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Assistant Quality Assurance Manager

2 months ago

Liverpool, United Kingdom NHS Blood and Transplant Full time

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 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 is a full time, fixed term post for 2 years. Secondments will be considered for Internal staff wishing to apply – however please discuss with your current line manager before submitting an application.

Please note, following changes to UK immigration policy from April 4th, for sponsorship eligibility for this role please refer to the UK Visas and Immigration guidance on Skilled Worker Visa’s.

Main duties of the job

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:

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. Deputising for the Quality Assurance Manager and assisting Lead Quality Specialists and the Regional Quality Assurance Manager(s) when required. 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. 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. Participating in Operational Improvement events using LEAN principles and projects or workshops to identify areas for and methods to improve the services we provide. Supporting all areas of Quality Assurance for the Advanced Therapy Unit (ATU) and the Clinical Biotechnology Centre (CBC) in the production of ATMPs / IMPs.

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

Extensive experience of working in a regulated environment e.g. Pharmaceutical Manufacturing, NHSBT or equivalent. Experience of quality audit and use of Quality Management Systems. 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. Experience of working with information technology using Microsoft Office packages (Word, Excel and PowerPoint), or equivalent Systems.

Qualifications and Training

Masters level qualification OR equivalent relevant experience. Basic management qualification or short courses in line management, OR relevant experience in managing others. Demonstrate commitment to own Continued Professional Development (CPD).