South Wales Blood and Marrow Transplant Programme

Senior Quality Manager - Band 8a

Applications are invited for an enthusiastic and motivated Senior Quality Manager to join the South Wales Blood and Marrow Transplant (SWBMT) Programme to support the programme in maintaining the requirements for JACIE accreditation and the safe delivery of exciting new cellular therapies, including CAR-T therapy.

The SWBMT Programme is an accredited service which incorporates adult, teenage/young adult and paediatric services on the University Hospital of Wales site and an adult service at Singleton Hospital in Swansea. The catchment area accounts for a large proportion of the Welsh population and spans six Welsh Local Health Boards, encompassing the South Wales Cancer Network. The clinical programme is supported by a collection, processing and storage facility on the UHW site and holds an HTA license. The SWBMT Programme Director is assisted by directors of the clinical, collection and processing facilities plus a quality and data management team.

The ability to speak Welsh is desirable for this post English and/or Welsh speakers are equally welcome to apply.

Main duties of the job

The Senior Quality Manager is responsible for ensuring that SWBMT Programme activities meet all relevant regulatory and quality standards. The post holder will implement and lead on the management of the Quality Management System to demonstrate the compliance status within the programme and will be responsible for highlighting any resource issues in the service. The post holder will be managerially accountable for administrative staff employed in the quality and data management teams, and will need to demonstrate exceptional leadership, communication and negotiation skills when interacting with individuals at all levels of the organisation and with external stakeholders.

The Senior Quality Manager is also accountable for risk and adverse event management within the SWBMT Programme, and will be required to work across different disciplines to strategically manage the Quality Management System to ensure that it remains robust and effective. Excellent communication skills and the ability to work as part of a multi-disciplinary team will be essential in this role.

The successful candidate must be capable of working under pressure to meet deadlines, and possess excellent organisational and problem solving skills. They must have the ability to confidently engage with colleagues at all levels of the organisation. The post holder will be required to work autonomously to drive forward their own programme of work and will need to use innovation to overcome challenges.

About us

Cardiff and Vale University Health Board is one of the largest Integrated Health Boards in the UK, employing over 15,000 staff, providing over 100 specialist services. Working across 6 hospital sites, we have a diverse range of career opportunities to offer. Serving around 500,000 people living in Cardiff and the Vale of Glamorgan, we are focussed on the health and care needs of our local population whilst working with our partners to develop regional services.

Our mission is Caring for People, Keeping People Well, and our vision is that every person's chance of leading a healthy life should be equal. As an organisation we are unashamedly ambitious for our population's health, rising to the challenges of today and tomorrow through our 10-year strategy, Shaping our Future Wellbeing. We are contributing to a healthier Wales with great emphasis placed on innovation and improvement, learning from around the world and leading the way in clinical research. Partnership working is strong at Cardiff and Vale, and we work closely with our staff and our community.

Applicants are invited to apply in Welsh, any application submitted in Welsh will not be treated less favourably than an application made in English.

Job description

Job responsibilities

You will be able to find a full Job description and Person Specification attached within the supporting documents or please click Apply now to view in Trac.

This is an exciting time to join the SWBMT Programme and is an excellent opportunity for you to further your career, so if you feel that you have the knowledge and experience required to undertake this challenging role then we would like to hear from you.

Person Specification

Qualifications

Essential

• Masters Degree in a relevant related discipline to include Life Sciences, IT, Business, Nursing or Medical, or extensive equivalent experience.
• Improvement qualification such as Lean, Six Sigma etc, obtained through Yellow Belt course or equivalent.
• Evidence of Continuous Professional Development (CPD).

Desirable

• Diploma level managerial qualification.
• Quality Management qualification or relevant experience.
• Current discipline-appropriate professional registration.

Experience

Essential

• Experience of Quality Management issues and Change Control.
• Previous audit experience.
• Extensive experience of development and delivery of education and training strategies/programmes.
• Competent in the use of relevant software packages e.g. Microsoft Office.
• Line management experience.

Desirable

• Laboratory or Clinical management experience, preferably in a Haematology / Transfusion discipline.
• Experience of external inspection/audit.
• Experience of Customer Care and audit.
• Project Management experience.

Special Knowledge

Essential

• Expert knowledge of Quality Management Systems, incl. ISO & BSI.
• Advanced knowledge of Regulatory compliance issues applicable to clinical and laboratory areas, incl. GxP systems.
• Working knowledge of HTA / JACIE / MHRA standards.
• ISO 9000+ requirements.
• Thorough understanding of document control.
• Expert knowledge of Change Control and Validation Systems.
• Expert knowledge of Root Cause Analysis and other quality management tools and techniques.

Desirable

• Finance, budget holding and resource management.
• Database Management systems.
• Risk, Process & Change Management. Health and Safety.
• UK guidelines for the Blood Transfusion Services in the UK (Red Book).
• Working knowledge of BSQR and MDR standards.
• Knowledge of Council of Europe Guidelines.
• Rules and Guidelines for Pharmaceutical Manufacturers and Distributors (Orange Book).

Personal Qualities

Essential

• Professional approach to duties.
• Excellent leadership qualities.
• Excellent communication skills.
• Flexible/adaptable to change.
• Self-motivated and dynamic approach.
• Ability to develop strong working relationships, internally and externally.
• Commitment to continuing professional development of staff and self.
• Drive for results: Displays a strong commitment to delivering improvements in quality and achieving positive outcomes for service users.
• Ability to work calmly under pressure and maintain high standards of work.

Desirable

• Welsh speaker.

Other

Essential

• Ability to travel between sites in a timely manner.
• Able to work flexibly to meet the needs of the service.
• Excellent organisational & interpersonal skills.
• Able to motivate staff.
• Able to deliver to specified deadlines.
• Able to work flexibly to accommodate user & imposed demands of the SWBMT Programme.
• Able to adapt and implement new changes to Laboratory Medicine.
• Able to motivate and implement quality improvement across Laboratory Medicine.
• Strong sense of personal commitment and integrity to Cardiff & Vale UHB.

Employer details

Employer name

Cardiff and Vale University Health Board

Address

University Hospital of Wales

Cardiff

CF14 4XW

Any attachments will be accessible after you click to apply.

001-AC328-0924