Great Ormond Street Hospital for Children NHS Foundation Trust
Quality Assurance Manager - Cell & Gene Therapy Service
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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.
Responsibilities
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 the Quality Management System.
- Ensuring GMP documentation, quality records, qualification, and validation documents are reviewed and approved in a timely manner.
- Overseeing the training programme.
- Participating in audits and inspections.
- Supporting document archiving activities.
- Leading a QA team providing QA support to internal activities, and commercial and academic partners.
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Requirements
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 ability to collaborate with various stakeholders, including the Head of Quality, QA Technical Lead, QC Manager, Head of Product Manufacturing, Production Manager, Laboratory Manager, and Validation Lead as well as external partners.
About Us
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.
We are a friendly and welcoming Quality team with its great diversity of skills and experience, and we look forward to receiving your application.
Our Commitment
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.
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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.
Contact Information
For further details / informal visits contact:
- Name: Shok Ping Lim
- Job title: Head of Quality
- Email address: shokping.lim@gosh.nhs.uk
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