Senior Quality Manager (m/f/d) – Focus on PQR / URS / Large-Scale Production

Responsibilities:

• Creation, review, and further development of Product Quality Reviews (PQRs) and Annual Product Reviews (APRs)
• Development, coordination, and maintenance of User Requirement Specifications (URS) for equipment, processes, or quality-related systems
• Close collaboration with internal departments such as Production, QA, QC, Engineering, Validation, and Regulatory Affairs
• Assisting in ensuring GMP compliance within commercial or industrial-scale production
• Evaluating and addressing deviations, change controls, and CAPAs in the production-related quality environment

Qualifications:

• Bachelor’s or master’s degree in chemistry, pharmacy, biotechnology, process engineering, or a related field
• Several years of professional experience in a GMP-regulated environment, ideally in the pharmaceutical, biotech, or chemical industry
• Substantial practical experience in the preparation of PQRs and APRs
• Experience in developing URS documents