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.
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Quality Assurance Operations Manager Arbeitgeber: Metric Bio
Metric Bio bietet eine dynamische und innovative Arbeitsumgebung in Berlin, wo Mitarbeiter die Möglichkeit haben, an der Spitze der Gesundheits- und Biotechnologie zu arbeiten. Mit einem starken Fokus auf Teamarbeit und interdisziplinäre Zusammenarbeit fördert das Unternehmen eine Kultur des kontinuierlichen Lernens und der persönlichen Entwicklung. Die hybriden Arbeitsmodelle ermöglichen es den Mitarbeitern, flexibel zu arbeiten und gleichzeitig an bedeutenden Projekten im Bereich der präzisen Medizin mitzuwirken.