QA Operations Team Manager
£60,000 - £65,000
Permanent
We're searching for an exceptional QA Operations Team Manager to lead our clients Quality Assurance team and ensure their innovative products meet the highest global regulatory standards. This is an exciting opportunity to lead a high-performing team and drive quality across our UK operations, while also providing support to sites in Ireland and the USA.
Responsibilities:
- Lead, manage, and train the QA Operations and Document Control teams
- Provide leadership and direction to the QA Operations and Document Control teams
- Serve as the primary contact for all operational issues
- Develop and manage the site’s internal audit/self-inspection schedule, ensuring timely execution, reporting, and follow-up for inspection readiness
- Approve and support investigations into significant quality events and CAPA
- Offer training and support for quality systems across the UK, USA, and Ireland
- Ensure timely review of batch records for efficient batch release
- Generate, review, and approve relevant GMP documentation
- Ensure compliance with EU and FDA regulations to retain MIA(IMP) and MS licenses
- Serve as SME for Quality Management System and documentation processes during audits
- Participate in Tier 2 meetings, representing the QMS Team and escalating issues to the Quality Director
- Oversee the management of risks, quality events, incidents, deviations, investigations, change controls, and CAPA
- Coordinate regulatory inspection preparation and support activities as directed by the Quality Director.
- Develop and deliver GxP compliance training in operational areas.
- Ensure compliance with GMP, Data Integrity, and Good Documentation Practices (GDP) in all work
To succeed in this role, you will bring:
- A science-based degree in Chemistry, Biology, Pharmacy, or a related field
- 6+ years of experience in Compliance and Quality Assurance within GxP environments
- Proven leadership experience in a sterile/aseptic GMP manufacturing environment, with the ability to develop and mentor a team
- Expertise in GMP regulations (EU, UK, US) and hands-on experience with managing electronic QMS systems and regulatory audits
- Able to work in a fast-paced environment
With a state-of-the-art manufacturing facility and global operations, you’ll be working with some of the best minds in the industry.
Ready to make an impact on the future of healthcare? Apply now