Donna Matuizek
Senior Director, Quality and Regulatory
Seattle, Washington, United States
About Donna Matuizek
Donna Matuizek is a biotechnology and medical device professional with over 35 years of experience in quality assurance, regulatory affairs, and manufacturing operations. She has worked in biologics, cell therapies, in vitro diagnostics, and medical devices. Her expertise includes building and managing quality systems, preparing regulatory submissions, and leading successful FDA and international inspections.
Matuizek began her career at Genetic Systems, where she helped develop the first FDA-approved HIV-1 blood screening test. At Immunex, she established the Quality Control lab and supported the approval of Leukine, a GM-CSF biologic drug. She later worked at CTI BioPharma as a research scientist in cell biology.
At Dendreon, she built the Quality Control function for Provenge, the first FDA-approved cell therapy for prostate cancer. She also managed external manufacturing at clinical sites. As a consultant and later as Director at Blood Cell Storage Inc., she led regulatory and quality work for medical devices, achieving ISO and CE certifications.
At AGC Biologics, she directed QC and regulatory teams, supporting FDA pre-approval inspections. She then joined Just Biotherapeutics (later Just-Evotec Biologics), where she served as Vice President of Quality. There, she built QA/QC teams and qualified a new manufacturing facility for clinical and commercial use.
Most recently, she worked at Magnolia Medical Technologies as Senior Director of Quality and Regulatory. She oversaw product transfers, validated electronic systems, and led the team through FDA clearance of a Class II diagnostic device.
She holds a BS in Business Management and an AAS in Chemical Technology.
Areas of Focus
Career Background
Genetic Systems
Education
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Press
Donna Matuizek Featured in Exclusive Interview Highlighting Her Lifelong Commitment to Quality and Innovation
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What does Donna Matuizek do?
Donna Matuizek is Senior Director, Quality and Regulatory at Magnolia Medical Technologies. She is a biotechnology and medical device professional with over 35 years of experience in quality assurance, regulatory affairs, and manufacturing operations.
What is Donna Matuizek known for?
She is known for building and managing quality systems, preparing regulatory submissions, and leading successful FDA and international inspections across biologics, cell therapies, in vitro diagnostics, and medical devices. Her career includes work on the first FDA-approved HIV-1 blood screening test and Provenge, the first FDA-approved cell therapy for prostate cancer.
Where is Donna Matuizek based?
Donna Matuizek is based in Seattle, Washington, United States.
Where did Donna Matuizek study?
She earned a Bachelor of Science in Business Management from the University of Phoenix and an Associate of Applied Science in Chemical Technology from Seattle Central Community College. She also attended the University of Washington for general studies in 1976.
Who does Donna Matuizek work for?
Donna Matuizek works for Magnolia Medical Technologies, where she serves as Senior Director, Quality and Regulatory.
Last updated July 23, 2026