Senior Quality Manager for Product Lifecycle Projects | Senior Qualitätsmanager (m/w/d) für Produktlebenszyklus-Projekte

Job Summary

This Senior Quality Manager role is crucial for ensuring compliance and quality throughout the product lifecycle, focusing primarily on medical and pharmaceutical products under stringent GMP regulations. The core responsibilities involve creating and maintaining GMP specifications for raw materials and final products, executing supplier and external service provider qualifications, and managing Quality Assurance Agreements with contract manufacturers. Day-to-day duties include handling Change Control applications, reviewing validation documents and manufacturing instructions, conducting Quality Reviews for various components, and managing deviations, complaints, and CAPA processes during product introduction. The ideal candidate must hold a scientific degree (preferably PhD in Chemistry, Pharmacy, or Biology) and possess deep expertise in ISO 13485 for medical devices, GMP, and related quality/risk management standards (e.g., EXCiPACT, IPEC-GMP). This position requires strong analytical and problem-solving capabilities, project management acumen, and excellent German and English language skills, serving as a central quality contact point supporting innovation and production at the Darmstadt site.