Head of Qualified Person Support

Responsibilities

• Lead the Qualified Person (QP) Support team in Munich, providing both functional and disciplinary leadership.
• Ensure GMP and regulatory compliance for the release of commercial medicines and clinical trial products (IMP) in accordance with AMG, AMWHV, and EU-GMP.
• Manage the decision-making process for the release or rejection of raw materials, packaging, intermediates, and finished products.
• Coordinate new registrations, supplier qualifications, and release investigations.
• Oversee the entire supply chain, including validations, stability testing, and retention sample management.
• Manage and evaluate quality events, including deviations, changes, complaints, and APR/PQR.
• Act as a key interface with regulatory authorities and internal departments such as Regulatory, Supply Chain, and Technology Development.
• Prepare for and support audits, inspections, and regulatory authority visits.

Requirements

• Completed Pharmacy degree with a valid pharmacist license (Approbation).
• Mandatory Qualified Person (QP) certification per §14 AMG.
• Extensive experience in the release of both commercial medicinal products and Investigational Medicinal Products (IMP).
• Deep knowledge of EU-GMP regulations and clinical requirements (CTR, Annex 13 & 16).
• Proven leadership experience in managing and developing professional teams.
• Experience in supplier qualification and auditing CMOs, CROs, and laboratories.
• Strong process management skills and experience handling high-level audits and inspections.
• Fluent English communication skills.

About the Company

Daiichi Sankyo is a global healthcare company dedicated to improving lives through innovative medicines. With a legacy dating back to 1899 and a presence in over 30 countries, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. We foster a culture of mutual respect, inclusion, and continuous learning to shape a healthier future for patients worldwide.