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Quality Assurance ManagerAlfianni Online - Artist NetwerkPlayden, England, United Kingdom

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Quality Assurance Manager

Alfianni Online - Artist Netwerk
  • GB
    Playden, England, United Kingdom
  • GB
    Playden, England, United Kingdom

Über

Job Summary We are pleased to advertise the vacancy of Quality Assurance Manager for the Clinical Research Directorate of the Newcastle Joint Research Office (NJRO). The post holder will oversee the department’s Quality Management System (QMS) and annual audit plan, support regulatory and governance affairs, and provide strategic input to the directorate. They will lead a team of quality assurance specialists in Good Clinical Practice (GCP) and Human Tissue Authority (HTA) and support the Directorate with regulatory inspections across Newcastle and regional partners.
Flexible working is supported; arrangements may be accommodated if they do not affect service provision.
Responsibilities
Ensure that the annual audit plan is approved and completed.
Provide data relating to key audit findings and solutions to the Senior Management Team.
Maintain and ensure the quality policy and manual are fit‑for‑purpose.
Support and advise on processes and standard operating procedures.
Assist the NJRO Lead with key decision‑making and strategy.
Line‑manage a mixed team of Newcastle Hospital and Newcastle University staff.
Report to appropriate committees and boards.
Provide key advice and support for regulatory inspections.
Lead corrective and preventative action planning.
Ensure risk assessments are completed for regulatory and governance matters.
Work closely with external partners to maintain quality across the North East and North Cumbria.
Support the Directorate’s digitalisation initiatives.
Develop and manage the QMS, coordinating SOP development and a risk‑adaptive audit programme.
Ensure audit results are recorded and reported, and that corrective/preventive actions are documented.
Provide training on GCP, QA and regulatory audits to staff.
Qualifications
Masters level qualification or equivalent experience.
Evidence of relevant continuous professional development.
Person Specification Essential Knowledge
Awareness of fundamental national and local NHS and R&D policies.
Essential 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.
Research and audit skills.
Broad IT skills.
Service improvement and 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 in multiple settings 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.
Experience conducting pharmacovigilance audits.
Job Details
Seniority level:
Mid‑Senior level
Employment type:
Full‑time
Job function:
Information Technology
Industries:
IT System Testing and Evaluation
Location:
Regent Point, 317 Regent Point, NE3 3HD, Newcastle upon Tyne
Reference number:
317‑2025‑48‑025
Band:
8a
Salary:
£55,690 to £62,682 per annum
Pay scheme:
Agenda for Change
Contract:
Permanent
Working pattern:
Full‑time, 37 hours 30 minutes per week
Additional Information Disclosure and Barring Service Check:
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975. A Disclosure and Barring Service check will be required.
Certificate of Sponsorship:
Applications requiring current Skilled Worker sponsorship are welcomed and will be considered alongside other applications.
Employer: Newcastle upon Tyne Hospitals NHS Foundation Trust
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  • Playden, England, United Kingdom

Sprachkenntnisse

  • English
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