An exciting opportunity has arisen for a Quality Officer for the Cellular Therapy Programme at The Royal Marsden NHS Foundation Trust.
Commissioned products and clinical trials involving novel cell therapies are transforming care for patients and the trust is committed to supporting pioneering research in this area. Use of these evolving therapies must meet demanding standards set by regulatory bodies to ensure patient safety and full traceability of tissues and cells. The post holder will be responsible for compliance of the delivery of commissioned Cell Therapy products and advanced therapeutic investigational medicinal products (ATIMPS) within the regulatory requirements of the Human Tissue Authority and JACIE as well as clinical trial sponsors. This will include the following elements of the quality management system:
• Use of the document control system
• Change control
• Incident investigation & corrective and preventative actions (CAPA)
• Internal audits
• Validations
• Risk assessment
• External qualification and audits as necessary
• Review of related documentation
Commissioned products and clinical trials involving novel cell therapies are transforming care for patients and the trust is committed to supporting pioneering research in this area. Use of these evolving therapies must meet demanding standards set by regulatory bodies to ensure patient safety and full traceability of tissues and cells. The post holder will be responsible for compliance of the delivery of commissioned Cell Therapy products and advanced therapeutic investigational medicinal products (ATIMPS) within the regulatory requirements of the Human Tissue Authority and JACIE as well as clinical trial sponsors.
The Royal Marsden NHS Foundation Trust is a world-leading cancer centre. Our role is to offer our patients the best cancer care available anywhere in the world, and to continue to make a global contribution to finding better ways of diagnosing and treating cancer. We employ over 4,500 staff in a diverse range of careers including nursing, medical, science, radiography, pharmacy, occupational therapy, finance and administrative services. We have two hospitals – one in Chelsea, London, and one in Sutton, Surrey – as well as a Medical Daycare Unit in Kingston Hospital.
At The Royal Marsden, we deal with cancer every day, so we understand how valuable life is. When people entrust their lives to us, they have the right to demand the very best. That's why the pursuit of excellence lies at the heart of everything we do.
At the heart of the hospital is our dedicated team. We offer a stimulating and dynamic working environment, a wide range of staff benefits, learning and development opportunities and clear career pathways. There are opportunities to work flexibly across a range of areas and specialities and we welcome flexible working requests from point of hire to support employees work life balance. We are looking for employees who aspire to excellence, share our values and can play a crucial role in our on-going achievements.
For further information on this role, please see the attached detailed Job Description and Person Specification:
• To ensure along with the DI that commissioned cellular therapy products and ATIMPs meet regulatory requirements
• To provide support and expert advice to clinical research teams in meeting Human Tissue Authority (HTA) and JACIE requirements
• To work under the direction of and to communicate regularly with the Trust’s HTA Designated Individual (DI) for the Human Application licence.
• To keep up-to-date on legislative requirements and make recommendations for subsequent operational changes
• To ensure full traceability of tissues and cells from collection to infusion or disposal along with the wider quality team.
This advert closes on Tuesday 11 Feb 2025
Proud member of the Disability Confident employer scheme
Disability Confident
About Disability Confident
A Disability Confident employer will generally offer an interview to any applicant that declares they have a disability and meets the minimum criteria for the job as defined by the employer. It is important to note that in certain recruitment situations such as high-volume, seasonal and high-peak times, the employer may wish to limit the overall numbers of interviews offered to both disabled people and non-disabled people. For more details please go to Disability Confident .