Senior Quality Manager CMO - Monoclonal Antibody Manufacturing | Biotechnologist (m/w/d)

Job Summary

This Senior Quality Manager role at Daiichi Sankyo Europe GmbH involves overseeing quality aspects at Contract Manufacturing Organizations (CMOs), specifically for monoclonal antibody manufacturing. The successful candidate will be the primary quality contact for CMOs, ensuring adherence to Daiichi Sankyo's GMP/GDP standards and regulatory requirements for oncology products. Key responsibilities include managing quality oversight, defining and tracking CAPAs, reviewing and approving critical documents, and preparing Quality Assurance Agreements. The role also involves supporting new manufacturing processes, site transfers, and acting as a quality subject matter expert during PPQ and validation. This position requires global collaboration, information sharing, and active participation in the continuous improvement of the corporate Quality Management System, making it ideal for a detail-oriented professional passionate about pharmaceutical quality.