International Quality Management Director / Qualified Person | Biologe (m/w/d)

Job Summary

This high-impact leadership role involves overseeing the global quality strategy for a leading CDMO in regenerative medicine. Based in Neunkirchen am Brand, you will hold total responsibility for quality policies and management systems across sites in Germany, the UK, and New Zealand. Day-to-day, you will lead international Quality Assurance, Quality Management, and Quality Control teams, ensuring strict compliance with ISO 13485, FDA 21 CFR 820, MDR, and GMP standards. You will act as the primary liaison for regulatory authorities and notified bodies during inspections while managing core QMS processes such as CAPA, risk management, and process validation. A unique aspect of this role is the opportunity to serve as the Qualified Person (Sachkundige Person) according to § 14 AMG, directly influencing the safety of innovative implants and tissue preparations. This position is ideal for an experienced professional looking to drive a sustainable quality culture within a dynamic, international environment offering significant creative freedom and a generous remote work policy.