Senior Quality Assurance Manager

Overview

In this role you drive quality at the Oxford Vaccine Group, shaping the Quality Management System and governance for a portfolio of clinical trials. You provide expert QA leadership, guiding risk-based audits, CAPA, and regulatory compliance to support high-quality infectious disease research. You’ll collaborate with an embedded lab and international partners to sustain inspection readiness and continuous improvement. This is a chance to shape quality culture in a renowned vaccine research environment.

Pay / Benefits

• Athena Swan Gold award
• up to ten paid days annually for skill enhancement
• additional training funding opportunities
• visa renewal fee assistance
• on-site wellbeing activities (yoga, bootcamp, choir)
• flexible/home working where approved

Responsibilities

• Develop, implement and continuously improve the QMS, quality policies, SOPs and quality frameworks
• Provide strategic QA oversight across the clinical trial portfolio
• Lead risk-based QA activities including audits, quality metrics and governance processes
• Oversee management of quality incidents, non-compliances and CAPA
• Offer expert guidance on regulatory compliance and inspection readiness
• Promote a culture of quality, accountability and continuous improvement
• Collaborate with laboratory and international collaborators to support vaccine research programs

Key requirements

• BSc or equivalent experience in a relevant field
• Expert knowledge of ICH GCP, UK clinical trial legislation, research governance and data integrity
• Substantial experience in a senior QA role within a regulated clinical research environment
• Experience of risk-based audit and QA programmes, inspection readiness and CAPA management
• Strong analytical, communication, influencing and organisational skills
• Experience in leading, developing and managing staff

• communication
• influencing
• organisational skills
• ICH GCP
• UK clinical trial legislation
• data integrity

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