Quality Assurance Manager – Cell and Gene Therapy Service
An excellent opportunity has presented itself at Cell and Gene Therapy Service, Great Ormond Street Hospital Trust for a Quality Assurance (QA) Manager. We are proud of being part of a well renowned national centre of excellence in the provision of specialist children's health care, currently delivering the widest range of specialist care of any children's hospital in the UK. The Cell and Gene Therapy Service manufactures life-saving therapies for paediatric patients under our MHRA licences. Our manufacturing facilities are licensed by the MHRA to allow us to function within the terms of our MIA(IMP) and MS licences.
The QA Manager will manage, monitor, and oversee the Quality Management System and Document Management System within the Cell and Gene Therapy Service. They will be responsible for maintaining adherence to GMP principles and regulatory requirements. This includes leading the implementation, improvement and management of Quality Management System as well as ensuring GMP documentation, quality records, qualification and validation documents are reviewed and approved in a timely manner. The QA Manager will also oversee the training programme, participate in audits and inspections, support document archiving activities. In addition, the postholder will lead a QA team providing QA support to internal activities, and commercial and academic partners.
We are therefore looking for a highly motivated individual who has a strong understanding of QA, GMP principles, and regulatory requirements. They will possess excellent communication, organisational, and leadership skills. The QA Manager will collaborate with various stakeholders, including the Head of Quality, QA Technical Lead, QC Manager, Head of Product Manufacturing, Production Manager, and Laboratory Manager and Validation Lead as well as external partners. This role is crucial in maintaining a culture of quality and excellence within the department, and the manager will play a pivotal role in ensuring that all Quality activities meet the highest standards of compliance and efficiency.
This is a fantastic opportunity to join our friendly and welcoming Quality team with its great diversity of skills and experience, we look forward to receiving your application.
We are committed to recruiting the best person for the job through a fair, open and consistent process that is free from bias and discrimination.
We are working towards becoming an anti-racist organisation. This means creating a workplace where every colleague feels seen, heard and valued, and where racism in any form has no place. Our anti-racism commitment is backed by action through our Anti-Racism Statement and action plan, developed in collaboration with our REACH staff network.
We actively challenge discrimination, dismantle barriers and embed equity across all aspects of our workforce, including recruitment, progression and development. All applicants will receive equal consideration regardless of race, ethnicity, nationality, religion or belief, sexual orientation, gender identity, age, disability, health condition or employment history.
We particularly welcome applications from ethnically diverse communities, people with disabilities or long-term health conditions, and LGBTQ+ community members. We are proud to be a Disability Confident Employer, a member of the Business Disability Forum, and a Stonewall Diversity Champion.
Our staff networks, including REACH, PRIDE, ENABLED and Women’s Networks, are active and executive supported. These employee-led networks play a vital role in shaping an inclusive culture at GOSH and are open to all colleagues.
Together, we are building a culture where inclusion is not optional - it is essential.
