Donna Matuizek

I’m Donna Matuizek, a Quality and Regulatory Affairs expert based in Seattle, WA, with over 30 years of experience in biotech, pharmaceuticals, and medical devices. My career began in the 1980s, helping develop the first FDA-cleared HIV blood screening test. Since then, I’ve worked at companies like Immunex, Dendreon, AGC Biologics, and Magnolia Medical, contributing to groundbreaking therapies and innovative diagnostic tools. I’ve led FDA inspections, built quality systems from the ground up, and guided teams through complex compliance challenges. I’m passionate about creating safe, effective healthcare solutions and building strong, collaborative teams. Outside of work, I love cooking, gardening, and being part of supper and book clubs. I’ve completed multiple half-marathons and one full marathon at Disney World. I also give back to my community by preparing meals for a local women’s shelter. I believe in learning, listening, and staying curious. I’m currently open to new opportunities where I can keep making a meaningful impact.