Manager Qualification & Validation / GMP Production Manager | Manager Qualification & Validation* / Produktionsmanager GMP*

Job Summary

This role is ideal for a scientifically-minded professional passionate about advancing innovative stem cell therapies within the biopharmaceutical sector. As the Manager of Qualification & Validation and GMP Production, you will be crucial in ensuring the highest quality standards for Advanced Therapy Medicinal Products (ATMPs). Day-to-day responsibilities include drafting and reviewing critical quality documents such as SOPs, risk analyses, and specifications, managing CAPA measures, deviations, and change control procedures. A core focus will be on developing and reviewing validation plans and reports, conducting equipment qualifications, and overseeing maintenance and calibration activities. You will also contribute significantly to preparing regulatory submissions for major authorities like the FDA and EMA and support official inspections. Success requires a strong background in life sciences, profound knowledge of EMA and FDA guidelines for ATMPs, and proven expertise in process validation and equipment qualification, combined with excellent German and professional English skills.