Job summary
Quality is an independent NHSBT Corporate function with the core purpose of assuring patient and donor safety. We work with the organisation, and in this role, Clinical Services, to ensure that we fully comply with all the relevant Quality Standards and Regulatory requirements to deliver the best service to patients, donors, customers, and other stakeholders, while ensuring a proportionate approach and enabling the organisation to achieve its strategic goals. This objective is fully aligned to our organisational mission of Saving and Improving Lives; and with our core values and behaviours.
The role of National QA Manager ATMP is unique within the Quality Directorate. Leading the team that liaise with the Advanced Therapeutics team within the Clinical services directorate you will be responsible for ensuring regulatory compliance in all aspects of the Advanced Therapeutics operation. This includes leading and managing a team of up to 12 Quality Professionals in all aspects of this challenging field of medical science.
This includes technical transfer of methods, change control, deviation management supplier assurance and engagement directly with the regulators. Working in concert with NHSBTs Qualified Persons you will advise sponsors and operational leads on the regulations as they apply to each project.
Main duties of the job
In this role you will be required to provide expert advice, to all levels of the organisation including the Board and the Executive Team, on the complex, multi-stranded regulations relating to Advanced Therapies and Medicinal Products, Investigational Medicinal Products and Unlicensed Medicinal Products Specials. Your responsibilities will include:
- Acting as the Quality Assurance (QA) expert lead for Advanced Therapeutic and Medicinal Products (ATMPs).
- Working in concert with colleagues in CMT to ensure sufficient and suitable QA resource for current and future ATMP projects across all 5 manufacturing sites to ensure development and release of products meets both sponsor and regulatory requirements.
- Acting as QA lead for the sterile manufacture of all Cellular and Molecular Therapies, additionally providing input into aseptic processing of tissue products and reagents by acting as Chair of National Clean Room Advisory Group.
- Ensuring NHSBT fulfils its licensing obligations at all 5 manufacturing sites by providing suitable and sufficient QA resource.
- Dedicating support for inspection and supporting the development of post inspection corrective action plans.
- Leading on development and implementation of Quality Management Systems (QMS) specifically relevant to ATMP and in compliance with MIA (IMP) licences and other relevant licences for the manufacturing of ATMPs, by ensuring continued adherence to EU Good Manufacturing Practice (EU GMP).
About us
It takes all types of people to deliver the kind of service that saves and improves lives. At NHS Blood and Transplant, you'll join a team of more than 6,000 people who are making a genuine difference to communities, families, friends, relatives and more across the UK. We play a unique and special role in the NHS by helping people do something extraordinary- donate blood, blood products, organs, tissues, or stem cells to save someone in need.
Our three core values are what set us apart. They guide and inspire everything we do.
By being caring, expertly meeting the needs of our patients and our people, and accepting nothing less than the best quality, we can do extraordinary work and help our people to do something extraordinary in their career, too.
Three small words, one big difference - Caring, Expert and Quality. Together we'll save and improve more lives than ever.
You will join us on our journey to create an inclusive workplace and aim to reflect the diverse communities we work with, and we positively encourage applications from all sectors of the community.
Job description
Job responsibilities
Please view the attached recruitment profile which is a summary of the detailed Job Description and Person Specification for the full personal attributes we require for the role. You will need to demonstrate these throughout the recruitment process.
What we offer:
- A starting salary of £62,215 - £72,293 per annum in accordance with AfC.
- A full time and permanent job opportunity to join and lead as a Band 8b in NHSBT.
- Opportunity to work with a national organisation and be based in any of our major sites such as Bristol, London, Barnsley, Birmingham, Manchester and Liverpool.
- High-Cost Area Supplement (HCAS) on top of the base salary, where applicable.
- NHSBT promotes flexible working opportunities including hybrid working for this role.
- 27 days annual leave (pro rata for part-time) plus Bank Holidays, increasing to 29 days after 5 years service and to 33 days after 10 years.
- NHS pension scheme. The NHS Pension Scheme is a defined benefit scheme (not dependent on investment returns) Further details and outline of benefits can be found at: www.nhsbsa.nhs.uk/pensions
- Weve fostered a culture of continuous learning where colleagues are well-led, engaged, and encouraged to grow. We support you in reaching your full potential, both in your current role and future career. Our Thrive program embodies our commitment to learning and development, offering a wide range of activities to support your personal and professional growth. Its open to everyone at NHSBT, ensuring you have the resources to succeed and shine in your role.
This vacancy will close at 23:59 on Sunday 17th November 2024
Interviews are anticipated to be held on 29th November subject to confirmation
For informal enquiries please contact Heli Belfield, Lead Quality Specialist at helen.belfield@nhsbt.nhs.uk.
Job description
Job responsibilities
Please view the attached recruitment profile which is a summary of the detailed Job Description and Person Specification for the full personal attributes we require for the role. You will need to demonstrate these throughout the recruitment process.
What we offer:
- A starting salary of £62,215 - £72,293 per annum in accordance with AfC.
- A full time and permanent job opportunity to join and lead as a Band 8b in NHSBT.
- Opportunity to work with a national organisation and be based in any of our major sites such as Bristol, London, Barnsley, Birmingham, Manchester and Liverpool.
- High-Cost Area Supplement (HCAS) on top of the base salary, where applicable.
- NHSBT promotes flexible working opportunities including hybrid working for this role.
- 27 days annual leave (pro rata for part-time) plus Bank Holidays, increasing to 29 days after 5 years service and to 33 days after 10 years.
- NHS pension scheme. The NHS Pension Scheme is a defined benefit scheme (not dependent on investment returns) Further details and outline of benefits can be found at: www.nhsbsa.nhs.uk/pensions
- Weve fostered a culture of continuous learning where colleagues are well-led, engaged, and encouraged to grow. We support you in reaching your full potential, both in your current role and future career. Our Thrive program embodies our commitment to learning and development, offering a wide range of activities to support your personal and professional growth. Its open to everyone at NHSBT, ensuring you have the resources to succeed and shine in your role.
This vacancy will close at 23:59 on Sunday 17th November 2024
Interviews are anticipated to be held on 29th November subject to confirmation
For informal enquiries please contact Heli Belfield, Lead Quality Specialist at helen.belfield@nhsbt.nhs.uk.
Person Specification
Qualifications
Essential
- Educated to Masters degree or equivalent in a biological science or appropriate regulatory discipline. OR equivalent level of knowledge acquired through experience and further training/ development.
- Advanced theoretical and practical knowledge of a range of work procedures and practices, relevant to the manufacture of ATMPs.
- Demonstrates commitment to own continued professional development (CPD).
Experience
Essential
- Highly developed expert knowledge of one or more of the following: Good Manufacturing Practice, GAMP, and other regulations applicable to the manufacture of Advanced Therapeutic Medicinal Products which apply to the environment in which we work.
- Highly developed specialist knowledge and experience of the complex regulatory framework for Advanced Therapeutic Medicinal Products and Tissues.
- Experience of working and leading through influence with a wide range of stakeholders both internal and external.
- Expert knowledge of Quality Management Systems and the ability to lead change.
- An understanding and commitment to equality and diversity.
- Experience of working with information technology using Microsoft Office packages (Outlook, Word, Excel, Teams and PowerPoint).
Person Specification
Qualifications
Essential
- Educated to Masters degree or equivalent in a biological science or appropriate regulatory discipline. OR equivalent level of knowledge acquired through experience and further training/ development.
- Advanced theoretical and practical knowledge of a range of work procedures and practices, relevant to the manufacture of ATMPs.
- Demonstrates commitment to own continued professional development (CPD).
Experience
Essential
- Highly developed expert knowledge of one or more of the following: Good Manufacturing Practice, GAMP, and other regulations applicable to the manufacture of Advanced Therapeutic Medicinal Products which apply to the environment in which we work.
- Highly developed specialist knowledge and experience of the complex regulatory framework for Advanced Therapeutic Medicinal Products and Tissues.
- Experience of working and leading through influence with a wide range of stakeholders both internal and external.
- Expert knowledge of Quality Management Systems and the ability to lead change.
- An understanding and commitment to equality and diversity.
- Experience of working with information technology using Microsoft Office packages (Outlook, Word, Excel, Teams and PowerPoint).
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.
