Job overview
An exciting opportunity has arisen for a Quality Manager within the Haematopoietic Stem Cell Transplant and Cellular Therapy Programme at the Royal Marsden Hospital.
The programme operates within an established Quality Management System, providing specialist quality support for the Transplant and Cellular Therapy programme. Applications are invited from experienced, enthusiastic, highly motivated and organised individuals to maintain and develop the quality management system to meet the requirements of the current regulatory and accreditation bodies, such as JACIE and HTA, while continually promoting an ethos of quality to all staff within the programme.
Applicants must have proven quality management experience and hold MSC/FIBMS or similar level qualification. Ideally applicants should have direct experience in the field of transplantation, or in a related area. A working knowledge of HTA and JACIE standards and experience of inspections and the use of electronic document management systems are important requirements.
Main duties of the job
Assist the Lead QM in ensuring Human Tissue Authority and JACIE compliance of clinical and collection facilities as per HTA and JACIE standards plus other regulatory requirements as necessary including the following:
1. Use of the QMS for document control and equipment maintenance
2. Change control
3. Incident investigation & corrective and preventative actions (CAPA)
4. Internal audits
5. Validations
6. Risk assessment
7. External qualification and audits as necessary
8. Developing and reviewing related documentation
Detailed job description and main responsibilities
9. Participate in the development and maintenance of the quality management system (QMS) which meets the needs of service users, and appropriate Regulatory and Accreditation bodies.
10. Promote continuous quality improvements and support the service with their implementation and review.
11. Assist in the management of document control procedures – writing, reviewing, distribution and archiving of documents using Q-Pulse. Ensure there are systems to maintain current Q-Pulse user registers. Actively support document owners in review of documents. Ensure that all staff across the programmes are made aware of updates and use of the system.
12. Engage with stakeholders to ensure that new pathways and processes are fit for purpose and that staff are actively engaged and supportive.
Person specification
Education
Essential criteria
13. Post-Graduate qualification/training in Quality Management or equivalent level of experience of working with quality management
Desirable criteria
14. Educated to master’s level or equivalent in life sciences or related discipline
Experience
Essential criteria
15. Experience of quality management
16. Experience of conducting audits and Validations
17. Experience of writing standing operating Procedures
18. Experience of regulatory inspections
19. Experience of design and delivery of training
Desirable criteria
20. Experience working at AfC Band 7 (or equivalent) level
21. Experience of JACIE quality management systems and assessments
22. Experience of working under a human application HTA licence
23. Health Service experience
24. Experience of working in the field of haematology or transplantation
Skills
Essential criteria
25. Ability to communicate clearly both orally and in writing to all levels
26. Knowledge of risk management, integrated governance and information governance
Desirable criteria
27. Knowledge of transplant and cellular therapy pathways and treatments
Other
Essential criteria
28. Able to work independently with management oversight
The Royal Marsden values diversity and is committed to the recruitment and retention of underrepresented minority groups. We particularly welcome applications from Black, Asian and minority ethnic candidates, LGBTQ+ candidates and candidates with disabilities.
As a Disability Confident Employer, we are working to create a workplace that enables all staff to reach their full potential. We are committed to this because we know that greater diversity and inclusion will lead to an even greater positive impact for the people we serve.
Due to the high volumes of applications we receive, we reserve the right to close any adverts before the published closing date once we have received a sufficient number of applications. We advise you to submit your application as early as possible to prevent disappointment.
Flu Vaccination – What We Expect of our Staff
At The Royal Marsden we have an immune compromised patient population who we must protect as much as we can against the flu virus. Each year, seasonal flu affects thousands of people in the UK. Occurring mainly in winter, it is an infectious respiratory disease capable of producing symptoms ranging from those similar to a common cold, through to very severe or even fatal disease.
The wellbeing of our staff and patients is of the upmost importance to us, and it is the expectation of The Royal Marsden that all patient-facing staff have an annual flu vaccination, provided free of charge by the Trust.
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