Research Nurse

4 days ago

Sutton, United Kingdom The Royal Marsden Full time

Job overview

An exciting opportunity has arisen for a Quality Manager – Haematopoietic Stem Cell Transplantation/Cellular Therapy Programme, working on the Sutton site with occasional work at Chelsea. 

The major focus of the role will be to hold responsibility for ensuring Human Tissue Authority and JACIE compliance plus other regulatory requirements as necessary, for the Stem Cell Transplant and Cellular Therapy Programmes, including the following:

using the document control systemchange controlincident investigation & corrective and preventative actions (CAPA)internal auditsvalidationsexternal qualification and audits as necessarydeveloping and reviewing related documentation

Main duties of the job

- Be responsible for ensuring Human Tissue Authority and JACIE compliance plus other regulatory requirements as necessary, for the Stem Cell Transplant and Cellular Therapy Programmes

- Develop, maintain and monitor the Quality Management System

- Lead JACIE/HTA quality meetings and take responsibility for overseeing the minuting of the meetings and chasing actions

- Ensure collection areas (apheresis and theatres - Sutton and Chelsea), labs 
and clinical facilities meet regulatory requirements. To assist with setting 
critical parameters, and to monitor these and take action as necessary.

- Produce a quarterly report in a timely manner of pathway activity and to 
perform an annual audit of the effectiveness of the QMS

Detailed job description and main responsibilities

·Provide leadership and direct line management for the deputy quality 
managers in HSCT/Cell Therapy, data managers and admin support). Ensure cross-cover provided to cover annual leave and sickness.

·To define and agree job descriptions of managed staff, take responsibility for recruitment and perform appraisals 

·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.

·Lead and promote continuous quality improvements and support the service with their implementation and review.

• Engage with stakeholders to ensure that new pathways and processes are fit 
for purpose and that staff are actively engaged and supportive.

• Book suitable meeting venues, prepare agendas and type minutes and action plans as required. Arrange accommodation for inspectors as required.

Person specification

Qualifications

Desirable criteria

Educated to master’s level or equivalent Post-Graduate Quality Management System qualification or equivalent level of experience of working with quality management Clinical qualification

Experience

Essential criteria

Experience of quality management systems Staff management experience Experience of conducting audits and validations Development of standing operating procedures Experience of regulatory inspections Experience of design and delivery of training

Desirable criteria

Experience of JACIE quality management systems and assessments Experience of working under an HTA licence Health Service experience Experience of working in the field of haematology or transplantation Experience of validation of IT systems

Skills

Essential criteria

Ability to work with consistently high levels of attention to detail Knowledge of JACIE and HTA inspection processes Knowledge of audit processes/techniques Knowledge of transplant and cellular therapy treatments Knowledge of risk management, integrated governance and information governance

Other requirements

Essential criteria

Ability to work on both sites of the Trust 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.

Employer certification / accreditation badges

Applicant requirements

The postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.

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