About Us
King’s College London (KCL) and its partner NHS Trusts - King’s College Hospital (KCH) and Guy’s & St Thomas’ Hospital (GSTT) together have one of the largest chimeric antigen receptor T (CAR-T) cell programmes in the UK with licensed and experimental CAR-T products being administered for patients with B-cell leukaemias, lymphomas, multiple myeloma, solid tumours and autoimmune disease.
The Cell Therapy Unit (CTU) at KCH, Denmark Hill is a GMP facility manufacturing Advanced Therapies Medicinal Products (ATMPs), including Hepatocytes, Islet cells, Mesenchymal Stromal Cells and CAR-T cells. The CAR-T manufacturing group was set up in 2025 to manufacture investigational CAR-T products for the treatment of patients with cancer and autoimmune disease in early phase clinical trials. pCAR19 lymphoma study is a first-in-human CAR-T trial for relapsed refractory B-cell lymphomas funded by Cancer Research UK and due to open in 2027.
KCL Gene Therapy Vector Facility (GTVF) provides GMP-grade viral vector manufacturing services including lentiviral vector, retroviral vector and adeno-associated viral vector production for early-phase clinical trials.
About The Role
This is a Senior Quality Manager role for the King’s CAR-T manufacturing group who will be responsible for all Quality aspects of CAR-T manufacturing for the phase 1 pCAR19 lymphoma trial due to open in 2027. Support for other CAR-T trials being conducted by this group (including at GSTT) may also be required.
The Senior Quality Manager will work within the Quality Assurance team (QA) of GTVF to ensure all activities related to the manufacture, import, testing and release of cell and gene based products meet the quality standards 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 Manager will take on the day-to-day management of key quality systems such as deviation and CAPA, batch release and change control. The role holder will ensure the systems are in a state of control and are meeting established quality KPIs. Performing 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.
The Senior Quality Manager will undertake the review and sign off of batch manufacturing documentation in preparation for release of IMPs and ATMPs.
The Senior Quality Manager will work closely with the Head of Quality and Quality Managers to drive continuous improvement of the Pharmaceutical Quality System and implement actions arising from regulatory inspections and customer audits. The role holder will take a key role in regulatory inspections (MHRA and HTA) client audits, leading on areas for which the position takes responsibility. They will also need to develop strong working relationships with the KCH CTU Quality Director, Quality Managers on the MHRA licences and KCH Stem Cell Transplant & CAR-T Quality lead to support regulatory compliance across the groups and sites.
The Senior Quality Manager will be an integral member of the Quality Assurance team and work with team members across the whole of GTVF, including from Process Development, Production, Technical and Quality Control. They will provide leadership and direction to the QA team and mentor QA team members as required.
The Senior Quality Manager will be responsible to the Head of Quality and act as Designee, when required, for the Head of Quality.
£53,947 including London Weighting
