Quality Assurance Manager

Overview

You will provide expert QA oversight to support high-quality clinical research at OVG. You’ll lead the development, implementation and improvement of the Quality Management System, policies and SOPs, ensuring integrity across studies. Expect independent QA oversight, risk-based audits, and CAPA management while advising on regulatory compliance and inspection readiness. The role sits in a busy paediatric-focused research department and offers the chance to shape quality culture across the trial lifecycle.

Pay / Benefits

• Up to ten paid days annually for skill enhancement
• Additional training funding applications
• Visa renewal financial assistance
• Wellbeing activities (yoga, bootcamp, choir)
• On-site role with potential home working in some circumstances
• Athena Swan Gold award and commitment to equality and staff development

Responsibilities

• Lead development, implementation and continuous improvement of the QMS, quality policies, and SOPs
• Provide independent quality oversight across allocated clinical studies
• Lead risk-based internal audits and monitoring activities
• Manage quality incidents, non-compliances and CAPA
• Advise on regulatory compliance, inspection readiness and quality risk throughout the trial lifecycle
• Promote a culture of quality and continuous improvement

Key requirements

• BSc or equivalent experience
• Extensive knowledge of ICH GCP, UK clinical trial legislation and data integrity
• Experience planning, conducting and reporting internal audits, identifying findings, managing CAPA, and supporting continuous improvement
• Strong analytical, communication, influencing and organisational skills
• Experience of electronic quality management systems and risk assessment; ability to work independently

• Analytical thinking
• Effective communication
• Influencing and stakeholder management
• Electronic quality management systems
• Quality risk management
• CAPA handling

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