Advanced Therapy Quality Assurance Assistant

Job Advert Skip to main content Cookies on NHS Jobs We've put some small files called cookies on your device to help us make improvements to our site. To improve our site we'd also like to use cookies which will send information to Google Analytics. You can read more about our cookies before you choose. Accept analytics cookies Do not accept analytics cookies Jobs Menu Sign in Create an account English Cymraeg Menu Close menu Search Sign in Create an account Display in Welsh (Cymraeg) Search Sign in Create an account Display in Welsh (Cymraeg) BETA Your feedback will help us to improve this service. Guy's and St Thomas' NHS Foundation Trust Advanced Therapy Quality Assurance Assistant The closing date is 01 November 2026 Apply for this job Job summary The Advanced Therapy Good Manufacturing Practice (GMP) Unit is co-located with the Clinical Research Facility (CRF) at Guy's Hospital on the 15th floor of the tower. The GMP Unit is purpose built for the manufacture of Advanced Therapy Medicinal Products such as somatic cell therapies, gene therapies and tissue engineered products for early-phase clinical trials. It is used for both commercial and non-commercial clients as well as departments within GSTFT and KCL to manufacture products related to trials undertaken in the CRF and at trial sites across the UK. The post holder will be personally responsible for supporting all QA activities. The unit itself holds a GMP licence for manufacturing of T-Reg cell therapies and CAR T-Cell gene therapies as well as new manufacturing processes. The post holder will also be responsible for organising systems and procedures to ensure compliance with current UK & EU legislation and Trust requirements. This will also include responsibility for following policies and standard operating procedures for manufacturing and quality assurance of the GMP Unit. The post holder will be responsible for the day to day QA queries from core staff and collaborators using the unit equipment and systems and ensuring that GMP compliance is maintained. Main duties of the job Operate within the PQS: Reviewing Planned Deviations, by assessing impact/risk on the manufacturing or testing process prior to its implementation. Report deviations through Quality deviations to line managers. You will undertake Preventive Actions and Change Controls to rectify exceptions and implement audit and inspection findings. Assist in the management and monitoring of QA and QC activities, ensuring that agreed quality standards of service are maintained. Enable preparation of quality data to be used in the certification of ATMPs. Undertake strategic judgements based upon specialist knowledge of the manufacturing process, operating within the boundaries of the PQS, such as: how to proceed during technical failures; PPM; Quality Control assessments; technical decisions; suitability of material for manufacture; analysis of anomalous results. Contribute to quality meetings internally and with collaborators, tracking the progress of open deviations and reporting on KPIs Understand how an electronic PQS operates and assist in the design and qualification in a new system. Have the ability to keep PQS logs current and escalate upcoming overdue items to appropriate personnel including the Heads of unit About us Guy's & St Thomas' NHS Foundation Trust (GSTFT) and King's College London (KCL) have formed a centre that has a strong focus on translational research taking advances in basic medical research out of the laboratory and into the clinical setting, forming a key part of the Department of Health's new strategy for research and development in the NHS. The Good Manufacturing Practice (GMP) Unit is co-located with the Clinical Research Facility (CRF) at Guy's Hospital. The GMP Unit is purpose built for the manufacture of somatic cell therapies, gene therapies and proteins for early-phase clinical trials. It is used by staff from different departments within GSTFT and KCL to manufacture products