Qualified Person – IMP Certification & QA Lead

About the role

We are seeking a Qualified Person (QP) to lead investigational medicinal product (IMP) certification and quality assurance across our clinical supply chain in Germany. The role serves as a regulatory anchor, ensuring compliance for packaging, cold‑chain logistics, and global distribution of international clinical trials.

Key responsibilities

• Assume full legal accountability for batch release decisions 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 consultancy to enterprise clients.
• Oversee QA aspects of complex client projects from onboarding through execution, collaborating with external stakeholders.

Required profile

• University degree in Pharmacy with 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 qualitative/quantitative analysis and medicinal product testing.
• Fluent in German and English at a professional level.

Required skills

• Pharmaceutical quality control
• Qualitative analysis
• Quantitative analysis
• Medicinal product testing

What we offer

• Structured onboarding and clear global career progression.
• Competitive salary package with a company pension scheme.
• Diverse, values‑driven culture focused on integrity, innovation, and cross‑functional collaboration.
• Hybrid work model based in the Freiburg area.