we’re too busy focusing on all of the reporting and the lagging indicators and the trending and all of that, that doesn’t actually bring us the proactive shift you’re looking for, what you’re mentioning, Danielle. I think just changing how we’re doing our meetings to make them more task oriented, like outcome oriented. And then,

10:30
making time to find leading indicators and looking at those. mean, lagging is important to a point, but let’s analyze the leading things first, you know, and that’s again a small impact change. And one that I love is rewarding proactive behaviors to reinforce the quality culture. I don’t know if we do that enough. And Nicole, I’d like to hear kind of your stance on that ah when it comes to rewarding proactive behaviors.

10:57
I love that I love that and I I definitely want to circle back to to what you were just talking about how we do meetings and I think it even goes back to how we do management reviews where you have an executive presence all present in a room. I mean, personally, I’ve seen it with very minimal executive presence to to everybody wants to come to the QMR and because they want to see because you’re doing it differently. It’s not producing just showing metrics and showing how many deviations you have or nonconformances. It’s.

11:25
other things and areas that you’ve already identified. I’m very proud of my quality unit because they identify problems and come up with solutions so that when I have to go speak to executive management, I’m already, we’re already talking solution-based instead of just problem-based. And I think that’s what we’ve got to do is when we’re producing and when we’re communicating to not only senior leadership, but other functional areas in an organization, we really have to show how it touches them and not just.

11:53
Okay, these are the deviations. This is what we’re presenting today. It’s other things. It’s training. Is there something wrong with the training program? We have maybe some areas of concern and we’ve identified that you are doing this. Maybe build a process around that. We’ve used MPG, obviously, for fit for scale processes and procedures that we put into place in our organization. And that works, again, scalability, pulling people in and helping them. um

12:20
I do believe in that positive reinforcement and I think quality is a little bit later to the game on that front. You see that more maybe on the commercial space that people, there’s metrics associated with performance, Or performance, I should say performance-based metrics. uh We haven’t really shown that. We always show the negative. How many deviations do we have? Do we ever really show the positive side of it? And so I think that that is definitely a shift.

12:47
and how we get to think as quality leaders and how we get to put a process around that. What does that look like? Is that something now that when we present, do we include that as part of our metrics? I think we’ve just got to look more into that.

13:04
Right. Yeah. And as we’re going through this journey, too, it’s I think what we also need to understand, and maybe you can lend your thoughts on this, about how we build credibility internally so that QA is then invited into the conversations earlier about not only quality problems and things we need to fix on our end, but more about the operations strategy and innovation of the organization as a whole.

13:31
not just bringing us in on audits and issues. What are your thoughts on that? That goes back to changing the mindset of what quality is. And even in this day and age, you have individuals come up and say, oh, you guys might not be that busy. uh SOPs are written or audits are done. And that’s not it. We touch every area of the organization. And we have the ability to change every aspect of the organization.

14:01
in setting what that expectation is. So building credibility is not waiting until functional areas build processes that we know won’t work and they just come to us and all of a sudden it’s non-conformance and deviation one after the other or an issue in trying to defend that in some sort of an inspection. Get involved and get in there. And I always say, never make an assumption, right?

14:26
I say that to the cross-functional teams, don’t make an assumption that this is something that quality doesn’t need to see. Sometimes it’s just being present and ensuring that you have a quality representative at every functional meeting. And you can politely say, okay, this is maybe it’s a non-GXP issue and thank you for the awareness. This could potentially come into our arena at some point, but you have awareness so that if something else pops up in another functional area, you can go back. I think it’s really collaboration.

14:55
and ensuring that you are positioning yourself to demonstrate what quality is, the different players in the organization. It’s certainly not just audits and issues and writing SOPs and training. And I think that we get to do a better job at educating internally what our departments are. I’ve had, you have many people maybe say, well, I don’t understand why quality would need to look at a contract. Well, there is quality language in a contract.

15:25
And if you don’t position or if you don’t put yourself your language, if you don’t use strong language in those contracts, well, how are you supposed to develop a quality technical agreement? And how are you supposed to position yourself with a CMO or an external body into what that expectation is and on what you need? If you’ve already if you have some wishy washy contract upfront, you’ve got to just get involved, get in there. Yeah. And I feel like we’ve we’ve talked about this so far.

15:52
throughout the entire, all the questions that Danielle that you’re asking us, Nicole and I bring up collaboration quite a bit. I keep hearing the word. So it’s gonna be probably a running theme when it comes to this topic. Credibility comes from consistency and contribution and showing up, Like you said, getting invited to those meetings, showing up prepared and ready to collaborate, right? That’s how we’ll build credibility. But also again, going back to the…

16:18
The why, right, Nicole? said like sharing the bigger picture. Why is quality here? ah How do we support patient safety, product success? How do we do those things, right? It’s telling that story. ah everything you said resonates with me from when I was back in industry to even now as a consultant going from company to company. It’s even part of my role still to get quality in there early, to help build that credibility and to build it from an external side as well as an internal side.

16:47
and to help our clients do that themselves. I mean, again, consistency, contribution, collaboration, those are like the three C’s when it comes to building that credibility. Yeah, and it’s really important too to, as we’ve been saying, to bring quality into the picture much sooner than it has been. And that’s why we’re starting to see this shift as being that strategic alignment, that architect, that partner. And ladies, you have led teams of different sizes, right?

17:16
Whether you’re leading a team of two or a team of 20, it’s really about making meaningful progress and kind of moving that needle without waiting for those quote unquote perfect uh conditions to bring quality in. um So we kind of want to talk a little bit about what can we do at a practical level or what can members of quality teams do uh to kind of help with this shift or talk about this shift? uh Kristi, as.

17:44
know, a seasoned leader uh in quality for so many years. What common pitfalls have you experienced when trying to build new QA capabilities on your teams? So I see this not just in building my own teams, but working with our clients trying to build new quality capabilities or new quality orgs is that sometimes they bite off more than they can chew too much too fast, right? And.

18:11
change management doesn’t happen quite like that and they lose the change management aspects of the project or what they’re trying to do. um And I think that you need to look at more of a phased approach to building a team or to building new capabilities or like, let’s say implementing a new QMS across an organization or what have you. I think a lot of times we struggle saying no as quality professionals. So we say yes to everything and bite off a little bit more than we can chew. And we don’t really look at having.

18:40
either a risk-based approach to doing things, new capabilities, new team members, or a phased approach into, we need these people up until this time. Then when we hit this timeline on our drug product life cycle, then we’ll get these people in. I don’t know if we’re really looking at it that way from what I’m seeing. Nicole, what about you? What are your thoughts on the pitfalls you see when building new teams or new capabilities? I mean, I always look at scalability and again, positioning yourself earlier in to understand what the business need.

19:09
What is the need for the business? Is this a business that wants to be an early phase company? Is this a business that wants to go to commercialization and really understand because you’re embedding yourself in other functional areas and being a part of the decision making as a true collaborator and building its team accordingly. completely agree with you, Christy. There are a couple of pitfalls. Sometimes you see organizations that will hide behind

19:39
budget constraints, if you will. you see that across the board, budget constraints in quality is not being an essential function. Let’s outsource it 100 % outsource. And then you find yourself while they’ve met their internal milestones. And now we need a quality unit. Let’s just hire five people who are now forced with whatever processes were put in place with an external view and they don’t work. A lot of times they just don’t work. Or you have

20:05
the building of a quality unit without having the right expertise there. People who maybe, you can have people from large pharma or small pharma, it doesn’t matter, but if you’re looking to implement and start a team at a smaller to mid-size organization, you’ve got to bring flexible quality individuals in, people who understand a lot about CMC, people who understand a lot about clinical operations, and build accordingly. And I think that is definitely a pitfall.

20:34
definitely and not taking the right approach to how you’re building your team. And also organizations just looking externally to providing those quality resources and signing off and then not it’s not truly representative of the processes that you’ve built. I think that there’s definitely opportunity for organizations to not go and take a scaled approach and hire 50 quality individuals, but really open their eyes and look and see what are the processes that we have? Are they compliant? If they are,

21:03
That’s what you build your procedures off of. Don’t try to reverse it. Don’t try to build procedures and then make everybody comply to something that just isn’t scalable for your organization. OK, and I like the point about having the right people in the right seats, you know, making sure that you have the right people for the job so that you also can stay compliant, build your team, but still scale. ah Sometimes when you don’t have the right people in the right seats, yeah, that can be troublesome.

21:32
There’s no way you can multitask if you’re in a smaller company and you’re doing multiple things. If you know the right people in the right spots, that’s really important. So knowing your people. Yeah, that’s important. I agree with you. It’s knowing who can do the job, who’s better suited for a certain position or role. I cross-training will always be an important function. But without the right people in the right areas, you’re bound to have some failures.

22:01
uh And as we kind of shift, as teams are shifting and growing and evolving in these new times, uh I know sometimes as we grow as people and as leaders, things can get kind of stalled if we’re not getting the momentum or the traction that we need. uh So how can we measure success early on and kind of keep that momentum and prove

22:24
that the impact of the QA evolution is real and it’s needed. Want me to take that one, Nicole? Want me to give it a shot? Give that one a shot. So momentum. me, give us a minute to think through that one a little bit. think so momentum is, it can be tough, right? It depends on, do you have enough resources? It depends on a lot of things, right? How to maintain momentum. But I think, you know, tracking metrics to tell a story can help and prove, at least prove our impact, right?

22:54
and keep momentum going with proving the impact of like that quality can make. Cause you said keep momentum and prove impact of the QA evolution, right? So continue to tell our story with metrics, right? Show a reduction in deviations and CAPAs, show fewer errors across the company because you’ve made better processes or you’ve worked with groups to streamline processes. Do a voice to the customer, right? That’s always a big one. That helps build engagement and involvement while still showing and proving

23:24
the impact that quality has. having, think early wins do matter. So I think those have to be visible from a quality perspective, even if they’re early on or they’re small, I think they should still be celebrated to keep the momentum going and to keep people engaged and to keep everybody moving forward um with changing the culture of why we have QA on our side and why QA should be a trusted business partner. So I guess showing why we matter, right?

23:54
um So that’s a little bit of kind of where my mind is going. Yeah, I definitely I agree 100 % with what you said. And I also think it’s executive sponsorship when you have support from the top and of full understanding and commitment to quality and what that full what quality is trying to drive and accomplish within an organization. By default, you already have a QA evolution there and you already are vetting.

24:23
quality into the business culture. there’s an awareness of the quality unit. And they know more than three names within your department and you’re present and visible and available. I think that’s definitely a successful aspect. Yep. Yeah, I think the whole visibility thing is really important to keep momentum going and to show QA impact. uh

24:50
Yeah, that’s a good point Nicole. I didn’t really think about the stakeholder piece, but and having the sponsorship, you know commitment that commitment from the top is going to be key for success around just building quality culture in general, not just the impact of QA, but really embedding that in the whole organization. So that was a good point. This has been a great uh conversation today and looking at how the future of QA is becoming that strategic partner rather than just reacting to issues.

25:20
uh Making this shift requires both, you need to have intentional changes in both your role and your behavior. But these changes across the board in any organization are absolutely achievable. uh All organizations have the potential to lead this transformation and build a quality function that really drives uh real business value. So uh ladies, I want to take this time to thank you so much for joining me today on this chat.

25:50
ah Nicole and Christy, thank you so much for your time. Do you have any words of wisdom you’d like to leave our audience today?

26:02
Any from would see. Let me think about that one. Well, yeah, my my biggest one that I would like to leave everybody with quality may not be everyone’s role, but it is everyone’s responsibility. That’s my key takeaway there. ah I think that’s going to be my key takeaway everywhere that I go, because it’s ties into the quality culture piece. It ties into, you know, having everybody understand a little bit about everyone’s role.

26:30
It does have a quality aspect to it, right? So that’s my little takeaway for the podcast. Thanks, Danielle. I appreciate that. Thank you.

26:40
Okay, again, ladies, thank you so much uh for joining me again here at Network Partners Group. We understand these challenges deeply. We’ve helped clients successfully transition from that gatekeeping mode to that future-focused QA leadership. um If you’re ready to lead the charge in your organization, please reach out to us on LinkedIn or at onenpg.com and let’s get your conversation started. We’re here to partner with you on your journey. Thanks for joining us today.

27:10
Have a wonderful day. Thank you. Thank you.