Walker Cole International is searching for a Head of Quality Operations to join a Cell & Gene Therapy business based in Scotland. This role would act as the Quality number two on site, critical in ensuring all operational activities are done in compliance with cGMP regulations.
You will be responsible for:
* Motivating, coaching and developing the team of Quality Assurance professionals
* Supporting the QPs with the review and approval of batch documentation, ensuring timely product release
* Working closely with the Site Quality Director to devise and execute the site Quality strategy and drive business performance
* Establishing and maintaining relationships with EU and other regulatory authorities to ensure the business is represented appropriately
The successful candidate will have:
* A BSc (or equivalent) within the Life Sciences, Biotech, Pharmacy or related field
* Extensive previous leadership experience, with a proven record of mentoring and developing junior team members
* Strong knowledge of required regulations and guidelines, specifically within sterile and biotech environments
* Hands-on experience working on a manufacturing site
Quality Assurance | QA | Pharmaceutical | CAPA | Corrective and Preventative Action | Quality | Batch Release | GMP | Good Manufacturing Practice | Operational | IMP | Investigational Medicinal Product | Commercial | Sterile | Biopharmaceutical | ATMP | Advanced Therapy Medicinal Product | Head of Quality | Senior Quality Manager | Quality Director