Qualified Person (QP) – Pharmaceutical Batch Release

About the role

We are seeking a Qualified Person (QP) to join our Berlin‑based pharmaceutical manufacturing site. Reporting to the Head of Quality, you will be the key contact for authorities and will drive the release of investigational medicinal products (IMPs) while continuously improving quality processes.

Key responsibilities

• Perform batch release and generate all required documentation for IMPs.
• Communicate with local and international health authorities regarding product release and compliance.
• Collaborate cross‑functionally with manufacturing, R&D, and regulatory teams.
• Compile quality reports, document findings, and present results to stakeholders.
• Qualify and manage external vendors to ensure compliance with quality standards.
• Conduct root‑cause investigations and risk analyses.
• Support internal and external audits, preparing evidence and corrective actions.

Required profile

• Registered as a Sachkundige Person according to the German AMG.
• Experience with batch release of IMPs (14‑batch experience is a strong advantage).
• Proven ability to challenge and optimise existing quality processes.
• Strong knowledge of QA processes and regulatory requirements.
• Fluent in German and English, both written and spoken.
• Excellent communication and organisational skills.

Required skills

• Quality Management Systems (QMS) operation
• Regulatory compliance for pharmaceutical products
• IMP batch release procedures
• Root‑cause and risk analysis methodologies
• Vendor qualification processes

What we offer

• Opportunity to work in a state‑of‑the‑art facility within a global, innovation‑driven company.
• Collaborative environment with cross‑functional teams.
• Professional development in pharmaceutical quality and regulatory affairs.