Quality Assurance Operations Manager

Metric Bio; Bayern; On-site; EUR 90,000 - 120,000; Full time

Job summary

Metric Bio is partnering with a global CDMO to appoint a QA Operations Lead at a flagship drug product manufacturing site in Germany. You will own deviations, CAPAs and investigations, driving timely quality events resolution and ensuring robust GMP compliance across sterile operations.

The role involves partnering with Manufacturing, MSAT, Engineering and QC to resolve issues, review batch records, and support audit readiness within a heavily regulated environment.

Qualifications

• Leading and overseeing deviations, CAPAs and root cause investigations.
• Driving timely resolution of quality events and ensuring effective corrective and preventive actions.
• Supporting shopfloor QA activities and maintaining GMP compliance across manufacturing operations.
• Reviewing quality trends and identifying recurring issues to drive continuous improvement.
• Supporting batch record review, documentation and quality oversight.
• Working closely with Manufacturing, MSAT, Engineering and QC to resolve quality issues and strengthen compliance.
• Supporting audit readiness and ensuring robust quality systems are maintained across the site.

Responsibilities

• Leading and overseeing deviations, CAPAs and root cause investigations.
• Driving timely resolution of quality events and ensuring effective corrective and preventive actions.
• Supporting shopfloor QA activities and maintaining GMP compliance across manufacturing operations.
• Reviewing quality trends, identifying recurring issues and driving continuous improvement.
• Supporting batch record review, documentation and quality oversight.
• Collaborating with Manufacturing, MSAT, Engineering and QC to resolve quality issues.
• Supporting audit readiness and ensuring robust quality systems are maintained across the site.

Skills

Deviations management

CAPA investigations

Root cause analysis

GMP compliance

Quality systems

Batch record review

Cross-functional collaboration

Job description

We're partnering exclusively with a global CDMO to appoint a QA Operations Lead at one of their flagship drug product manufacturing sites in Germany.

This is an opportunity to join a site undergoing significant investment and expansion, taking ownership of key quality operations activities across a GMP-regulated sterile manufacturing environment, with a particular focus on deviations, CAPAs and investigations.

The Role

As QA Operations Lead, you'll be responsible for:

• Leading and overseeing deviations, CAPAs and root cause investigations.
• Driving timely resolution of quality events and ensuring effective corrective and preventive actions.
• Supporting shopfloor QA activities and maintaining GMP compliance across manufacturing operations.
• Reviewing quality trends, identifying recurring issues and driving continuous improvement.
• Supporting batch record review, documentation and quality oversight.
• Working closely with Manufacturing, MSAT, Engineering and QC to resolve quality issues and strengthen compliance.
• Supporting audit readiness and ensuring robust quality systems are maintained across the site.

Why this opportunity?

• Join a global CDMO with an established international manufacturing network.
• Work within a state-of-the-art large-molecule sterile fill/finish facility.
• Be part of a site undergoing significant investment, capacity expansion and long-term growth.
• Take ownership of critical quality processes and make a tangible impact on GMP compliance and operational performance.

We're looking to speak with QA professionals from biologics, sterile manufacturing or CDMO environments who have hands-on experience managing deviations, CAPAs and investigations within GMP-regulated manufacturing.