Senior Quality Officer

About us

The King’s College London Gene Therapy Vector Facility (GTVF) provides comprehensive GMP-grade viral vector manufacturing services. This includes Lentiviral Vector (LV), Retroviral Vector (RV) and Adeno-Associated Viral Vector (AAV) production for early-phase clinical trials, alongside substantial programmes in process innovation, knowledge transfer and training to address critical skills shortages. 

In partnership with the Network of Innovation Hubs, our vision is to ensure that the UK capitalises on its outstanding academic medical research to deliver novel gene therapies to patients, providing transformative treatments for currently intractable conditions, and generating a vibrant economic landscape. 

About the role

The Senior Quality Officer will work within the Quality Assurance team (QA) to ensure all activities within the GTVF group related to the manufacture, testing and release of GMP grade viral vectors meet the quality standards of the GTVF group as outlined in the Quality Manual and external standards e.g. UK statutory instruments, EU Good Manufacturing Practice (GMP) and Human Tissue Authority (HTA) regulations.

The Senior Quality Officer will take a lead role in the investigation and closeout of deviations and quality exceptions in conjunction with the Production and QC teams including determining corrective and preventative actions and monitoring their progress. They will lead on supplier qualification perform the QA sign off of operator validations and carry out initial reviews of Batch Manufacturing Records, Quality Control Records and Media Fill Records.

Lead internal and external audits including preparation of checklists, preparation of audit reports, review of proposed corrective actions and follow up on completion and closeout of the audit will form a key aspect of the role. In addition, the Senior Quality Officer will perform authorisation of the manufacturing suites for use.

The Senior Quality Officer will work closely with the Head of Quality and Quality managers to drive continuous improvement of the Pharmaceutical Quality System and will be an integral member of the Quality Assurance team and work with team members across the whole of the GTVF group including R&D, Production, Technical and Quality Control.  The Senior Quality Officer will be responsible to the Head of Quality.

This position provides an opportunity to develop a good understanding of a wide range of cell and gene therapy and Pharmaceutical Quality Systems.

This is a full-time post (35 hours per week), and you will be offered an indefinite contract.

About you

To be successful in this role, we are looking for candidates to have the following skills and experience:

Essential criteria 

1. Working knowledge of a Pharmaceutical Quality System according to ICH Q10 in particular Change Control, Document Control, Deviations and CAPA, and supplier qualification. Deliver Good Manufacturing Practice training.
2. Experience of working in an ATMP/ IMP / Biopharm / Vaccines manufacturing setting.
3. Experience in operational QA e.g., review pre-executed batch records, executed batch records and validations or media fills. 
4. Experience in performing supplier qualification including supplier audits 
5. Experience in performing and managing internal and external audits 
6. Excellent organisational skills with a demonstrable ability to balance competing demands and priorities. Good verbal and written communication skills. 

Desirable criteria

1. Experience in working a MHRA / HTA / FDA  licenced environment.
2. Hands on experience in production or QC of cell therapies or cell biology / immunology-based research / vaccines.

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