Quality Manager

5 days ago

Sutton, United Kingdom The Royal Marsden NHS Foundation Trust Full time

Job summary

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 system change control incident investigation & corrective and preventative actions (CAPA) internal audits validations external qualification and audits as necessary developing and reviewing related documentation

For more information, please contact Elaine Tomlins- Nurse Consultant

Main duties of the job

- Be responsible for ensuring Human Tissue Authority and JACIE complianceplus 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), labsand clinical facilities meet regulatory requirements. To assist with settingcritical parameters, and to monitor these and take action as necessary.

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

About us

The Royal Marsden NHS Foundation Trust is a world-leading cancer centre. Our role is to offer our patients the best cancer care available anywhere in the world, and to continue to make a global contribution to finding better ways of diagnosing and treating cancer. We employ over 4,500 staff in a diverse range of careers including nursing, medical, science, radiography, pharmacy, occupational therapy, finance and administrative services. We have two hospitals - one in Chelsea, London, and one in Sutton, Surrey - as well as a Medical Daycare Unit in Kingston Hospital.

At The Royal Marsden, we deal with cancer every day, so we understand how valuable life is. When people entrust their lives to us, they have the right to demand the very best. That's why the pursuit of excellence lies at the heart of everything we do.

At the heart of the hospital is our dedicated team. We offer a stimulating and dynamic working environment, a wide range of staff benefits, learning and development opportunities and clear career pathways. There are opportunities to work flexibly across a range of areas and specialities and we welcome flexible working requests from point of hire to support employees work life balance. We are looking for employees who aspire to excellence, share our values and can play a crucial role in our on-going achievements.

Job description

Job responsibilities

For further information on this role, please see the attached detailed Job Description and Person Specification :

Provide leadership and direct line management for the deputy qualitymanagers 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 qualitymanagement system (QMS) which meets the needs of service users, andappropriate 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 fitfor 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

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

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

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

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

Ability to work on both sites of the Trust Able to work independently with management oversight

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