Job summary
We are seeking an experienced and highly motivated Quality Manager to lead and support the safe transfer and establishment of Paediatric Bone Marrow/Stem Cell Transplant (BMT/HSCT) services from the Royal Marsden NHS Foundation Trust to the Evelina London Children's Hospital. This is a pivotal role responsible for ensuring that quality governance, regulatory compliance, and accreditation standards are embedded throughout the transition and ongoing service delivery.
The post holder will play a central role in achieving and maintaining compliance with the Human Tissue Authority (HTA) and Joint Accreditation Committee of ISCT and EBMT of the European Society for Blood and Marrow Transplantation (EBMT) (JACIE) standards, working closely with clinical, laboratory, and operational teams. This role requires strong leadership, detailed knowledge of regulatory frameworks, and the ability to coordinate complex service changes in a highly regulated clinical environment.
The post holder will be primarily based at the Evelina London site but will be expected to travel to the Royal Marsden Hospital - Sutton on occasion.
The Quality Manager is expected to act as the HTA designated individual (DI) following approval by the HTA.
Main duties of the job
- Lead the quality management aspects of the transfer of Paediatric BMT/HSCT services between hospital sites, ensuring continuity of care, patient safety, and regulatory compliance throughout the transition
- Develop and implement a comprehensive Quality Management System (QMS) aligned with HTA and JACIE standards
- Act as the key lead/DI for HTA licensing and inspections, including preparation, submission of documentation, and management of inspection outcomes
- To report incidents/serious adverse events and reactions both internally and to the HTA within expected time-frame and to investigate, provide follow-up reports and put in place and monitor corrective and preventative action plans
- Coordinate and support JACIE accreditation activities, including self-assessments, gap analyses, action plans, and accreditation visits
- Work collaboratively with clinical, laboratory, governance, and operational teams to ensure quality standards are embedded across all aspects of the Paediatric BMT/HSCT pathway
- Oversee document control processes, including SOP development, review, approval, and implementation across the service
- Lead and support audits, risk assessments, validations and produce corrective and preventive actions (CAPA)
- Provide advice and guidance on regulatory and accreditation requirements related to Paediatric BMT/HSCT services
- Monitor quality metrics, compliance indicators, and improvement plans, reporting progress to senior leadership and relevant governance forums
About us
Evelina London is part of Guy's and St Thomas' NHS Foundation Trust and we are responsible for providing services for women and children. With almost 4,000 dedicated staff, and led by an Executive Team and Board, we have significant devolved autonomy to focus operationally and strategically upon the needs of our patients. We also benefit from being part of a large and successful NHS foundation trust, whose values we share. We have an ambitious strategic development programme, with backing from Guy's and St Thomas'.
Every year, the number of children and young people Evelina London cares for, in our hospitals and in the community, continues to grow. We provide comprehensive health services from pre-conception, before birth, throughout childhood and into adult life. Evelina London is here for children, young people and women from London to South East England, and provides specialist care for families around the UK and across the world.
As the only NHS Trust in London with women's and specialist children's services on one site we have unique opportunities to provide excellent, high-quality, integrated care for mothers, babies and children. We operate through five clinical directorates: Children's Medicine and Neonatology; Children's Surgery, Theatres and Anaesthesia; Children's Cardio-respiratory and Intensive Care; Children's Community Services and Women's Services.
Job description
Job responsibilities
In collaboration with the transplant transition clinical lead to develop a quality management plan and oversight structure for the new service.
Lead the implementation, development and maintenance of the quality management system (QMS) which meets the needs of service users, and appropriate Regulatory and Accreditation bodies.
To act as the HTA designated individual (DI) following approval by the HTA.
Attend all meetings related to oversight of transplant aspects of service transition, prepare minutes for JACIE/transplant oversight group and assist to resolve any outstanding actions for completion.
Be responsible for ensuring Human Tissue Authority and JACIE compliance plus other regulatory requirements as necessary, for the planned Stem Cell Transplant/Cellular Therapy Programme in preparation for service transition, including the following:
- Map all aspects of the planned new service against JACIE and HTA standards and assemble evidence of compliance
- Prepare documents and checklists for inspection submissions
- Import and validation of standard operating procedures mapped to the new ECH service
- Setting up and managing the document control system
Assist and communicate with JACIE office/HTA/NHSE/ECH clinical leads for all matters related to transplant service transition.
Set up and manage third party and service level agreements across the transplant pathways with external providers, ensuring that these remain current and are reviewed by relevant legal and service staff. Agreements are required to be in place to support the transplant service at point of transition. e.g. cell processing and storage lab, Anthony Nolan donor service provision services, NHSBT ECP provision.
Ensure collection areas (apheresis and theatres) labs and clinical facilities meet regulatory requirements. To assist with setting critical parameters, and to monitor these and take action as necessary.
Assist as indicated by transplant or EPIC clinical leads to assist with ensuring transplant specific EPIC IT systems are fit for purpose and any updates or resolutions following transfer of service are actioned.
To work collaboratively with the processing facility to ensure smooth provision of service under the service level agreement.
To have oversight of the data management staff to ensure that data submission is complete and timely.
Job description
Job responsibilities
In collaboration with the transplant transition clinical lead to develop a quality management plan and oversight structure for the new service.
Lead the implementation, development and maintenance of the quality management system (QMS) which meets the needs of service users, and appropriate Regulatory and Accreditation bodies.
To act as the HTA designated individual (DI) following approval by the HTA.
Attend all meetings related to oversight of transplant aspects of service transition, prepare minutes for JACIE/transplant oversight group and assist to resolve any outstanding actions for completion.
Be responsible for ensuring Human Tissue Authority and JACIE compliance plus other regulatory requirements as necessary, for the planned Stem Cell Transplant/Cellular Therapy Programme in preparation for service transition, including the following:
- Map all aspects of the planned new service against JACIE and HTA standards and assemble evidence of compliance
- Prepare documents and checklists for inspection submissions
- Import and validation of standard operating procedures mapped to the new ECH service
- Setting up and managing the document control system
Assist and communicate with JACIE office/HTA/NHSE/ECH clinical leads for all matters related to transplant service transition.
Set up and manage third party and service level agreements across the transplant pathways with external providers, ensuring that these remain current and are reviewed by relevant legal and service staff. Agreements are required to be in place to support the transplant service at point of transition. e.g. cell processing and storage lab, Anthony Nolan donor service provision services, NHSBT ECP provision.
Ensure collection areas (apheresis and theatres) labs and clinical facilities meet regulatory requirements. To assist with setting critical parameters, and to monitor these and take action as necessary.
Assist as indicated by transplant or EPIC clinical leads to assist with ensuring transplant specific EPIC IT systems are fit for purpose and any updates or resolutions following transfer of service are actioned.
To work collaboratively with the processing facility to ensure smooth provision of service under the service level agreement.
To have oversight of the data management staff to ensure that data submission is complete and timely.
Person Specification
Qualifications and Education
Essential
- Educated to master's level or equivalent knowledge, skills and experience
- Post graduate quality management system qualification of equivalent experience
- Continuing professional development
Desirable
Previous Experience
Essential
- Extensive experience of quality management systems
- Staff management experience
- Experience of conducting audits and validations
- Experience of regulatory inspections
Desirable
- Experience of JACIE quality management systems and assessments
- Experience working under an HTA licence
Skills/knowledge/ability
Essential
- excellent interpersonal communication, negotiating skills with a track record of delivering performance targets
- knowledge of HTA and JACIE standards
- Ability to work along and as part of a team
- knowledge of audit processes/techniques
- knowledge of transplant and cellular therapy treatments
- knowledge of risk management, integrated governance and information governance
Person Specification
Qualifications and Education
Essential
- Educated to master's level or equivalent knowledge, skills and experience
- Post graduate quality management system qualification of equivalent experience
- Continuing professional development
Desirable
Previous Experience
Essential
- Extensive experience of quality management systems
- Staff management experience
- Experience of conducting audits and validations
- Experience of regulatory inspections
Desirable
- Experience of JACIE quality management systems and assessments
- Experience working under an HTA licence
Skills/knowledge/ability
Essential
- excellent interpersonal communication, negotiating skills with a track record of delivering performance targets
- knowledge of HTA and JACIE standards
- Ability to work along and as part of a team
- knowledge of audit processes/techniques
- knowledge of transplant and cellular therapy treatments
- knowledge of risk management, integrated governance and information governance
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Additional information
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
