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.
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.
This role will support the 3 northern ATMP sites (Barnsley, Liverpool and Birmingham) and there will be an expectation for the succussful applicant to travel to each site regularly dependant on current activity levels. The successful candidate is also expected to be on site 3 days a week.
Main duties
In this role you will support the Quality Assurance Manager - ATMP in the maintenance and development of the Quality Assurance function at the NHSBT Liverpool site. Your responsibilities will include:
1. Working with the Quality Assurance Manager to maintain compliance with all relevant licensing and accreditation standards for the site and improving service delivery to customers by working in partnership with all stakeholders.
2. Day to day involvement with colleagues of varying levels of seniority in many departments and centres regarding all elements of the Quality system including quality incidents, audit non-conformities, change control & validation and regulatory inspections.
3. 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.
4. Participating in Operational Improvement events using LEAN principles and projects or workshops to identify areas for and methods to improve the services we provide.
5. Supporting all areas of Quality Assurance for the Advanced Therapy Unit (ATU) and the Clinical Biotechnology Centre (CBC) in the production of ATMPs / IMPs.
6. Deputising for the Quality Assurance Manager and assisting Lead Quality Specialists and the National Quality Assurance Manager(s) when required.
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
7. 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.
8. Extensive experience of working in a regulated environment e.g. Pharmaceutical Manufacturing, NHSBT or equivalent.
9. Competent and confident user of IT e.g. Outlook, Word, PowerPoint and Excel.
10. Experience of working with information technology using Microsoft Office packages (Outlook, Word, Excel, Teams and PowerPoint).
Qualifications and Training
11. Masters level qualification or equivalent relevant professional qualifications or demonstrable knowledge and experience at Masters level.
12. Basic Management Qualification or short courses in line management or relevant experience in managing others.
13. Demonstrates commitment to own continued professional development (CPD).
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