Product Quality and Regulatory Lead

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.

About You

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

Essential Criteria

• Higher degree in a relevant science, or life science discipline
• Experience working in IMP / commercial pharmaceutical organisations within GMP Pharma/Biotech/Contract Manufacturing organisation (CMO) sectors compliant with MHRA, EU and FDA requirements
• Experience in preparation of IMPDs for cell and gene therapy based clinical trials and the management of regulatory requests for information
• Extensive knowledge of QA and QC systems and techniques for cell and gene therapy products and management of change e.g., incoming materials, bioreactors
• Strong leadership and interpersonal skills. Significant experience of building and leading a team. Excellent verbal and written communication skills.
• Experience of setting up systems and processes for the manufacture, test, pack release of drug product for early phase clinical trials
• Experience in project management techniques applied to inspection readiness and managing action plans in response to regulatory changes
• High level of work organization, agility, self-motivation, drive for performance and improvement and understanding of risk based approach in advanced therapies / biotech field

Desirable criteria

• Experience and knowledge of process development and change management of cell and gene therapy products / Biopharm. Including implementation of control strategies.
• Eligible Qualified person .

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 next page after you click “Apply Now”. This document will provide information of what criteria will be assessed at each stage of the recruitment process.

Further Information

We pride ourselves on being inclusive and welcoming. We embrace diversity and want everyone to feel that they belong and are connected to others in our community.

We are committed to working with our staff and unions on these and other issues, to continue to support our people and to develop a diverse and inclusive culture at King’s.

We ask all candidates to submit a copy of their CV, and a supporting statement, detailing how they meet the essential criteria listed in the advert. If we receive a strong field of candidates, we may use the desirable criteria to choose our final shortlist, so please include your evidence against these where possible.

To find out how our managers will review your application, please take a look at our ‘ How we Recruit’ pages.

Grade and Salary: £64,139 – £73,529 per annum, including London Weighting Allowance

Job ID: 109725

Close Date: 30-Mar-2025

Contact Person: Simone Skeene

Contact Details: [email protected]