Senior Quality Manager CMO - Drug Substance Manufacturing | Biologist (m/w/d)

Job Summary

This Senior Quality Manager role is a pivotal position for an experienced professional passionate about ensuring the highest quality standards in drug substance manufacturing. The successful candidate will serve as the primary quality contact for Contract Manufacturing Organizations (CMOs), overseeing all quality-related activities from change control and deviations to complaint management. This role involves defining and tracking CAPAs, reviewing and approving critical documents like APQRs, and preparing/negotiating Quality Assurance Agreements. The position requires active participation in establishing new manufacturing processes, site transfers, and supporting validation activities, while also conducting audits and assisting CMOs during authority inspections. This global role demands close collaboration with various departments to maintain consistent product supply and contribute to the continuous improvement of the corporate Quality Management System.