By Donna Matuizek
The Misconception About Quality
Let’s start with the elephant in the room: in many biotech organizations, the Quality department is seen as the “no” department. “No, you can’t do that.” “No, that’s not compliant.” “No, not until we finish validation.”
I’ve lived this. I’ve seen the eye rolls when QA walks into a meeting or the sighs when a regulatory question puts the brakes on a fast-moving idea. And yet, I’ve also seen firsthand how the most innovative companies are the ones that understand that true innovation doesn’t happen in spite of compliance—it thrives because of it.
Throughout my career—from early HIV diagnostic test development to cell therapies and medical devices—I’ve come to believe that our role as quality leaders is not to be the gatekeepers of “no,” but the enablers of smart, sustainable innovation. That starts with shifting the mindset—from compliance as a constraint to quality as a confidence-builder.
Building the Foundation for Bold Ideas
Great ideas in biotech don’t start in isolation—they start in cross-functional conversations. When I’ve seen innovation truly take off, it’s because scientists, engineers, quality professionals, and regulatory experts are sitting at the same table from day one.
That means building a culture where QA and RA are not brought in at the end to clean up the mess or “check the boxes,” but are integrated from the start. When quality professionals are part of early development conversations, we can help design processes that are not only compliant but also scalable, efficient, and ready for what’s next.
For example, when I led Quality at Just Biotherapeutics, we built a greenfield manufacturing facility in 18 months—during COVID. That kind of timeline would’ve been impossible without embedding quality into every phase, from construction to validation. We didn’t cut corners. We built confidence.
Empowering Teams with “Why”
One of the most powerful tools I’ve used to inspire innovation is education—not just about what needs to be done, but why it matters. People don’t connect to policies. They connect to purpose.
When teams understand the why behind a regulatory requirement or a validation protocol, they’re far more likely to engage, contribute ideas, and innovate within those boundaries. I’ve spent many hours walking teams through the rationale behind GMP standards, explaining the risk-based thinking behind our change controls, or showing how one missed deviation could impact a patient’s experience.
The result? Teams that don’t just follow the rules but take ownership of them. That’s when compliance becomes confidence.
Saying “Yes, If” Instead of “No”
I’ve found that language matters—a lot. Instead of defaulting to “no,” I’ve trained myself and my teams to say “yes, if…”
“Yes, if we can validate this step.”
“Yes, if we update the risk assessment.”
“Yes, if we bring RA into the loop now.”
This approach not only preserves quality standards but fosters collaboration. It keeps the door open to progress and positions QA as a partner in problem-solving. We’re not there to slow down science—we’re there to help it succeed without creating risk down the road.
This shift is especially important in high-stakes fields such as cell and gene therapy, where development is outpacing regulations. In those cases, we must lead with critical thinking, apply scientific judgment, and navigate uncertainty with both rigor and creativity.
Modeling Calm in the Chaos
Let’s be honest—this work can be stressful—inspections, deadlines, changing guidance, and the ever-present pressure to get products to patients. But one of the most important leadership lessons I’ve learned is this: if you stay calm, your team will follow.
Confidence is contagious. When I walk into a meeting or an audit with clarity and composure, it creates a sense of stability. My team knows I have their back. And more importantly, they know I trust them. That trust creates space for innovation because people feel safe speaking up, sharing new ideas, and raising concerns early.
That kind of psychological safety is the secret sauce behind high-performing quality teams. It doesn’t come from micromanagement. It comes from trust, mentorship, and leading by example.
Measuring Success Beyond Checklists
One of the most meaningful metrics I’ve tracked over the years isn’t found on a dashboard—it’s staff retention. I’m proud to say I’ve maintained a 95%+ retention rate across many years of leading quality teams. Why? Because people stay where they feel heard, challenged, and valued.
Yes, we pass audits. Yes, we get products approved. But even more rewarding is seeing a junior QA associate grow into a confident manager, or watching a regulatory specialist take the lead on a successful submission. That’s how I measure success.
Quality as a Launchpad
To all my fellow leaders in biotech and life sciences: let’s change the narrative around quality. Let’s stop seeing it as a barrier and start using it as a launchpad for smarter systems, better products, and more empowered people.
Compliance and innovation are not opposites. The best innovation happens when you’re grounded in a system you trust. Quality is not about control—it’s about confidence.
And when your team feels confident, they won’t just follow the path—they’ll help build the future.