Senior Quality Assurance Officer
4 weeks ago
About Us
The King's College London Gene Therapy Vector Facility (GTVF) is dedicated to providing top-tier GMP-grade viral vector manufacturing services. Our offerings encompass the production of Lentiviral Vector (LV), Retroviral Vector (RV), and Adeno-Associated Viral Vector (AAV) for early-phase clinical trials, along with significant initiatives in process innovation, knowledge transfer, and training to address critical skills shortages.
In collaboration with the Network of Innovation Hubs, our mission is to leverage the UK's exceptional academic medical research to deliver groundbreaking gene therapies to patients, offering transformative solutions for previously untreatable conditions while fostering a dynamic economic environment.
About the Role
The Senior Quality Officer will be an integral part of the Quality Assurance team (QA), ensuring that all activities within the GTVF group related to the manufacturing, testing, and release of GMP-grade viral vectors adhere to the quality standards set forth in the Quality Manual and comply with external regulations, including UK statutory instruments, EU Good Manufacturing Practice (GMP), and Human Tissue Authority (HTA) guidelines.
This role involves leading investigations and resolutions of deviations and quality exceptions in collaboration with the Production and Quality Control teams. Responsibilities include determining corrective and preventative actions and monitoring their implementation. The Senior Quality Officer will also oversee supplier qualifications, perform QA sign-offs for operator validations, and conduct initial reviews of Batch Manufacturing Records, Quality Control Records, and Media Fill Records.
Conducting internal and external audits is a key responsibility, which includes preparing checklists, drafting audit reports, reviewing proposed corrective actions, and ensuring follow-up on the completion and closure of audits. Additionally, the Senior Quality Officer will authorize the use of manufacturing suites.
Collaboration with the Head of Quality and Quality Managers is essential to drive continuous improvement within the Pharmaceutical Quality System. The Senior Quality Officer will work closely with team members across the GTVF group, including R&D, Production, Technical, and Quality Control. This position reports directly to the Head of Quality.
This role offers a unique opportunity to gain a comprehensive understanding of various aspects of cell and gene therapy and Pharmaceutical Quality Systems.
About You
To excel in this position, candidates should possess the following skills and experience:
Essential Criteria
- Proficient knowledge of a Pharmaceutical Quality System in accordance with ICH Q10, particularly in Change Control, Document Control, Deviations, CAPA, and supplier qualification. Capable of delivering Good Manufacturing Practice training.
- Experience in an ATMP/IMP/Biopharm/Vaccines manufacturing environment.
- Background in operational QA, including the review of pre-executed batch records, executed batch records, and validations or media fills.
- Experience in conducting supplier qualifications, including supplier audits.
- Proven experience in managing internal and external audits.
- Exceptional organizational skills with a demonstrated ability to prioritize and manage competing demands. Strong verbal and written communication skills.
Desirable Criteria
- Experience in a MHRA/HTA/FDA licensed environment.
- Hands-on experience in the production or QC of cell therapies or in cell biology/immunology-based research/vaccines.
Salary range: £43,205 to £50,585 per annum, inclusive of London Weighting Allowance.
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