Job Summary
Whether your background is in pharmaceutical manufacturing or any other medical quality management or auditing field; few organisations offer the impact of NHS Blood and Transplant. You’ll work with teams the length and breadth of the country to implement ever-improving best practices. In doing so, making sure our blood, tissue and organ donations safely save millions of lives.
As you’d expect, our quality management and compliance systems are crucial to our success. You’ll be their champion: keeping licenses up to date, helping teams follow guidelines, recording and reporting on evidence, and managing audits. Anything and everything that keeps us working in the most efficient and safest way. There’ll be some time behind a desk; but this is really a people-centric role. We’ll expect you to meet teams, government agencies and regulators, develop tailored solutions and respond to any incidents.
You’ll be required to produce written reports, including closure statements for events. These statements will be bespoke for each event. You’ll need to be able to write various reports manually, using clear and concise language.
A background in pharmaceutical or medical quality management would be advantageous and, ideally, a relevant post-graduate qualification (or equivalent). It’s important you’re also a consummate professional who can build strong relationships and ask the right questions while keeping an objective view of the work.
Main duties of the job
In this role you will support the Quality Assurance Manager (QAM) in the maintenance and development of the Quality Assurance function of the site. Your responsibilities will include:
1. Working with the Quality Assurance Managers and Quality Project Specialists to maintain compliance with all relevant licensing and accreditation standards and improve service delivery to customers by working in partnership with all stakeholders.
2. Developing subject matter expertise in quality management system processes and deliver training of these processes to the wider Quality Directorate.
3. Deputising for the Quality Manager and Regional Quality Manager as required.
4. Day to day involvement with colleagues of varying levels of seniority in many departments and centres regarding all elements of the Quality system including adverse events, audit non-conformities, change control & validation, concessionary issue and recalls.
5. Developing relationships with external organisations and ensuring that any external requirements are incorporated safely into the Quality system.
6. Producing reports and leading quality review meetings with department managers as well as facilitating meetings to investigate adverse events to their root cause and identify effective actions to prevent re-occurrence.
7. Participating in Operational Improvement events using LEAN principles and projects or workshops to identify areas for and methods to improve the services we provide.
You will be required to travel throughout the UK and spend some time away from base, which will involve working irregular hours and overnight stays when required, with prior notice.
About You
Experience and Knowledge
8. Extensive experience of working in a regulated environment e.g. Pharmaceutical Manufacturing, NHSBT or equivalent.
9. Experience of quality audit and use of Quality Management Systems.
10. Understanding of relevant UK legislation and guidelines, e.g. Good Manufacturing Practice, Good Practice Guidelines for Blood Transfusion, ISO, General Data Protection Regulations and Freedom of Information; and any other appropriate statutory guidelines.
11. Experience of working with information technology using Microsoft Office packages (Word, Excel and PowerPoint), or equivalent Systems.
Qualifications and Training
12. Masters level qualification or equivalent relevant professional qualifications or demonstrable knowledge and experience at Masters level
13. Basic Management Qualification or short courses in line management or relevant experience in managing others.
14. Demonstrate commitment to own Continued Professional Development (CPD).