Product Quality and Regulatory Lead

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.  

The GTVF is run by a large, industry-leading team of >50 people who have extensive experience in delivering end-to-end viral vector manufacture for both academic and commercial clients, with a focus on early-stage clinical trials.

About the role

GTVF is a CMO for the manufacture of early phase viral vector for drug substance and drug product. The group manufactures retroviral vector, lentiviral vector and AAV.

Quality Lead  - New product introduction / Regulatory Affairs for the Gene Therapy Vector Facility (GTVF) at Kings is a new role which will have responsibility for the new product quality management related to Gene Therapy GMP manufacturing activities for drug product and drug substance and analytical.

The post holder will work with colleagues in Production, Quality Assurance, Project Management, Business Development, Process and Analytical Development, to ensure that product lifecycle, process validation, tech transfer is set up and managed according to ICH requirements and that GTVF remain upto date with the latest regulatory requirements, and lead inspection readiness campaigns

Establish systems to manage the registered details and operate in accordance with the pharmaceutical quality system. Manage licence variations.

The successful candidate will report to the Director of Quality . The post holder may lead a team in the future or improvement project involving a matrix management approach.

The function will be responsible for aspects of the PQS related to product quality, manage audits and inspections, monitor and report on compliance activities, manage the quality risk management process and implement improvements and regulatory requirements as required.

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

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