Quality Assurance ManagerAlfianni Online - Artist Netwerk • Playden, England, United Kingdom
Quality Assurance Manager
Alfianni Online - Artist Netwerk
- Playden, England, United Kingdom
- Playden, England, United Kingdom
Über
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 lead a team of quality assurance specialists 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 Hours per week: 37 hours 30 minutes Application process: Redirect to Trac – expand the job details section and read all of the information before applying. NO AGENCIES PLEASE Main duties of the job
Ensure that the annual audit plan is approved and completed. Provide data on 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 Directorate’s approach to digitalisation. About Us
As a flexible working friendly organisation, we aim to accommodate flexible arrangements that benefit both the service and the employee. We serve around 2 million patients each year across sites including: Royal Victoria Infirmary (RVI) Freeman Hospital Newcastle Dental Hospital Cramlington Manor Walks Urgent treatment centres Newcastle Fertility Centre Northern Centre for Cancer Care, North Cumbria Northern Genetics Service Additional offices: Regent Point in Gosforth and community sites. For more information on staff benefits, see the Trust documents. Job details
Date posted:
02 January 2026 Pay scheme:
Agenda for change Band:
8a Salary:
£55,690 to £62,682 per annum Contract:
Permanent Working pattern:
Full‑time Reference number:
317-2025-48-025 Job location:
Regent Point, 317 Regent Point, NE3 3HD Employer name:
The Newcastle upon Tyne Hospitals NHS Foundation Trust Employer's website:
https://careers.nuth.nhs.uk/why-us Job responsibilities
Support the Head of the Joint Research Office in leading, developing and coordinating Quality Management Systems for research activities on behalf of the Trust, ensuring patient safety and research data validity. Ensure all trial processes comply with ICH‑GCP guidelines, relevant SOPs, and regulatory requirements. Develop, perform and manage quality assurance activities from policy level through coordination of SOP development, implementing a risk‑adaptive audit programme. Record, report and ensure corrective/preventive actions are documented effectively following audit results. Provide training to JRO staff and others on GCP, QA and regulatory audits. Ensure sponsor and regulatory audits are executed effectively; provide support and direction during audits as required, assisting the Research Governance Manager. Person Specification
Knowledge Awareness of fundamental national and local NHS and R&D policies. Evidence of relevant continuous professional development. Essential Skills Excellent interpersonal and communication skills. Organisation and planning skills. Leadership and management skills. Negotiation, persuasion and problem‑solving skills. Project management knowledge. Research and audit skills. Broad IT skills. Service improvement/change management skills. Well‑developed report writing, analytical and presentation skills. Essential Experience Extensive theoretical and practical experience of research governance, audit and policy development to Masters level or equivalent. Proven experience in a GCP environment and/or quality setting, including policy development. Experience preparing for external inspections. Experience monitoring compliance with national risk management/quality standards. Ability to work strategically. Desirable Experience in a corporate leadership role. Extensive experience conducting pharmacovigilance audits. Essential Qualifications Masters level qualification or equivalent experience. Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975. A submission for Disclosure to the Disclosure and Barring Service (formerly CRB) is required to check for any previous criminal convictions. Certificate of Sponsorship
Applications for skilled worker sponsorship are welcome and will be considered alongside all other applications. For further information, visit the UK Visas and Immigration website.
#J-18808-Ljbffr
Sprachkenntnisse
- English
Hinweis für Nutzer
Dieses Stellenangebot stammt von einer Partnerplattform von TieTalent. Klicken Sie auf „Jetzt Bewerben“, um Ihre Bewerbung direkt auf deren Website einzureichen.