Lead Quality Assurance Specialist

3 weeks ago

London, Greater London, United Kingdom King's College London Full time
Position Overview

The King's College London Gene Therapy Vector Facility (GTVF) is a premier provider of GMP-grade viral vector manufacturing services. Our offerings include the production of Lentiviral Vectors (LV), Retroviral Vectors (RV), and Adeno-Associated Viral Vectors (AAV) for early-phase clinical trials, complemented by significant initiatives in process innovation, knowledge transfer, and training to mitigate critical skills shortages.

Role Responsibilities

The Senior Quality Officer will be an essential member of the Quality Assurance (QA) team, ensuring that all operations within the GTVF related to the production, testing, and release of GMP-grade viral vectors adhere to the quality standards established in the Quality Manual and relevant external regulations.

Key responsibilities include:

  • Leading investigations and resolutions of deviations and quality exceptions in collaboration with Production and Quality Control teams, including the formulation of corrective and preventative actions and tracking their implementation.
  • Overseeing supplier qualification processes and executing QA sign-offs for operator validations.
  • Conducting preliminary reviews of Batch Manufacturing Records, Quality Control Records, and Media Fill Records.
  • Authorizing the use of manufacturing suites.
Collaboration and Continuous Improvement

The Senior Quality Officer will work closely with the Head of Quality and Quality Managers to foster continuous enhancement of the Pharmaceutical Quality System. This role is pivotal in engaging with team members across the GTVF, including Research & Development, Production, Technical, and Quality Control departments.

Qualifications and Skills

The ideal candidate will possess:

  • A solid understanding of Pharmaceutical Quality Systems in accordance with ICH Q10, particularly in areas such as Change Control, Document Control, Deviations, CAPA, and supplier qualification.
  • Experience in operational Quality Assurance, particularly in the production or Quality Control of cell therapies, cell biology, immunology-based research, or vaccines.
Commitment to Diversity

We value diversity and strive to create an inclusive environment where everyone feels connected and valued within our community.

This position is full-time (35 hours per week) and offers an indefinite contract.

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