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 […]