Qualified Person (Pharmacist) – Clinical Supply Chain

About the role

We are a leading global scientific services organization seeking a Qualified Person (QP) to take legal responsibility for investigational medicinal product (IMP) certification and quality assurance across our clinical supply chain operations in Germany. The role serves as a regulatory anchor, ensuring compliance throughout packaging, cold‑chain logistics and worldwide distribution for international clinical trials.

Key responsibilities

• Assume full legal accountability for batch release and certification of IMPs in line with the German Medicinal Products Act (AMG) and EU GMP guidelines (Annex 13 & 16).
• Author QP declarations, approve SOPs, authorize contract laboratories and manage end‑to‑end complaint handling.
• Review, validate and approve deviation documentation, driving root‑cause analysis and systemic compliance.
• Lead national and international audits, act as primary liaison to regulatory authorities and provide QA expertise to enterprise clients.
• Support the full project lifecycle, overseeing QA aspects from onboarding through execution and coordinating with external stakeholders.

Required profile

• University degree in Pharmacy and a valid pharmacist licence (Approbation).
• Qualified Person status under §14/15 AMG (EU Directive 2001/83/EU).
• Minimum 2 years of hands‑on experience in pharmaceutical quality control, including quantitative/qualitative analysis and medicinal product testing.
• Practical exposure to pharmaceutical manufacturing environments.
• Full professional fluency in German and English.

Required skills

• Pharmaceutical quality control
• GMP compliance (EU Annex 13 & 16)
• Regulatory documentation and IMP batch release
• Risk assessment and analytical evaluation

What we offer

• Structured onboarding with clear global career progression pathways.
• Competitive salary package complemented by a company pension scheme.
• Diverse, values‑driven corporate culture focused on integrity, innovation and cross‑functional collaboration.