Senior Quality Assurance Manager

Corehr; Oxford; On-site; GBP 49,000 - 58,000; Full time

Job summary

Oxford Vaccine Group at Churchill Hospital in Oxford is seeking a Senior Quality Assurance Manager to provide strategic leadership for quality assurance across its clinical research portfolio.

You will drive the QMS, SOPs and QA programs, oversee audits, CAPA, and regulatory compliance, and foster a culture of quality and continuous improvement within a collaborative team.

Qualifications

• Must hold a BSc or equivalent and relevant experience.
• Expert knowledge of ICH GCP and UK clinical trial legislation.
• Significant experience in a senior quality assurance role within regulated clinical research.
• Experience leading risk-based audit programmes, inspection readiness and CAPA management.
• Excellent analytical, communication, influencing and organisational skills.
• Experience in leading, developing and managing staff.

Responsibilities

• Lead the development and continuous improvement of the QMS, SOPs and broader quality frameworks.
• Provide strategic quality oversight across the clinical trial portfolio.
• Oversee management of quality incidents, non-conformances and CAPA.
• Advise on regulatory compliance, inspection readiness and quality-related risk.
• Promote a culture of quality, accountability and continuous improvement.

Skills

Quality Assurance

Audit management

CAPA management

Regulatory compliance

Data integrity

Leadership

Communication

Education

BSc or equivalent

Job description

Department of Paediatrics, Oxford Vaccine Group, Churchill Hospital, Oxford

The Oxford Vaccine Group (OVG) is seeking a Senior Quality Assurance Manager to provide strategic leadership for quality assurance and support the delivery of high-quality clinical research.

About the role

In this role, you will lead the development, implementation and continuous improvement of OVG's Quality Management System (QMS), quality policies, Standard Operating Procedures (SOPs) and wider quality frameworks that underpin OVG’s research portfolio. You will provide strategic quality oversight across the clinical trial portfolio, lead risk-based quality assurance activities including audits, quality metrics and governance processes, and oversee the management of quality incidents, non-compliances and CAPA. You will also provide expert advice on regulatory compliance, inspection readiness and quality-related risk, while promoting a culture of quality, accountability and continuous improvement.

OVG has a UKCRC-registered Clinical Trials Unit and is a recognised centre of excellence in vaccine research for both adult and paediatric populations. Based at the Churchill Hospital, our mission is to reduce the global burden of death and disability from infectious diseases. Working closely with an embedded laboratory team and international collaborators, we conduct studies spanning the full vaccine development pathway - from early preclinical research to late-stage post-licensure trials.

You will be working in a growing department within the Medical Sciences Division. The Department of Paediatrics is a world leader in child health research and hosts internationally renowned research programmes in drug development, gastroenterology, haematology, HIV, immunology, neuroimaging, neuromuscular diseases and vaccinology.

This post is full-time for two years in the first instance, with any extension subject to the availability of external funding. The successful postholder will be required to work on-site. Home working may be possible in certain circumstances and with prior approval.

About the department

The Department of Paediatrics is committed to equality and valuing diversity. The Department of Paediatrics has been honoured with the Athena Swan Gold award, a national gender equality charter, recognising the Department's innovative policies and practices. We are committed to the professional development of our staff by providing up to ten paid days annually for skill enhancement and allowing applications for additional training funding. By joining us, you will have the opportunity to contribute to a forward-thinking department.

We welcome new staff with ideas who are willing to shape the future of the department that thinks about its staff and wellbeing. In addition to the University of Oxford healthcare and wellbeing resources , the Department of Paediatrics sponsors weekly exercise classes such as yoga and bootcamp sessions as well as a choir. For staff on work visas, we also offer financial assistance towards visa renewal fees.These activities are designed to promote physical and mental wellbeing among staff members.

Please visit ourwebsite to find out more about the Department.

About you

The successful candidate will hold a BSc or equivalent experience relevant to the role. Expert knowledge of ICH GCP, applicable UK clinical trial legislation, research governance, and data integrity is essential, as is substantial experience in a senior Quality Assurance role within a regulated clinical research environment. You will bring significant experience of risk-based audit and quality assurance programmes, inspection readiness and CAPA management, alongside excellent analytical, communication, influencing and organisational skills. Experience of leading, developing and managing staff is also required.

Benefits

• up to ten paid days annually for skill enhancement
• allowing applications for additional training funding
• weekly exercise classes such as yoga and bootcamp sessions as well as a choir
• financial assistance towards visa renewal fees
• The Department of Paediatrics offers an Interview Expense Reimbursement Policy in its efforts towards equality, diversity and inclusion.

Salary (£) : 49,119 - 58,265 with a discretionary range to £63,489 per annum (pro-rata)