Why Quality Leaders Burn Out (and How to Prevent It)

Let’s Talk Quality – Quality Unplugged, Episode 2

A Candid Conversation About Strengthening Quality Leadership

Leading quality isn’t just about SOPs, audits, and compliance checklists. It’s about carrying the weight of product safety, patient outcomes, and regulatory risk, often while managing resource constraints and shifting expectations.

In this episode of Let’s Talk Quality – Quality Unplugged, host Danielle Metzger, Associate Director of Quality at NPG, sits down with Christy Mazzarisi, Principal Consultant and Quality Leader at NPG, and Marcus Grell, Senior Vice President and Head of Quality at Autolus, to unpack a topic that rarely gets discussed openly: burnout among quality leaders.

Together, they explore:

• The hidden causes of burnout in quality assurance roles
• How insufficient training and unclear role boundaries contribute to stress
• The leadership behaviors that prevent burnout and empower teams
• Why embedding a strong quality culture across all departments matters
• How resource models and external partnerships can reduce pressure
• Strategies for communicating value and securing executive support

Watch the full episode 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: 

• Marcus Gruell, Senior Vice President and Head of Quality, Autolus – Brings experience in establishing robust quality foundations, developing PQC infrastructure, and leading digital transformations of GXP systems essential for commercial CAR-T cell product operations.
• 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

• Burnout is often systemic, not personal. Quality professionals tend to blame themselves for feeling overwhelmed, but the root cause is usually unclear expectations, poor training, or overloaded systems.
• Leadership behavior sets the tone. Empowerment and psychological safety matter. Leaders who trust their teams and communicate clearly reduce stress and increase engagement.
• Quality shouldn’t be the “safety net” for unclear ownership. When accountability gaps default to QA, teams become overextended. Empowerment and role clarity help distribute ownership more evenly.
• Resource models protect both quality and people. A proactive quality resource model (QRM) helps leaders scale capacity and prevent burnout before it begins.
• Culture and collaboration matter when adding external support. Technical skills are critical, but cultural fit and knowledge transfer ensure lasting impact when bringing in consultants or contractors.
• Speak leadership’s language to gain support. Quality leaders who frame their needs in terms of risk, revenue, and reputation can more effectively secure resources and influence decisions.

Ready to Strengthen Your Quality Organization?

Whether you need expert consulting, short-term staffing support, or a proactive quality strategy, NPG’s Quality & Compliance team helps life sciences companies reduce burnout, close compliance gaps, and elevate quality as a strategic partner. Contact NPG to start a conversation about your organization’s needs.

Related Resources

If your organization is facing quality burnout, backlogs, or resource challenges, NPG can help you strengthen your team and build a proactive quality culture.

Explore these resources:

• NPG Quality & Compliance Services
• Remediation Support
• Quality Whitepapers and Case Studies

Episode Transcript

00:00
Hello everyone and welcome to NPG’s 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 here at Network Partners Group. In our episode today, we’re going to be discussing why quality leaders burn out. So let’s be honest, leading quality isn’t just about SOPs, audits, compliance checklists,

00:29
It’s about carrying the weight of product safety, patient outcomes, and regulatory risk, all while navigating internal pressures, resource constraints, and ever-changing expectations. It’s no surprise that even the most senior quality leaders can feel overwhelmed or worse, burnt out. Today, we’re diving into why this happens, and more importantly, what can we do to create success? It’s not just about compliance survival.

00:58
To help us unpack this, we’re joined by NPG’s principal consultant and quality leader, Christy Mazzarisi, and our guest speaker, Markus Gruell, senior vice president, head of quality from Autolis, a company that is building advancements and therapies for cancer and autoimmune diseases. Mark is a seasoned quality leader that has been instrumental in establishing robust quality foundations, spearheading the development of the PQC infrastructure,

01:26
and has led digital transformations of GXP systems essential for commercial car T cell product operations. Markus and Christy, thank you so much for being with us today. Thank you for having me. So let’s start by calling out what often goes unsaid in quality roles. Burnout doesn’t always look like someone waving a white flag, right? It can show up in subtle chronic ways, having missed deadlines, having constant reactivity to problems,

01:56
or leaders just quietly carrying on too much for too long, right? So let’s kick this off and unpack what burnout really looks like in QA and why it’s more common and more damaging than most teams really realize. So Markus, in your experience, what role does insufficient training and unclear role boundaries play in causing burnout?

02:22
In my experience and in my view, insufficient training can create uncertainty within the teams, within a person who is not feeling adequate to perform their tasks effectively. That can create a sense of lack of accomplishment, lack of confidence.

02:45
and it can lead to mental exhaustion as well as they constantly trying to figure out how to perform the tasks in the best way possible without being trained properly.

02:57
On the other hand, it’s also important to know that employees tend to blame themselves if they fail, although it’s the system. It’s never that we as leaders need to acknowledge and need to really emphasize the message that it’s not their shortcomings. It’s the system that fails them. It’s not them who fail. OK, that makes sense to me.

03:27
Thinking about a little bit, I kind of thought about confusion for end users, right? The people who are the ones who should be trained or need to be trained properly. If they’re not sufficiently trained, to me, I’ve seen a lot of teams either duplicate efforts because they don’t know where their job starts or ends, right? It’s not clear because they haven’t been properly trained. And like you said, they blame themselves. So the burnout is real. I think it’s stress-related, right? So not understanding.

03:56
where the lines are or where the box is for them and their roles and responsibilities, I guess a little bit.  That’s a lot of what I see, you know, and as a consultant and even on the other side, when I sat, you know, on the sponsor side, anytime there were not clear roles or proper training,  I saw a lot of people very stressed out over tasks that they’re doing, feeling they were doing someone else’s task. And then that just causes stress and negativity in the whole environment. So that’s some of what I’ve seen when, you know, in my experience.

04:27
And organizations have been very, very adamant now about making sure that we have lower stress-free environments, ah they have more engaging activities for people at all different levels. But how important is leadership involvement in preventing burnout? And what behaviors from leadership make the biggest difference? I love this question. Go ahead, Markus.

04:54
I’m trying my best to answer it. there’s always the role of a leader is important that in that we have to resource tasks appropriately. resource allocation is obviously paramount to creating a stress free environment as much as possible. It’s also that we set our expectations and we communicate them clearly to

05:24
to the teams. going back to the job roles and the boundaries, people need to be clear on what their tasks are, what is expected from them. So it’s important that, yeah, again, that we clearly communicate what the expectations are and obviously be there to support them, not micromanage them. If, at least in my experience, if employees are being micromanaged, they get even more stressed.

05:53
They don’t feel supported really by being micromanaged. They feel observed. They feel chased. It doesn’t create confidence in them. One of my mottoes is I let them basically run with the projects, with tasks, but I’m always there in the background to support them if and when they need. I offer help, but I’m not imposing help.

06:22
this is at least something that works well in my experience. Oh, that’s a good answer.  And from a leadership perspective also, and being somebody who wouldn’t like to be micromanaged, I can see that as being a cause of stress, right? Completely. You got to be empowering for your employees, right? And an empowered employee tends to increase morale, which tends to lead to less mistakes, right? And then

06:51
Hopefully less burnout. For me, leadership is everything when it comes to reducing stress on the team. And it’s all about not really the title, right? It’s not titles, but do you have people who are actually following? Can you lead by example? Can you be the lighthouse, right, for your employees? And that’s kind of what it sounds like you are, Markus, you know, not micromanaging, there for support,  you know, someone they can look to if something is hard, if they need the extra help, they know you’re there, but you also give them the safe space

07:21
to try things on their own and more of the psychological safety piece, right? Like, okay, Markus is letting me do this, but if I fail, he’ll help me clean up the pieces, right? That’s a big motto for me is I wanna give everyone the chance to succeed or fail, but I’ll be there to help you clean up if something goes wrong, you know,  with no judgment. We’ll fix it, we’ll figure it out and we’ll move forward together. So that’s a big piece from a leadership perspective that’s super important for me, whether as a leader or whether under someone’s leadership.

07:51
Yeah, I couldn’t agree more. Sorry, I’m to burn out. OK, no please. was going to say just burn out too. Could also be looking at like our quality culture, right? How what does our quality culture look like? And is that causing our burnout? Depending how how good the culture is or where the culture may be lacking. So in that essence, what culture changes need to happen within quality departments now to break the cycle of burnout and the reactive firefighting?

08:28
That’s a good question. I need to emphasize that it’s important that quality people, that quality culture gets embedded across the company.  More often than not, especially in companies that are not as mature as they should be or as they could be, whenever there’s a lack of  certainty of who is owning a task, who is owning a project, it goes to quality because

08:58
Quality is always like the safe haven, it’s the safety net of the company. We manage the risks, we manage compliance. So if there’s any doubt, who is accountable for this, let’s give it to quality. And that then leads to an overload of tasks, of workload, of stress. Again, it all goes back to empowerment and to job roles and to training. If people are empowered,

09:28
to say no, to push back when they are clear on their roles, clear on the expectations, and push it back to other functions that are more appropriate to own certain remits, it creates a more manageable environment for the quality teams, for the quality functions. Again, in my experience, there’s a lot of handholding required in younger companies, companies that are growing, are establishing the systems at the start. It’s always like quality that is leading the way, but as a company matures,

10:11
the accountabilities and the responsibilities need to be shared across equally across all functions equally. I kind of want to touch on two points that you brought up, because they resonate with me the most.  I’m a huge quality culture person. It’s one of the biggest things that I try to impact wherever I go.  So two things stuck out. One was  saying no, right? I don’t think quality people do that enough.

10:42
from, like you said, when something doesn’t have clear ownership, oh, quality, we’ll figure it out, right? Give it to them, they’ll do it, right? We are not the owners of everything. So I try to stress that a lot. We’re not the owners of all these different things that go on in an organization from an operational perspective. Like a lot of times, oh, quality, you can write all the investigations, right? That’s an example that I hear across the landscape from all of my quality friends. It’s like, oh, they’re always trying to make us do the investigations. It’s like, well,

11:09
We’re not really the investigation owners. may own the process and we can walk through it with you and we can teach you and mentor you, but we’re not the owner. So being able to push back and say no to certain activities is going to be key. Not just from an employee perspective, the people on the ground, but also leadership to say, we don’t own that. You know, this is where it typically sits in an organization and shielding the team from that stress and that burnout.

11:34
as a leader. So that kind of resonated with me a little bit. And then the embedding the culture piece with across the organization. So to me, I see quality trying to do their job a lot and different companies, but then overall leadership not taking it across all of the departments. So that’s the tough pieces. How do you get everyone to want to embed it from the top top, right? CEO commitment downward, right? How does, you know, how can we get that embedded

12:04
from the ground level, right? Quality may not be everyone’s job, but it’s everyone’s responsibility. That’s a little motto that I tend to use, but it works. It kind of it in perspective, right? How can we think quality first? Yeah. And then less burnout, right? I feel like if we can do that, there will be a lot less burnout, because we’ll always be building quality into every decision that we make throughout the day, you know? Exactly. back to your point about saying no, I think in quality,

12:33
It’s one of our things as quality personnel that we never kind of want to say no, because we know how important things are to get the job done. And we’re always willing to lend a hand, right? We’re the hand helping department that wants to help everybody along on their journey to make sure everything’s done compliantly. But at times we do have to say no. And then that is one of the biggest challenges that leaders face is how to balance that workload effectively so that no one is overwhelmed and that quality doesn’t suffer.

13:01
One of the ways that I’ve seen that happen is that organizations put into place a quality resource model, right? So the QRM kind of works by giving leaders a structured, a proactive way to scale our capacity to protect the team and wellbeing and ensure that quality doesn’t drop. Whether things are calm, whether they’re busy or the whole world is on fire at that time, right? We try to have something in place for that.

13:27
And this model shifts depending on company activity, kind of where we are in the product life cycle,  and for any unexpected issues.  It may be necessary though in those times of influx to bring in flexible resources and engage with external experts that truly can come in and support our team and not just add complexity. So Markus, from your perspective, what are the biggest risks?

13:54
of trying to manage quality with a static team structure during times of rapid growth or unexpected challenges.

14:03
In my view, in my experience, the biggest challenges are kind of a knowledge bottleneck. That’s number one. Number two is also the scalability, obviously, of a company, of an organization. So let me touch on the first one, the bottleneck piece. If you have like a static structure in teams and people are only skilled and trained in certain specific areas,

14:31
it tends to get to a point where many, many tasks get assigned to only a small number of people who are trained in specific tasks and that creates a bottleneck. If you have a matrix approach and you can cross train as many people as possible in your organization, you have a broader  spectrum in terms of skill sets across

15:01
several sub teams, which then leads to a more manageable environment in terms of, again, task completion, tasks, assignments,  overall support of each other.  In my organization, we are still in the process of training everybody cross-functionally as much as we can. Obviously, there’s a kind of a

15:29
trade-off as well. You need to have certain specialists in certain areas. Not every skill has to be trained cross-functionally. Not every person in a 50-people team needs to know every single, needs to have every single skill, but you need to focus on the critical skills and have them trained across the board. That’s vital to

15:58
use the bottleneck in the team. And the other one was around scalability. Obviously, if you want to expand the remit of your team, you need to have like a  flexible skill set across the team. So you can then move people around if needed. In times of crisis, get one or two people from that team to the other team to support them to manage their workload and so on.

16:28
And when you hire people and scale up, you need to look at their skill sets as well. But it’s always important that they are flexible. Their mindset is flexible. And they are willing to take on new skills and take on new tasks if needed. So these are my two points here. OK, yeah, static teams are not really built to scale. So having the flexibility or

16:53
I hate to use the term generalists, but folks who can jump in in various places because they’ve done many things is super helpful. I think static teams also tend to be very reactive instead of proactive. So you’re not really forward looking. Some of what I’ve noticed, and it’s not really, I would say if you’re in a fast paced environment and you have a static team, it’s gonna be really tough keeping up while still being able to make tough decisions.

17:22
So I think that’s also where a little stress may come into play with the team and being able to cross train, like you said, is gonna be key, right? Going back to quality culture, making sure everybody understands, let’s try and be proactive instead of reactive, right? Like, can we get the team to just change the way they think and then add in those players that can jump in from area to area when needed? And then how can we develop others to be more

17:50
flexible as well. So kind of looking at all those bits, right? Yeah. And in times, Christy, in those times where we do have shifts and we can’t solely rely on our team members, right? What criteria should organizations use when they need to start deciding on engaging external consultants or contractors to come in for quality support? So being on all sides of the fence in my career, I’ve been

18:20
Sitting in all you know all seats here when it comes to external resources versus sponsor versus vendor and CDMO right? I’ve kind of been in every one of those positions,  but when you’re thinking about bringing in an external resource, don’t just look at the technical skills, because I feel like a lot of times we’re looking for the best technical person possible to come and do. Job X, whatever it is right, but we forget that if we wanted to go well, they also need to be a good cultural fit.

18:49
And that’s the part that we miss a lot of times, especially if it’s a high profile item that you’re trying to get external support on. Cultural fit is gonna be key on top of anything else. If they can’t play well with the team, if they can’t collaborate, if they can’t have peer to peer support and with the team that they’re coming in for, it’s never gonna work no matter how smart they are, how technical they are. So really finding somebody or a company

19:18
that has the same values as your company or aligns in those ways, I think that’s also going to help the project go better. that’s the one piece that I see a lot of sponsors forgetting is, technical is important, but don’t forget about the cultural piece. Are they and their team a good fit for your team? So that’s just one of the pieces that I always try to stress even when I was on the sponsor side. Spot on, yeah. I was lucky so far. I have four or five contractors in my team

19:47
consultants slash contractors and they are a great fit for the culture. But I’ve seen it in other departments and other functions where again, contractors consultants had to leave after four or five weeks because it was clear they weren’t a good fit for the team. What I also try to stress to my team when we hire external ad hoc support to get the knowledge

20:17
transfer into the team as well. There should be like a kind of a mentor mentee pairing between the contractors, consultants and internal employees to get them also up skilled and learn from the consultants because they usually tend to have obviously more experience, technical expertise than employees. So I can only

20:46
recommend doing that to pair them up with internal team members. Yeah, that’s a great idea too because you know end users or the quality folks that are already in the department and then when they see external resources come in, right? They kind of can get a little jittery and be like, God, what is happening? They’re going to come over. They’re going to take over my role. But if you kind of like you said, pair them up into a mentorship type program.

21:14
that to me would be very valuable. shows that you can, one, learn from the expertise you’re bringing in-house that you’re lacking, but then that expertise gets to learn exactly how the department runs, the processes, and everything that’s necessary to then let them have that eye-opening experience to help make change.

21:35
Yeah, indeed. Right. And whether we are, you know, looking for external resources or organizations or hiring full time employees,  quality leaders can make compelling business cases. They have to make compelling business cases, right, to get that additional support. So let’s talk about some of the strategies for communicating value to leadership, kind of demonstrating what the return on investment is and shifting from that reactive, like I said again, reactive firefighting.

22:04
to have a proactive resource planning. So Christy, in your experience, what are the most common challenges that QA leaders face when they’re trying to secure additional resources or support from senior leadership? So a lot of times, and I’ve been in this exact position multiple occasions across my career, and I’ve learned every step of the way, right? Every time I didn’t get what I needed, I learned what I had to do better.  One of them is speaking their language, right? The common challenge is how can I speak

22:34
their language to get what I need from a project standpoint or resource, whatever it is, right? How can I get that budget right at the end of the day? And quality tends to get the least of it in most cases from what I hear, right? And from my own experience. But how can we show return on investment, right? How can we speak the language of the executive level to say, here’s what I need, here’s how it’s going to save money, time, build trust with the regulators.

23:02
make us more compliant, whatever it is, right, that they care about, right, which is typically risk, revenue, and reputation. Those three things, the three R’s, right? So if we think about that and we touch on each of those points, I think that will alleviate the language challenge  between a quality professional and then the executive leadership when trying to get resources or.

23:27
whether it’s FTEs, whether it’s project related, whatever it is, I think that’s one of the challenges is the language piece. And the other is probably around leadership not really walking the floor enough to really feel the pain of what’s actually going on. So there’s a perception gap there that sometimes has to be covered if leadership is very hands off. So those are the two challenges that I faced anyway, and that I see the most. Markus, what do you think you’ve seen in your career as you’ve kind of grown up in it?

23:55
There’s not much to add here to be honest here. You hit the nail on the head. It’s always about return of investment. It’s always about compliance risks. I personally, I don’t want to go into those conversations with the CEO or other executives always like wielding the compliance risk flag because they’re getting tired of it. Yeah, but our inspections always went well. So what’s your issue? Obviously, if there is a

24:24
major finding or critical finding then they listen. That’s for sure but that’s usually too late. I would like to preempt this. What is extremely helpful is when you can say in terms of brand value and reputation you can show them other examples from the industry that this was like a warning letter from the FDA. Look at the findings.

24:54
we are heading towards this if we don’t do X, Y, Z. So that helps as well. And basically what you said, Christy, is that you want to emphasize the need for the license to operate. You need to have the license to operate. And that should be one of the key metrics in the company. If that is at risk, we have gone way too far in the wrong direction. And we need to course correct this now to get this.

25:34
back on track. So the business case needs to be needs to be solid and on good grounds in terms of risks to the company and risks of revenue eventually. Yeah, I like bringing up the idea of, you know, because that was also something on my mind is, you know, bringing up trends from what’s going on out there in the regulatory environment that helped prove your case a little bit like, hey, here’s my whole list of look what’s going on. And this is part of the reason why right coming with the data, right? Coming with data.

26:04
Data points, yeah. It works best. Yeah, and I mean, we’re always going to have that burnout scenario, right? But it’s all about switching our mindset from reactive to proactive. So looking at your quality resource model, you know, more times than once a year, going over quarterly with your teams to ensure that you understand and navigate the path forward. What’s happening in your organization now?

26:32
versus what the organization is planning in the next year or two. All of that combined should help to alleviate the burnout that leaders are seeing, if resourcing is being planned appropriately. To wrap up, we’ve learned that burnout in QA is a widespread but preventable issue and that having the right resource structure is critical for managing workloads effectively and that seeking support shouldn’t wait until a crisis hits.

27:02
Markus and Christy, thank you so much for joining me today and sharing these invaluable insights that I’m sure resonate with our audience greatly. If you would like to learn more or discuss tailored solutions, our consultants here at the Network Partners Group understand these challenges deeply. We’re here to help build a resilient, high-performing, quality team ready for whatever comes next.

Please connect with us on LinkedIn or go to our homepage at onenpg.com and let’s get the conversation started. Thanks for tuning in and have a great day.

Explore More Episodes

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