Quality Assurance Manager
The closing date is 08 January 2026
We are pleased to advertise the vacancy of Quality Assurance Manager for the Clinical Research Directorate. Based within the Newcastle Joint Research Office (NJRO), the post holder will be responsible for the oversight of the department's Quality Management System (QMS) and annual audit plan. The post holder will support several teams across the NJRO with regulatory and governance affairs and provide strategic input on the future direction of the department.
The post holder will also interact with all delivery teams across the directorate, providing advice, support and key decision making, in relation to quality and audit. The post holder will also lead a team of quality assurance specialist in the areas of Good Clinical Practice (GCP) and Human Tissue Authority (HTA). A key element of the role is to support the Directorate with regulatory inspections and provide advice across several key stakeholders, within Newcastle Hospitals but also across regional partner organisations.
Interview date: Thursday 29 January 2026. Please apply via Trac. Expand the job details section and read all information before applying.
NO AGENCIES PLEASE
Main duties of the job
* Ensure that the annual audit plan is approved and completed
* Provide data in relation to key audit findings and solutions to the Senior Management Team
* Ensure that the quality policy and manual are maintained and fit-for-purpose
* Provide support and advice for processes and standard operating procedures
* Support the NJRO Lead with key decision making and strategy
* Provide line manager for a mixed team of Newcastle Hospitals and Newcastle University staff
* Report to appropriate committees and boards
* Provide key advice and support for regulatory inspections
* Be a key player in Corrective and Preventative planning
* Ensure risk assessments are completed for particular regulatory and governance matters
* Work closely with external stakeholders to ensure quality across partners within the North East and North Cumbria
* Support the Directorates approach to digitalisation
About us
As a flexible working friendly organisation, we want to be sure that you can work in a way that is best for us and for our patients, and for you. Speak to us about how we might be able to accommodate a flexible working arrangement. If it works for the service, we will do our best to make it work for you.
With around 2 million contacts with patients every year, we deliver care from:
* Royal Victoria Infirmary (RVI)
* Freeman Hospital
* Newcastle Dental Hospital
* Newcastle Fertility Centre
* Northern Centre for Cancer Care, North Cumbria
* Northern Genetics Service
These include a range of flagship services which deliver cutting‑edge care (supported by state‑of‑the‑art diagnostic services in both radiology and pathology) and are a catalyst for innovation to support pioneering clinical practice in the NHS.
We also have offices at Regent Point in Gosforth and community sites.
Please see attached information on the Staff Benefits we have to offer at our Trust under “Documents to download” or “Supporting documents”.
For further information on The Newcastle upon Tyne Hospitals NHS Foundation Trust please visit the Trust website.
Job responsibilities
The post holder will support the Head of the Joint Research Office in leading, developing and coordinating quality management systems in support of the research activity taking place on behalf of the Trust, ensuring patient safety and research data validity, including:
* Ensuring all processes contributing to the performance of any trials are conducted in accordance with ICH‑GCP guidelines, relevant SOPs and other regulations.
* Developing a Quality Management System, the focus of which is to develop, perform and manage quality assurance‑relates activities from policy level through to coordinating appropriate SOP development, ensuring compliance via undertaking a risk‑adaptive audit programme.
* Ensure that audit results are formally and consistently recorded and reported and that corrective/preventive actions have been requested and documented effectively.
* Training of JRO staff and others as required (either directly or indirectly) regarding GCP, QA and regulatory audits.
The post holder will ensure that Sponsor and Regulatory audits are effectively executed and provide support and direction during the hosting of such audits as necessary, assisting the Research Governance Manager as required.
Person Specification
KNOWLEDGE
* Awareness of fundamental national and local NHS and R&D policies
* Evidence of relevant continuous professional development
SKILLS
* Excellent interpersonal and communication skills
* Organisation and planning skills
* Leadership and management skills
* Negotiation, persuasion and problem‑solving skills
* Project management skills and knowledge
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