Quality Assurance Technical Lead - Cell & Gene Therapy Services

Job summary

Quality Assurance Technical Lead - Gene and Cell Therapy

An excellent opportunity has presented itself at Great Ormond Street Hospital Trust, Zayed Centre for Research into Rare Disease (ZCR) for a Quality Assurance Technical Lead in our Gene and Cell Therapy department. 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 Gene and Cell Therapy department manufactures life-saving therapies for paediatric patients under both our MHRA and HTA licences. We are expecting to soon manufacture within our new state of the art, purpose-built facility (ZCR), comprising of seven cGMP compliant laboratories and support services.

Our manufacturing facilities are licensed by the MHRA to allow us to function within the terms of our MIA(IMP) and Specials licenses.

Main duties of the job

The post holder will provide specialist technical expertise to the GOSH Qualified Person (QP) by pre-reviewing against challenging target release dates the batch manufacturing documentation for all ATIMPs manufactured by the GCT teams, identifying any issues/deviations and resolving these where possible, and where it is not possible to close them, to review the quality risk and implication to the batch with the QP as well as ensuring these are reflected in the Pharmaceutical Quality Management System. The QA Technical Lead will assist and support the QP in duties delegated to them by the QP and confirm compliance with cGMP, the GOSH MIA(IMP) and Specials licences, the IMPD, the Product Specification File and other current regulatory requirements before the review for batch certification by the QP.

This post will also provide great opportunity for the postholder to work with the Senior Manufacturing Lead Scientists to assess and kick-start new projects and support training as required of new staff recruited to work on new projects whilst ensuring compliance with agreed standards and ensuring rapid turnaround.

We are therefore looking for a highly motivated individual who has a broad skillset and excellent oral and written communication skills. An individual who has a number of years of experience working in a GMP and QA environment is therefore essential for this post in order to provide the required support and guidance to our Production and QA departments and the QP.

About us

GOSH is committed to recruiting the best person for the job, based solely on their ability and individual merit as measured against the criteria for the role; through a process that is fair, open, consistent and free from bias and discrimination.

We are committed to being a diverse and inclusive employer and foster a culture where all staff are valued, respected and acknowledged. All applicants will receive consideration for employment without regard to race, colour, national origin, religion, sexual orientation, gender, gender identity, age, disability status or length of time spent unemployed.We particularly welcome applications from BAME communities, people with disabilities and/or long-term health conditions and LGBT+ community members.We have policies and procedures in place to ensure that all applicants and employees are treated fairly and consistently. We are proud to be accredited as a Disability Confident Employer, a member of Business Disability Forum and a Stonewall Diversity Champion.We have active and Executive supported BAME, LGBT+ and Allies, Disability and Long-Term Health Conditions and Women's staff networks. Staff networks are employee-led groups formed around interests, issues and a common bond or background. Staff network members create a positive and inclusive work environment at Great Ormond Street Hospital by actively contributing to the Trust's mission, values and efforts specific to inclusion. All of our staff networks are open to any employee.