Director of Quality Assurance – Pharmaceuticals (Germany)
Barrington James · Berlin
Stellenbeschreibung
About the role
We are seeking an experienced Director of Quality Assurance to lead the QA function within a GMP‑regulated pharmaceutical environment in Germany. The role will shape QA strategy, ensure regulatory compliance, and drive continuous improvement across manufacturing and supply chain operations.
Key responsibilities
- Define and execute QA strategy and operational plans for manufacturing and supply chain.
- Maintain compliance with EU GMP, GDP and global regulatory standards.
- Oversee Quality Management System activities, including deviations, CAPAs, change controls and internal audits.
- Lead regulatory inspections and ensure inspection readiness.
- Collaborate with Manufacturing, Regulatory Affairs and Operations teams to align quality objectives.
- Develop, mentor and manage high‑performing QA teams.
Required profile
- Significant leadership experience in pharmaceutical quality assurance.
- Strong knowledge of EU GMP and related regulatory requirements.
- Proven track record managing inspections and quality systems.
- Excellent leadership and stakeholder management abilities.
- Fluent English; German language skills are desirable.
- QP eligibility is advantageous.
Required skills
- EU Good Manufacturing Practice (GMP)
- Good Distribution Practice (GDP)
- Quality Management System (QMS) administration
- Deviation handling and Corrective & Preventive Actions (CAPA)
- Change control processes
- Audit planning and execution
- Regulatory inspection management
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Barrington James
Berlin
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