Qualified Person (QP) – Pharmaceutical Quality Release

About the role

The company is a global, innovation‑driven pharmaceutical organization with a state‑of‑the‑art facility in Berlin. Reporting to the Head of Quality, the Qualified Person (QP) will lead batch release activities for investigational medicinal products (IMPs) and serve as the primary liaison with health authorities.

Key responsibilities

• Perform batch release and prepare related documentation for IMPs.
• Communicate with local and international health authorities on quality matters.
• Collaborate cross‑functionally with multiple departments to ensure compliance.
• Compile quality reports and document findings.
• Qualify and manage external vendors.
• Conduct root cause and risk analyses.
• Support internal and external audits.

Required profile

• Recognised as a Sachkundige Person according to the German AMG.
• Experience with batch release of IMPs (14 batches preferred).
• Ability to challenge and optimise existing quality processes.
• Fluent in German and English.
• Strong organisational and communication skills.

Required skills

• Batch release
• Quality Assurance processes
• Root cause analysis
• Risk analysis
• Vendor qualification