Biobank and Cell Therapies Quality Manager
We have an exciting opportunity to provide a dual Quality Management role, in both the King’s Health Partners Cancer Biobank and Guy’s and St Thomas’ NHS Trust Cell Therapies.
The KHP Cancer Biobank supports the research of both academic and commercial groups and over the years has contributed to in excess of 335 publications, including articles in prestigious journals such as Nature, Cell, Cancer Discovery and Clinical Cancer Research). In recent years, the Biobank has expanded activities to include more solid and liquid cancers alongside different sample types.
Maintaining and demonstrating the quality of samples and data is paramount to the continuing success of the Cancer Biobank and critical for collaboration. The Biobank Quality Manager role is key to ensuring that the Cancer Biobank conducts its activities in accordance with defined regulations. However, we want to go beyond that and meet the more stringent requirements for the International standards for biobanking (ISO/FDIS 20387 Biotechnology – Biobanking). The Quality Manager is central to us attaining this standard, which will enable the Cancer Biobank to rank alongside other world-leaders.
In addition to the Biobank role, the Quality Manager would jointly support the exciting and rapidly expanding Cell Therapies department, creating synergy between these two regulated sectors.
Cellular therapies for the treatment of inflammatory disease, transplant and malignancy are already making significant advances 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 treatment of 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 already 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. The Quality Manager, will be responsible for all standard operating procedure (SOP) development and maintenance. They are essential to enable us to build our case as an IEC delivery centre and expand the treatments available to patients.
The post will be split 60:40 between Cancer Biobank and Cell Therapies.
Candidates are expected to have previous quality management experience and a working knowledge of UK human tissue and clinical trial regulatory requirements. The post will suit someone seeking to make a real change in two exciting and challenging environments, allowing 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 assist with the design, implementation and management of the KHP Cancer Biobank and GSTT Cell Therapies Quality Management Systems.
- To be responsive to changing priorities and an evolving regulatory environment.
- 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 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 Therapies 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
1. Degree, HND, NVQ 4 qualified or equivalent in relevant subject/ relevant formal traning, plus relevant experience in similar or related roles.
2. 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.
3. Evidence of an active commitment to professional development
4. Have in-depth knowledge of quality management practices, methods and procedures applicable to work area and to share best practice.
5. Proven quality management experience with a good understanding of management theory underpinning this.
6. Strong communication skills – orally and in writing.
7. Full working knowledge of Health & Safety regulations relating to laboratories.
8. Knowledge of the Human Tissue Act 2004 and Human Tissue Authority licence standards.
9. Experience of teaching and/or supervision of staff or students.
10. Flexible team-worker, being proactive and responsive to colleagues.
1. Expertise in IEC or bone marrow transplantation quality management.
2. Experience of Biobank quality management
3. Previous experience of working within a NHS environment.
This post is subject to Disclosure and Barring Service and Occupational Health clearance.