Assistant Quality Manager - Advanced Therapies Medicinal Products

Job overview

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

Detailed job description and main responsibilities

Please refer to the attached Job Description and Person Specification for a full list of role requirements and main responsibilities.