Advanced Therapy Quality Assurance Assistant

Guy's and St Thomas' NHS Foundation Trust; London; On-site; GBP 100,000 - 125,000; Full time

Job summary

A leading healthcare organization in London seeks a Quality Assurance professional for the Advanced Therapy GMP Unit. You will support QA activities for advanced therapy products, ensuring compliance with UK & EU regulations. Key duties include managing QA processes, participating in quality meetings, and ensuring quality standards are upheld across manufacturing. This role requires expertise in GMP and a commitment to organizational values.

Qualifications

• Proven experience in QA activities within a GMP environment.
• Understanding of UK & EU regulations and compliance.
• Ability to manage and evaluate quality control measures.

Responsibilities

• Organize systems and procedures for compliance with legislation.
• Manage and monitor QA and QC activities to ensure quality standards.
• Contribute to internal and external quality meetings.

Skills

Quality Assurance

Good Manufacturing Practice (GMP)

Risk assessment

Data analysis

Job description

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 manufacturing Advanced Therapy Medicinal Products such as somatic cell therapies, gene therapies, and tissue-engineered products for early-phase clinical trials. It serves both commercial and non-commercial clients, as well as departments within GSTFT and KCL, for products related to trials conducted in the CRF and at trial sites across the UK.

The post holder will be responsible for supporting all QA activities within the unit, which holds a GMP license for manufacturing T-Reg cell therapies, CAR T-cell gene therapies, and other new processes. Responsibilities include organizing systems and procedures to ensure compliance with UK & EU legislation and Trust requirements, following policies and SOPs for manufacturing and QA, and managing QA queries from staff and collaborators to maintain GMP compliance.

Key duties include:

1. Operating within the PQS framework: reviewing planned deviations, assessing impact/risk, reporting deviations, and implementing preventive actions and change controls based on audit and inspection findings.
2. Managing and monitoring QA and QC activities to ensure quality standards are maintained, and preparing quality data for ATMP certification.
3. Making strategic judgments related to manufacturing processes, technical failures, quality control assessments, and material suitability, within the boundaries of the PQS.
4. Contributing to internal and external quality meetings, tracking deviations, and reporting KPIs.
5. Understanding and assisting in the design, qualification, and current operation of electronic PQS systems, including escalating overdue items to appropriate personnel.

Guy’s & St Thomas’ NHS Foundation Trust (GSTFT) and King’s College London (KCL) have established a centre focused on translational research, advancing basic medical research into clinical applications as part of the Department of Health’s R&D strategy. The GMP Unit supports this mission by manufacturing cell and gene therapies and proteins for early-phase trials, used across various departments and trial sites.

Organisational Values

Our values define our culture, our actions, and our approach. It is essential to embody these values throughout your employment:

• Put patients first
• Take pride in what you do
• Respect others
• Strive to be the best
• Act with integrity

For more information or informal visits, contact:

Name: Sakina Gooljar
Job title: Head of Advanced Therapy Quality
Email: [e-mail]
Phone: [phone] ext 54880