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X4 are currently collaborating with a ground breaking Cell and Gene company in the search for a highly skilled QA Operations Team Manager to join their London based team! The incoming individual will be responsible for providing oversight of the Quality Management System and managing and training the QMS team.
The role is site based, in London and depending on experience level we're looking at £60,000-£65,000 per annum.
Your responsibilities:
- Lead, guide and manage the QA Operations and Document Control team, ensuring efficient daily operations and fostering continuous improvement.
- Develop, oversee and manage the internal audit/self- inspection schedule for the site. Ensure timely execution, reporting and follow-up on findings to maintain inspection readiness.
- Approve and support investigations into significant quality events and CAPAs.
- Review batch records promptly to facilitate timely batch releases.
- Create, review and approve relevant GMP documentation.
- Act as the main point of contact for external partners, specifically regarding quality events and out-of-specifications.
- Oversee, review and manager risks, quality events (including incidents, deviations, investigations, change controls and CAPAs), ensuring timelines are met.
Your experience:
- Leadership and team development experince.
- Relevant Science based degree e.g. Chemistry, biology, Pharmacy.
- Experince working in a GxP environment including a minimum 6 years experince in Compliance and Quality Assurance.
- Working and hands on experince with defining and implementing Quality Management systems.
- IT literate, experience managing and operating and electronic QMS.
Please share you CV at e.smailes@x4 lifesciences.com if you are interested in hearing more about the position. As always if anyone in your network may be a good fit, please share their details as we offer a referral bonus upon the successful placement.
