BIO

Stefan Zietze

Executive Director, Head QP & Quality Mgt -Safety & Logistics

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As a Registered Pharmacist Stefan is passionate about Drug Products and their optimal application at patients in need. Predominantly, in the next 10 years biopharma innovation will be driven by the product classes coming out of the exciting field of Cell and Gene Therapy (CAGT). Stefan is a critical thinker and identifies areas of risk in global supply projects highly efficiently with a clear solution-orientation for sponsors and never loosing focus of protecting the receiving patients.

Work Experience

Stefan has started his career in biopharmaceutical pre-clinical product development and manufacturing in the Quality Control unit in a highly innovative CDMO-environment, understanding very soon that only excellent science and reliable technological solutions can keep you successful in this highly competitive market. After 10 years he has moved to the global commercial production scale, extending his knowledge to classical drug product classes, and learning about areas like Indirect Quality Control and Quality System Management. In 2012 he also became Qualified Person supporting a production site managing 150 different SKUs for more than 180 different markets. During this time Stefan could master his Six Sigma Green Belt and adopt methodologies of the ‘Agile Transformation’ tool box. In 2018, Stefan then moved into the exciting field of Clinical Research and Clinical Trial Supplies and Laboratory Sample Logistics applying his knowledge to streamline the Logistics Quality Management team and to help grow the Parexel CTS&L-business. In 2023, his areas of responsibility were extended to the Parexel Safety business unit. Within CAGT, his current interests and commitments lie in finding logistical solutions for CAGT IMPs that are compliant with the multiple regional manufacturing, import/export and distribution regulations and that allow a seamless product release to deliver the products on-time and in-full to the patients in need.