Quality Manager

About the role

The Cell and Gene Therapy, King's group manufactures a variety of Advanced Therapy Medicinal Products (ATMPs) and starting materials, in state-of-the-art Good Manufacturing Practice (GMP) facilities for treatment of cancer and rare diseases. This post supports the translation of cutting-edge medical research into clinical application.

The Quality Manger will be expected to work on site and work within the Quality Assurance team (QA) to ensure all activities within the Cell and Gene Therapy (CGT) group related to the manufacture, import, testing and release of cell and gene based products meet the quality standards of the CGT 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 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 Quality Manger will undertake the review and sign off of batch manufacturing documentation in preparation for release of IMPs and ATMPs and viral vectors as starting materials for further manufacturing under GMP.

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 Cell Therapy Unit Quality Director and Quality Managers on the MHRA licences to support regulatory compliance across the groups and sites.

The Quality Manager will be an integral member of the Quality Assurance team and work with team members across the whole of the CGT group 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 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, 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

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

Desirable criteria

• Hands on experience in production of cell therapies or cell biology or biopharms or immunology
• Project management

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