Manager CMO Quality Lead (EMEA)

Santen is seeking a Manager CMO Quality Lead (EMEA) to act as the quality interface for assigned Contract Manufacturing Organizations (CMOs) and partners in EMEA, ensuring effective operational quality oversight and coordination for externally manufactured pharmaceutical products and biologic products.

Requirements

• 7–10 years of experience in the pharmaceutical industry, including at least 5 years in aseptic manufacturing within a multinational environment
• B.Sc. or M.Sc. in Biology, Pharmacy, Chemistry, or a related scientific discipline
• Fluent in English (written and spoken) with French required for interaction with French CMOs
• Strong knowledge of biologics manufacturing, including drug substance production and cell banking, with a solid understanding of sterile/aseptic processes and EU GMP requirements
• Experience working with Contract Manufacturing Organizations (CMOs) and within cross-functional, matrix organizations
• Structured problem-solving skills with sound judgment and the ability to manage multiple operational topics in parallel
• Strong collaboration and relationship-building skills in an international environment; proactive, flexible, well-organized, and detail-oriented
• Advanced proficiency in MS Office (Word, Excel, PowerPoint, Outlook, SharePoint, Visio) and strong user experience with TrackWise (QM) and Veeva Vault

Tagged as: Excel