- The RoleAs 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.
If you'd be interested in learning more, or know someone who may be a good fit, please send me a direct message for a confidential discussion.
Requirements added by the job poster
• 5+ years of Pharmaceutical Manufacturing experience
• 5+ years of experience in Quality Assurance