Senior Quality Manager, Contract Manufacturing Organization (Monoclonal Antibody) | Biotechnologist (m/w/d)

Job Summary

This senior role requires a highly qualified professional to serve as the primary quality contact and manager of quality oversight for Contract Manufacturing Organizations (CMOs) handling oncology products, specifically focusing on Monoclonal Antibody manufacturing. Day-to-day responsibilities include managing critical quality topics such as change control, deviations, and complaints, defining and tracking effective CAPAs, and independently reviewing and approving key documents like APQRs and PPQ reports. A crucial part of the role involves preparing and negotiating Quality Agreements (QAAs) with CMOs and ensuring compliance with DS quality standards (GMP/GDP) and regulatory requirements. The ideal candidate holds a Master's degree in Biotechnology or a related pharmaceutical science, possesses at least five years of relevant pharmaceutical experience, including specialized experience in GxP environments and monoclonal antibody manufacturing. Success in this position requires excellent international GMP/GDP knowledge, strong diplomatic communication skills, and a solution-oriented mindset to ensure consistent, high-quality product supply to global markets while contributing to the continuous improvement of the corporate Quality Management System.