Manager Qualification & Validation / GMP Production Manager | Biochemiker (m/w/d)

Job Summary

This role involves managing qualification and validation activities within the GMP production environment for an innovative biopharmaceutical company specializing in advanced stem cell therapies (ATMPs). The successful candidate will be responsible for creating and reviewing critical documentation, including SOPs, risk analyses, and specifications, and managing CAPA, deviation, and change control procedures. Key responsibilities also include drafting and reviewing validation and qualification plans/reports, executing equipment qualifications, and overseeing maintenance and calibration activities. Candidates must possess a degree in natural sciences (e.g., Biochemistry, Biotechnology) and substantial professional experience in the pharmaceutical industry, particularly with ATMPs and regulatory guidelines (EMA/FDA). This position is ideal for a highly motivated professional seeking to contribute to cutting-edge medical advancements in a growing, quality-focused organization.