Donna Matuizek
About Donna Matuizek
Donna Matuizek serves as the Senior Director of Quality and Regulatory at Magnolia Medical Technologies and has over 30 years of experience in the biopharmaceutical and medical device industries, including significant roles at Immusoft Corporation and Just Biotherapeutics.
Work at Magnolia Medical Technologies
Donna Matuizek serves as the Senior Director of Quality and Regulatory at Magnolia Medical Technologies. She has held this position since 2022, contributing her extensive experience in quality assurance and regulatory compliance. In her role, she focuses on ensuring that the company's products meet the necessary regulatory standards and quality benchmarks. Her responsibilities include managing supplier relationships and conducting audits to maintain compliance with industry regulations.
Previous Experience in Quality and Regulatory Roles
Prior to her current role, Donna Matuizek worked at Just Biotherapeutics as the Senior Director of Quality from 2016 to 2022. She also held the position of Vice President of Quality at the same company from 2018 to 2022. Her earlier career includes significant roles such as Director of QA/RA at Blood Cell Storage, Inc. from 2010 to 2015, and Sr. Manager of Contract Manufacturing at Dendreon from 2000 to 2007. These positions have equipped her with a strong foundation in quality management and regulatory affairs.
Education and Expertise
Donna Matuizek earned her Bachelor of Science degree in Business Management from the University of Phoenix, where she studied from 2001 to 2003. Her educational background complements her extensive professional experience in quality assurance and regulatory compliance. She possesses expertise in aseptic process validation, regulatory affairs, and compliance with ISO standards, which are critical in the biopharmaceutical industry.
Skills in Quality Assurance and Regulatory Compliance
Donna Matuizek demonstrates a strong skill set in problem-solving and root cause analysis, particularly in the context of Corrective and Preventive Actions (CAPA) management. She has a proven ability to establish effective relationships with contract manufacturing organizations and stakeholders. Her knowledge of Good Manufacturing Practices (GxPs), ICH Guidelines, and various regulatory frameworks, including 21 CFR parts 58, 210, 211, 610, 803, 806, and 820, supports her role in maintaining compliance and quality standards.
Long-term Advisory Role at Immusoft Corporation
In addition to her current position, Donna Matuizek has served as an Advisor at Immusoft Corporation since 2009. This long-term advisory role highlights her commitment to the field and her ability to provide valuable insights based on her extensive experience in quality and regulatory matters. Her involvement with Immusoft complements her work at Magnolia Medical Technologies and reflects her dedication to advancing quality assurance practices in the industry.