Overview
A leading biotechnology organisation is seeking an experienced Executive Director, Clinical Quality Assurance to provide strategic leadership across clinical quality operations. This role is responsible for ensuring compliance with global regulatory standards (GCP, GVP, GLP) while driving continuous improvement in clinical quality practices.
Working closely with senior leaders across Quality, Discovery, and Development, you will shape and execute global and regional quality strategies aligned with pipeline objectives. This position plays a critical role in setting the vision, standards, and long-term direction of the Clinical Quality Assurance function.
Responsibilities
- Lead the development and execution of clinical quality assurance strategies, ensuring compliance with global regulations and industry standards
- Establish and maintain robust quality systems, including SOPs, policies, and quality documentation
- Drive continuous improvement initiatives to enhance quality, efficiency, and compliance across clinical operations
- Develop and implement risk management frameworks to identify, assess, and mitigate clinical risks
- Define and monitor key quality metrics and KPIs, providing regular updates to senior leadership
- Collaborate cross-functionally with clinical operations, regulatory, pharmacovigilance, and other teams to ensure alignment
- Build and lead a high-performing Clinical Quality Assurance team to support the clinical development portfolio
- Oversee vendor qualification, audit programmes, and ongoing compliance for external partners (e.g., laboratories, CMOs, depots)
- Develop and manage audit strategies for clinical sites and vendors
- Lead preparation and management of regulatory inspections, acting as the primary point of contact for health authorities
- Support training, inspection readiness, and remediation activities as required
- Promote a strong culture of quality and compliance across the organisation
Requirements
- Bachelor’s degree in a scientific discipline (advanced degree preferred)
- +10 years experience in GCP Quality roles
- Proven experience in both strategic and operational clinical quality assurance
- Strong understanding of GCP, GLP, GVP, and broader GxP requirements
- In-depth knowledge of regulatory requirements across multiple regions (e.g., US and EU)
- Excellent communication and stakeholder management skills
eireann.evans@meetlifesciences.com
