Quality Assurance Manager

Salary: £33,966 to £36,024 with progression to £44,263 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: 02 June 2024

The Role

Access to human tissue and laboratory samples is essential for many aspects of translational and clinical research.

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 the full range of 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 expert 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, 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 feel this is you, we would love to hear from you. Contact Gill Robson at gillian.robson4@nhs.net to have a confidential discussion about the role.

We are currently operating a hybrid approach to working and can support with relocation for candidates from outside of the region. We are also happy to discuss your flexible working requirements.

Interviews will be held on Wednesday 19th June at the Newcastle Joint Research Office, Regent Point, Gosforth.

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  

• 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

• 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
• 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 leaders and 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 clinical research

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 silver Athena Swan award in recognition of our good employment practices for the advancement of gender equality.  We also hold a Race Equality Charter Bronze 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: 27058

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