Quality Assurance Operations Manager

Role overview

This is an onsite quality leadership role based in Bavaria, Germany within a sterile drug product CDMO environment. The position sits at a flagship drug product manufacturing site that is receiving substantial investment and expanding its capabilities. It offers the chance to help strengthen quality standards across commercial biologics manufacturing and influence the direction of site quality operations.

Key accountabilities

• Oversee QA activities on the manufacturing shopfloor.
• Own and drive the handling of deviations, CAPAs and related investigations.
• Review batch records and maintain strong GMP oversight.
• Ensure the site stays ready for internal and external audits.
• Lead, coach and develop a high-performing QA Operations team.
• Work closely with Manufacturing, MSAT, Engineering and Quality Control to improve compliance and support continuous improvement.

What makes this role compelling

• Opportunity to join a global CDMO with an established international manufacturing network.
• Lead quality operations at a modern large-molecule fill/finish facility.
• Be part of a site undergoing significant investment, added capacity and long-term growth.
• Take on a highly visible leadership position that will help shape the future of quality operations.

Candidate profile

The employer is seeking an experienced QA Operations leader with a background in biologics, sterile manufacturing or CDMO settings. Strong experience leading shopfloor quality teams in GMP-regulated production environments is essential.

Additional information

This role is being recruited on an exclusive basis for a global CDMO. The position is for a head-of-operations quality leadership track within a sterile drug product manufacturing site in Germany. Interested candidates are invited to discuss the opportunity confidentially.