Biobank and Cell Therapies Quality Manager
This post will have a dual Quality Management role, supporting both the King’s Health Partners Cancer Biobank and Guy’s and St Thomas’ NHS Trust Cell Therapies.
The KHP Cancer Biobank is accessed by academic and commercial research groups under strict governance processes and contributed to a significant number of research outputs (in excess of 335 publications which has included articles in high impact publications such as Nature, Cell, Cancer Discovery, J Natl Cancer Inst, Nature Commun and Clin Cancer Res). In recent years, the Biobank has expanded tumour-associated collections to include both additional solid and liquid cancers alongside increasing sample types.
Maintaining and evidencing the quality of samples and data is paramount to the continuing success of the Cancer Biobank and critical to collaboration with commercial companies.
The Biobank Quality Manager role is key to ensuring that the Cancer Biobank conducts its activities in accordance with defined regulations and Human Tissue Authority (HTA) licensing standards. The introduction of new International standards for biobanking (ISO/FDIS 20387 Biotechnology – Biobanking) will enable the Cancer Biobank to rank alongside other world-leading cancer biobanks and attract commercial and high-profile academic requests for sample access.
In addition to the Biobank role, the Quality Manager would jointly support Cell Therapies, creating synergy between these two regulated sectors.
Cellular therapies for the treatment of inflammatory disease, transplant and malignancy are progressively advancing at the clinical edge of translational drug development. In the cancer field, chimeric antigen receptor (CAR) gene modified autologous cell therapies have EMA licences and NHS England approval for focused clinical indications in some leukaemias and lymphoma. These licenses have driven rapid national coordination to create centres with accreditation to deliver CAR T cells. These CAR T cell centres require Joint Accreditation Committee ISCT-Europe & EBMT (JACIE) IEC accreditation.
Guy’s and St Thomas’ NHS Foundation Trust (GSTFT) is not JACIE accredited, but we are a major solid tumour cancer centre, an early phase MHRA phase 1 accredited site and a centre that is leading on the delivery of IEC therapies for non-cancer indications. In the cancer space we currently have one academic and four commercial IEC trials recruiting in solid tumours and we have four further trials in active set up.
It is a clear goal of GSTFT to develop the IEC service and be ready to deliver licensed IEC therapies when they come online for solid tumour and non-malignant indications. To do this we need to be JACIE-IEC accredited and central to this is the need to have thorough oversight of quality. A quality manager, who will be responsible for all standard operating procedure (SOP) development and maintenance, is essential to enable us to build our case as an IEC delivery centre.
The post will be split 60:40 between Cancer Biobank and Cell Therapies. An experienced Quality Manager is required to implement procedures that will allow both groups to reach their true potential.
The post is funded by Guy’s Cancer for 12 months and has a strong rationale for longer-term funding.
This post will be offered on a fixed-term contract for 12 months
This is a full-time post - 100% full time equivalent
- To provide recognised specialist expertise for a specialised service, where the primary focus will be on operating as advisors or service providers, supporting research activity. There will be a need for liaison with service users and the coordination of activities across a number of sections of a School and NHS Trust.
- To be responsive to changing priorities and an evolving environment/context, maximising the efficiency of the quality management support being provided
- To forge relationships with colleagues in the School, Faculty, University and NHS Trust in order to contribute to process development and adoption of best practice
- To foster a stimulating, innovative and inclusive cultural environment across the School and NHS Trust enabling students and staff to thrive and develop, ensuring that processes and policies are visible, accessible and transparent
- To provide advice and guidance and, where appropriate, training on policies, processes and where required, source information and support for colleagues to facilitate their work.
- To communicate information clearly and precisely. The clarification of matters of a non-routine nature will be a substantial part of the job.
- To actively engage in Continuing Professional Development and training initiatives.
The post holder will report to the KHP Cancer Biobank Manager and Cell Therpies Program Lead.
The above list of responsibilities may not be exhaustive, and the post holder will be required to undertake such tasks and responsibilities as may reasonably be expected within the scope and grading of the post.
Skills, knowledge, and experience
- Degree, HND, NVQ 4 qualified or equivalent in relevant subject/ relevant formal traning, plus relevant experience in similar or related roles. OR
- Significant vocational experience, demonstrating development through involvement in a series of progressively more demanding relevant work/roles, and the acquisition of appropriate professional or specialist knowledge.
- Evidence of an active commitment to professional development
- Have in-depth knowledge of quality management practices, methods and procedures applicable to work area and to share best practice.
- Proven quality management experience with a good understanding of management theory underpinning this.
- Strong communication skills – orally and in writing.
- Full working knowledge of Health & Safety regulations relating to laboratories.
- Knowledge of the Human Tissue Act 2004 and Human Tissue Authority licence standards.
- Experience of teaching and/or supervision of staff or students.
- Flexible team-worker, being proactive and responsive to colleagues.
- Expertise in IEC or bone marrow transplantation quality management.
- Experience of Biobank quality management
- Previous experience of working within a NHS environment.
This post is subject to Disclosure and Barring Service and Occupational Health clearance.