As a key member of the NHSBT Reagents Senior Management Team, you will play a pivotal role in ensuring our products, processes, and quality systems meet the highest regulatory and compliance standards. You will provide expert leadership in maintaining compliance with ISO 13485, GMP, IVDD/IVDR requirements, and the NHSBT Quality Management System, helping to safeguard product quality and patient safety.
You will be responsible for the creation, maintenance, and oversight of medical device technical documentation, ensuring regulatory requirements are consistently met. Acting as a Quality release signatory, you will review Batch Manufacturing Records, approve product release, and authorise lot-specific Certificates of Conformance while maintaining robust manufacturing and release records.
The role also involves monitoring and analysing quality performance indicators, identifying trends and opportunities for continuous improvement. Working collaboratively with Quality Project Specialists and cross-functional teams, you will support ongoing regulatory compliance initiatives and quality improvement projects.
In addition, you will plan, lead, and conduct internal quality audits across NHSBT Reagents operations, driving compliance, promoting best practice, and supporting a culture of quality throughout the organisation.
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Be conversant with laboratory processes and practices, in RCI, H&I, Testing, and hospital transfusion laboratories in relation to regulatory requirements and the impact on Reagents’ products.
- Actively deliver and report on day-to-day compliance regulations and guidelines relating to Reagents, including but not limited to Blood Safety and Quality Regulations, Good Manufacturing Practice, ISO13485, Guidelines for UK transfusion services, in vitro diagnostic devices, and British Standards in Haematology guidelines.
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Keep abreast of scientific developments in the industry and apply such information to the benefit of the service and of customers.
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Provide regulatory support in the development of new product, services and procedures across the Reagents function.
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Actively pursue savings against budget.
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Provide specialist knowledge of Reagents product design, manufacture and application including product specifications.
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Contribute to, and participate in, the strategic direction and development of the service.
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Play a lead role in Reagents’ change controls in particular ensuring compliance to regulations.
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Work with local and national Quality Managers to operate within NHSBT’s quality management system.
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To manage a system for the analysis of all Reagents’ quality incidents, customer contacts and audit findings for review by senior RCI and QA staff.
Experience and Knowledge
- Well-developed specialist knowledge in reagents production and regulatory compliance.
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Experience of working in a highly regulated environment, relevant to diagnostic services including in depth knowledge of standards and guidelines affecting laboratory practice and reagents production.
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Skilled in audit, validation of equipment, processes, research and development activity.
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Experienced in working with spreadsheets, data analysis and standard word software packages.
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In depth understanding of NHSBT and wider healthcare community.
Qualifications and Training
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First Level sciences degree.
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Post HCPC registration qualification.
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Willingness to work towards and complete MSc or FIMBS within 3 years of registering on the course.
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Demonstrate commitment to own Continued Professional Development (CPD).
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Requirement for HCPC professional registration required (which must be maintained in the role).
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.
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Flexible working options we promote flexible working where the role allows. We’re happy to discuss what flexibility might look like for you.
- Generous annual leave - 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.
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Inclusive 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: http://www.nhsbsa.nhs.uk/information-about-nhs-pensions
- Supportive learning culture - we’ve 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. It’s open to everyone at NHSBT, ensuring you have the resources to succeed and shine in your role.
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Health and wellbeing support we offer confidential services including occupational health, employee assistance programme, and wellbeing resources. Our support is available to all colleagues and we endeavour to provide tailored workplace adjustments where possible.
As a Disability Confident Employer, we welcome applications from disabled candidates. We will talk with you to explore any adjustments that may help you during the recruitment process.
You can find more information about accessibility, our culture, and how we support applicants on the NHSBT Careers website:
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Read about our application process
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Learn more about our culture at NHSBT
To learn more, please see the job description and person specification. These can be accessed via the link below, or by clicking ‘Apply’ if you are viewing this advert on another site.
This vacancy will close at 23:59 on Sunday 16th August.
The assessment process for this role will include: a single interview.
Interviews are anticipated to be held on 1st or 2nd September subject to confirmation.
For informal enquiries please contact
Name: Charlotte Walker
Job Title: Recruiter
Contact Details: [email protected]
