Go back Great Ormond Street Hospital for Children NHS Foundation Trust
Quality Assurance Manager – Cell & Gene Therapy Service
The closing date is 05 August 2026
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.
Main duties of the job
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.
About us
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.
Job responsibilities
The full job description provides an overview of the key tasks and responsibilities of the role, and the person specification outlines the qualifications, skills, experience, and knowledge required. For both documents please view the attachment/s below.
Person Specification
- BSc or equivalent in relevant scientific discipline
- Postgraduate qualification in Pharmaceutical Quality Assurance or equivalent experience
- Training in QMS, QA or relevant experience
- BSc or equivalent in relevant scientific discipline
GOSH Culture and Values
- Our Always values
Experience/Knowledge
- Thorough understanding of Good Manufacturing Practice and Good Clinical Practice
- Thorough understanding of regulatory requirements pertaining to ATMPs and sterile products
- Proven experience of training and supervising
- Experience of working in a licensed facility holding an MIA(IMP)
- Proven experience of working in a QA environment
- Proven experience in developing, implementing and improving QMS
- Proven experience of QMS management and monitoring
- Proven experience of Document Control System management
- Proven experience of change, deviation, risk and CAPA management
- Proven experience of leading of deviation investigation and root cause analysis
- Proven experience of supplier assessment and approval
- Proven experience in qualification and validation activities
- Proven experience of training programme management in a GMP facility
- IT competent (Word, Excel and Power Point)
- Experience of working under a Specials licence
- Experience of using Ideagen Quality Management System
Skills/Abilities
- Ability to work on assigned projects with limited supervision
- Strong communication skills, both verbal and written
- Good attention to detail and accuracy
- Strong organisational skills and demonstrated ability to prioritise and meet deadlines
- Strong leadership skills
- Ability to work independently and as part of a team
- Demonstrated critical thinking and good problem-solving skills
- Demonstrated ability to teach and supervise
- Strong computer and scientific skills
- Demonstrated ability to self-motivate and a positive attitude
- Project management
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Great Ormond Street Hospital for Children NHS Foundation Trust
Address
Zayed Centre for Research, Great Ormond Street Hospital for Children
£66,274 to £73,496 a yearper annum inclusive
Contract
Permanent
Working pattern
Full-time
Reference number
271-RI-8136288
Job locations
Zayed Centre for Research, Great Ormond Street Hospital for Children
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