Quality Assurance Manager

Salary: 36636 to 38784 with progression to 46049 per annum

Newcastle University is a great place to work with excellent benefits. We have a generous holiday package; plus the opportunity to buy more great pension schemes and a number of health and wellbeing initiatives to support you.

Closing Date: 6 September 2026

The Role

Based in the Newcastle Joint Research Office the Quality Assurance Manager will provide professional support to Newcastle University (University) and Newcastle Hospitals NHS Foundation Trust (Trust) Designated Individuals (DIs) in discharging their responsibilities in line with relevant legislative and regulatory requirements.

We are looking for candidates who are familiar with Human Tissue Authority (HTA) codes of practice and the associated legislative and regulatory landscape including Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP).

In this role you will provide advice and drive the co-ordination and maintenance of governance support for research using human tissue and laboratory samples including samples registered under the University and Trust HTA Research Licenses. You will also ensure compliance to GCP and GCLP.

We are looking for someone who is solutions focused comfortable working in complexity a team player and is keen to learn develop and share learning and best practice locally regionally and nationally to ensure that Newcastle continues to be recognised for its excellence and high standards in translational and clinical research.

If you would like to informally discuss the role further please contact David Hill Director of Research & Innovation on or Sophie Handson Quality Assurance Manager on

This role is for a fixed term of 12 months.

Key Accountabilities

• Proactively support the DIs and Persons Designated to ensure compliance with the University and Trust HTA Research Licences
• As part of a wider Quality Assurance Team in the Newcastle Joint Research Office (NJRO) work with colleagues in the University and the Trust to ensure access to human tissue and laboratory samples for research are compliant with GCP GCLP principles and regulatory expectations where appropriate
• Continually maintain and review the processes and procedures within the NJRO Quality Management System which underpin research using human tissue and laboratory samples capitalising on good practice not only at Newcastle but through established networks across the UK
• Independently conduct periodic internal audits of human tissue and laboratory sample collections stored across University and Trust premises including samples held under the Human Tissue Act and as part of NHS Research Ethics Committee (REC) approved projects to ensure not only compliance with legislation but also local policies and procedures as set out in the Quality Manual
• Confidently issue appropriate feedback on areas of good practice or requiring improvement and oversee implementation of any recommended actions
• Co-ordinate and lead on interactions with external regulators including requests for information on-site preparation and facilitation of audits for the University and the Trust
• Working with colleagues in the University and the Trust develop deliver and maintain a suite of training and development opportunities as well as providing regular updates for colleagues involved in overseeing and delivering research using human tissue and laboratory samples which forms part of their personal and professional development
• Through keeping up to date with technical developments and legislations provide expert advice guidance and support to colleagues with regards to all aspects of research using human tissue and laboratory samples including HTA codes of practice compliance with GCP and GCLP principles and associated regulations requirements for study set up sample access ethical approval local policies and procedures and regulatory requirements
• Provide regular reports to University and Trust quality committees on audit findings and recommended actions as a result of audit findings to embed a culture of continuous improvement

The Person

Knowledge Skills and Experience

• Knowledge and understanding of the regulatory environment relating to research involving human tissue and laboratory samples
• Excellent networking and negotiation skills and ability to easily work with colleagues across multiple disciplines at all levels
• Excellent report writing presentation and communication skills which can be adapted according to the audience
• Excellent administrative and organisational skills
• Experience in the conduct of or participation in regulatory audits
• Experience in the production review and updating of risk assessments
• Experience of working in a regulated laboratory/research environment
• Experience of working with and influencing senior leadersand managers
• Experience of working independently across multiple sites

Attributes and Behaviour

• Role model the collaborative and partnership approach which is embedded throughout the NJRO to facilitate working across organisational boundaries
• Promotes a culture of mutual respect
• People orientated is approachable and can motivate and engage others
• Able to manage conflicting priorities
• Able to handle conflict in a timely and effective way bringing solutions to a speedy resolution
• Solutions focussed act objectively flexibly and pragmatically taking into account the regulatory environment
• Always seeking to continuously improve personally and professionally and improve the overall experience of those working in and benefitting from clinicalresearch

Qualifications

• Relevant graduate qualification and/or equivalent substantial experience working in a regulated laboratory/research environment

Newcastle University is a global University where everyone is treated with dignity and respect. As a University of Sanctuary we aim to provide a welcoming place of safety for all offering opportunities to people fleeing violence and persecution.

We are committed to being a fully inclusive university which actively recruits supports and retains colleagues from all sectors of society. We value diversity as well as celebrate support and thrive on the contributions of all of our employees and the communities they represent. We are proud to be an equal opportunities employer and encourage applications from individuals who can complement our existing teams we believe that success is built on having teams whose backgrounds and experiences reflect the diversity of our university and student population.

At Newcastle University we hold a GoldAthena Swan award in recognition of our good employment practices for the advancement of gender equality. We also hold a Race Equality CharterBronze award in recognition of our work towards tackling race inequality in higher education REC. We are a Disability Confident employer and will offer an interview to disabled applicants who meet the essential criteria for the role as part of the offer and interview scheme.

In addition we are a member of the Euraxess initiative supporting researchers in Europe.

Requisition ID: 29611

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