Cell and Gene Therapy (CGT) Quality Program Owner | Cell and Gene Therapy (CGT) Quality Program Owner (m/f/d)
Bayer AG Pharmaceuticals
Job Summary
As the CGT Quality Program Owner at Bayer, you will be the primary architect and lead for the global Quality Management System (QMS) specifically tailored for Cell and Gene Therapy. This high-impact role involves designing and implementing core quality programs and standards across the entire Bayer network, spanning from early development to commercial phases. You will act as a critical bridge between manufacturing, supply chain, and regulatory affairs, ensuring all Advanced Therapy Medicinal Products (ATMPs) meet strict GxP and regulatory requirements. Day-to-day, you will provide strategic oversight, facilitate FDA inspection readiness, and lead a matrixed organization of subject matter experts. This position is particularly attractive due to its high level of accountability, the opportunity to shape the quality landscape for cutting-edge medical technologies, and a highly competitive compensation package including hybrid work flexibility and extensive family support benefits.
Required Skills
Education
PhD or MD in Biotechnology, Virology, Cell-Engineering, Pharmaceutical Technology, or a related scientific field.
Experience
- Several years of professional industry experience in Cell or Gene Therapy Quality Assurance
- Professional experience with manufacturing processes and release criteria for CGT products
- Demonstrated experience in regulatory interactions and GxP/ATMP compliance
- Leadership experience in managing matrixed organizations and cross-functional teams
- Experience with quality audits and commercial readiness activities
- Proven track record in developing and implementing global quality processes
Languages
Additional
- Locations available in Berlin, Leverkusen, or Wuppertal-Elberfeld. Role requires the ability to lead in a matrixed organization and facilitate FDA inspection readiness for ATMP facilities.
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