Quality Manager – Pharmacist (m/f/d)

About the role

As a Quality Manager with a pharmacy background, you will act as the primary quality liaison for Contract Manufacturing Organizations (CMOs) supporting Daiichi Sankyo’s oncology portfolio. You will ensure that all CMO activities meet Daiichi Sankyo’s GMP/GDP standards and regulatory requirements.

Key responsibilities

• Lead quality oversight at CMOs, guaranteeing compliance with internal standards and international GMP guidelines.
• Manage quality topics such as change control, deviations, and product complaints.
• Monitor and drive timely implementation of CAPAs linked to audit findings or deviations.
• Review, evaluate, and approve critical quality documents, ensuring stakeholder involvement.
• Assist CMO Quality Managers during authority inspections at supplier sites.
• Collect, process, and distribute quality data from CMOs according to SOPs.
• Collaborate with global QA teams and cross‑functional departments (Supply Chain, Technical Management, Regulatory Affairs) to maintain a consistent supply of high‑quality products.
• Contribute to the continuous improvement of the corporate Quality Management System (QMS) and SOP landscape.

Required profile

• Bachelor’s degree in natural or pharmaceutical sciences with at least 3 years relevant experience, or vocational training in pharmaceutical business with at least 6 years experience.
• Minimum 3 years in the pharmaceutical industry, including at least 1 year in Quality Assurance/Quality Management.
• At least 2 years working in a GxP manufacturing environment.

Required skills

• Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) knowledge.
• CAPA management.
• Change control processes.
• Deviation and complaint handling.
• Quality document review and approval.
• Experience with authority inspections.
• Data collection and reporting according to SOPs.