Job summary
Advanced Therapy Medicinal Products (ATMPs), such as cellular therapies, are rapidly transforming the treatment landscape for cancer and other serious conditions. Guy's and St Thomas' NHS Foundation Trust (GSTT) has an ambitious and growing programme to deliver innovative ATMPs, including Immune Effector Cell (IEC) therapies, to our patients.
As the number of licensed cellular therapies expands, ensuring the Trust meets the highest national and international standards is essential. Achieving and maintaining JACIE-IEC accreditation is a priority for GSTT. This accreditation demonstrates that the Trust operates to rigorous, recognised standards of quality, safety and clinical excellence for advanced therapies.
The Assistant Quality Manager for ATMPs will play an important part in this work, supporting the Quality Manager for ATMPs to manage and continually strengthen the Quality Management System for the IEC programme. The role will contribute directly to preparing for JACIE-IEC accreditation, ensuring robust regulatory compliance across collection, processing, and clinical services, and supporting the wider development and delivery of GSTT's advanced therapy programme -- ensuring patients benefit from safe, cutting-edge treatments now and in the future.
Main duties of the job
Quality Management & Compliance
Maintain and improve the QMS for cellular therapies in line with JACIE-IEC, HTA, and other regulatory standards.
Support internal/external audits and inspections, and accreditation processes.
Manage SOPs, policies, and document control.
Support incident and deviation management, CAPA plans, and risk assessments.
Help align the QMS with other units (e.g. GMP manufacturing facilities).
Project Support
Assist with developing and expanding the IEC Programme.
Support service improvement projects and manage project administration.
Contribute to business cases, grant applications, and procurement processes.
Training & Education
Support training programmes to embed a quality culture.
Deliver training sessions and maintain training records for staff involved in the IEC programme.
Data & Reporting
Maintain accurate records and databases for quality and clinical activities.
Generate reports for internal stakeholders and national/international registries.
General
Deputise for the Quality Manager for ATMPs as needed.
Work collaboratively across departments and with key stakeholders.
Comply with all relevant policies on confidentiality, data protection, health and safety and equality and diversity
About us
Guy's and St Thomas' NHS Foundation Trust comprises five of the UK's best known hospitals - Guy's, St Thomas', Evelina London Children's Hospital, Royal Brompton and Harefield - as well as community services in Lambeth and Southwark, all with a long history of high quality care, clinical excellence, research and innovation.
We are among the UK's busiest, most successful foundation trusts. We provide specialist care for patients including heart and lung, cancer and renal services as well as a full range of local hospital and community services for people in Lambeth and Southwark.
We have a long tradition of clinical and scientific achievement and - as part of King's Health Partners - we are one of England's eight academic health sciences centres, bringing together world-class clinical services, teaching and research. We have one of the National Institute for Health Research's biomedical research centres, established with King's College London in 2007, as well as dedicated clinical research facilities.
Job description
Job responsibilities
Please refer to the attached Job Description and Person Specification for a full list of role requirements and main responsibilities.
Job description
Job responsibilities
Please refer to the attached Job Description and Person Specification for a full list of role requirements and main responsibilities.
Person Specification
Education / Qualifications
Essential
- Educated to Master's degree level in a relevant field, or equivalent experience or qualification in Quality Assurance/Management.
- Knowledge of NHS or healthcare systems and their regulatory environment.
- Understanding of current regulation/legislation, and quality considerations of cellular therapies, or related therapies (e.g. HSCT/BMT), including FACT-JACIE and HTA Human Application
- Understanding of a range of Quality Improvement (QI) methodologies.
Desirable
- Knowledge of clinical aspects of Immune Effector Cell therapies, or related cellular therapies, such as Haematopoietic Stem Cell Transplantation.
- Relevant training or experience in research methodologies and clinical audit.
- Understanding and experience of Q-Pulse administration and governance processes, including incident management and risk assessment.
Experience
Essential
- Experience in a regulated healthcare setting, with a focus on quality management
- Experience in supporting internal and external audits, including preparation and follow-up actions, in a service or programme of work.
- Involvement in developing and implementing policies and procedures that support service development.
Desirable
- Experience in monitoring and management of budgets
Skills / Knowledge / Abilities
Essential
- Strong organisational skills with the ability to prioritise and manage workload effectively
- Excellent communication skills, capable of engaging with staff at all levels and delivering highly complex information succinctly and effectively.
- Ability to encourage collaborative working amongst a wide variety of stakeholders, both internal and external.
- Proficient in IT systems, including MS Office Suite, EPIC and Q-Pulse.
Person Specification
Education / Qualifications
Essential
- Educated to Master's degree level in a relevant field, or equivalent experience or qualification in Quality Assurance/Management.
- Knowledge of NHS or healthcare systems and their regulatory environment.
- Understanding of current regulation/legislation, and quality considerations of cellular therapies, or related therapies (e.g. HSCT/BMT), including FACT-JACIE and HTA Human Application
- Understanding of a range of Quality Improvement (QI) methodologies.
Desirable
- Knowledge of clinical aspects of Immune Effector Cell therapies, or related cellular therapies, such as Haematopoietic Stem Cell Transplantation.
- Relevant training or experience in research methodologies and clinical audit.
- Understanding and experience of Q-Pulse administration and governance processes, including incident management and risk assessment.
Experience
Essential
- Experience in a regulated healthcare setting, with a focus on quality management
- Experience in supporting internal and external audits, including preparation and follow-up actions, in a service or programme of work.
- Involvement in developing and implementing policies and procedures that support service development.
Desirable
- Experience in monitoring and management of budgets
Skills / Knowledge / Abilities
Essential
- Strong organisational skills with the ability to prioritise and manage workload effectively
- Excellent communication skills, capable of engaging with staff at all levels and delivering highly complex information succinctly and effectively.
- Ability to encourage collaborative working amongst a wide variety of stakeholders, both internal and external.
- Proficient in IT systems, including MS Office Suite, EPIC and Q-Pulse.
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.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Additional information
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.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
