Senior Quality Manager

King's College London; City Of London; On-site; GBP 70,000 - 100,000; Full time

Job summary

King's College London is recruiting a Senior Quality Manager for the CAR-T manufacturing group to oversee all quality activities for the phase 1 pCAR19 lymphoma trial due to open in 2027, with potential support across GSTT.

You will lead QA systems, deviations, CAPA, batch release, and change control, perform audits, and drive continuous improvement of the Pharmaceutical Quality System, coordinating with MHRA and HTA inspections.

Qualifications

• BSc or MSc in a relevant science discipline.
• Experience in GMP-regulated environment, preferably cell and gene therapy/Biopharm.
• Experience managing key Quality Management Systems (change control, deviations, audits, GMP training, SOPs).
• Proven ability to build strong stakeholder relationships.
• Experience mentoring staff.
• Equipment/Facility validation and data integrity assessment.
• Experience applying Quality by Design during manufacturing lifecycle.

Responsibilities

• Lead and manage QA activities for CAR-T manufacture and batch release.
• Own deviation and CAPA processes, change control and document review.
• Conduct internal and external audits; prepare reports and close actions.
• Drive continuous improvement of the Pharmaceutical Quality System.
• Support regulatory inspections (MHRA and HTA) and client audits.
• Mentor QA team members and collaborate with Heads of Quality and Licence holders.

Skills

Quality Assurance

Deviations management

CAPA management

Audits

Stakeholder management

Education

BSc or MSc in science

Job description

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) and 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.

This is a full time post (35 hours per week), and you will be offered a fixed term contract for 18 months*.*

About You

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

Essential criteria

1. BSc or MSc in a relevant science discipline.
2. Experience of working within a GMP regulated environment preferably in cell and gene therapy/Biopharm.
3. Experience in managing key Quality Management Systems e.g. change control, deviations, audit (internal/external), delivering GMP training, writing SOPs.
4. Demonstrated ability to build strong working relationships with stakeholders.
5. Experience in successfully managing or mentoring staff.
6. Equipment/Facility validation and data integrity assessment.
7. Experience in implementation of Quality by Design principles during manufacturing process development and lifecycle.

Desirable criteria

1. Hands on experience in production of cell therapies or cell biology or biopharms or immunology.
2. Experience with CAR-T cell manufacturing.

Downloading a copy of our Job Description

Full details of the role and the skills, knowledge and experience required can be found in the Job Description document, provided at the bottom of the page. This document will provide information of what criteria will be assessed at each stage of the recruitment process.

Further Information

At King's, we believe that the diversity of our community and a culture that is welcoming, open, inclusive and collaborative, are great strengths of the university.

The Equality Act of 2010 protects the rights of our students and staff and provides a framework to fulfil our duties to eliminate unlawful discrimination, harassment and victimisation and in addition, to advance equality of opportunity and foster good relations between those who share a protected characteristic and those who do not. At times, this will include balancing rights and beliefs that can feel in tension.

We are committed to free speech and to academic freedom, believing that our foundational purpose as a university, is to create spaces where a wide range of ideas, including ideas that are controversial, can be discussed and debated, and where members of our community can express lawful views without fear of intimidation, harassment or discrimination.

When engaging in the robust exchange of ideas, we ask that our community is mindful of our Dignity at King's guidance.