From Compliance to Confidence: How Quality Leaders Can Inspire Innovation Without Compromising Standards
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 […]
Wine Tasting and Team Building: Creative Ways to Foster Culture in Quality-Driven Organizations By Donna Matuizek
Why Culture Matters in Quality-Driven Workplaces When people think of careers in biotech, they often picture labs, SOPs, audits, and regulatory checklists—and they’re not wrong. But behind every approval and inspection-ready system is a team of people, and how those people feel about their work—and each other—can make or break performance. In Quality Assurance and […]
Audits, Approvals, and Aperitifs: Managing Stress and Success in Life Sciences Careers By Donna Matuizek
The Balancing Act of Biotech Working in biotech and life sciences is rewarding—but let’s be honest, it’s also incredibly demanding. Between preparing for FDA inspections, meeting regulatory deadlines, managing teams, and keeping up with evolving guidance and technologies, the pressure can be intense. Over the years, I’ve learned that while the work can be high-stakes, […]
Resilient by Design: How Female Leaders in Biotech Are Shaping the Future of Quality and Compliance By Donna Matuizek
A Seat at the Table When I started my career in the biotech and life sciences industry, there weren’t many women in leadership—especially not in Quality Assurance, Regulatory Affairs, or technical operations. Most of the time, I was the only woman in the room during inspections, audits, or executive planning sessions. But over the decades, […]
Quality Culture in the Life Sciences: Why Staff Retention Begins with Empowerment By Donna Matuizek
Introduction: Why Quality Culture Matters If there’s one thing I’ve learned over the years in Quality and Regulatory Affairs, it’s that a successful company isn’t just built on strong systems but on strong people. In the life sciences industry, where patient safety and product integrity are non-negotiable, the culture of your team matters just as […]
From Bench to Bedside: Navigating the Regulatory Pathway for Cell and Gene Therapies By Donna Matuizek
Where Science Meets Regulation When I first stepped into the world of cell therapy back in the early 2000s, I knew I was entering a space where science was rapidly evolving. I didn’t fully realize just how complex the regulatory journey would be for these types of therapies. Unlike traditional pharmaceuticals, cell and gene therapies […]