Associate Director Quality Assurance

About the Organisation

A science-led, international life sciences company operating in a highly regulated development environment is expanding its Quality function. The organisation works across early and clinical development stages and partners extensively with external service providers globally.

We are hiring a Senior Manager / Associate Director, Clinical & Preclinical Quality to support development activities across clinical and non-clinical programs. The role works closely with senior quality leadership and cross-functional stakeholders to ensure strong GCP and GLP compliance
, robust data integrity, and inspection readiness.

This is a hands-on quality role suited to an experienced professional with a strong background in clinical quality, preclinical/GLP oversight, and early development
, who is comfortable operating in a dynamic, international environment.

• Provide quality oversight for multiple clinical development activities
• Support GCP compliance across internal teams and external partners
• Contribute to inspection readiness and regulatory interactions
• Review and approve clinical quality documentation and procedures

• Provide quality oversight for preclinical, toxicology, and laboratory studies
• Plan, conduct, or manage GLP audits of CROs and external laboratories
• Ensure studies are conducted in line with GLP requirements and internal standards
• Support program transition from early development into clinical stages

• Execute and manage audits of CROs, laboratories, and service providers
• Support CAPA management and continuous improvement activities
• Contribute to vendor qualification and ongoing oversight

• Support the development and maintenance of GCP/GLP quality systems
• Contribute to internal training on quality and compliance requirements
• Promote strong documentation practices and data integrity

• 5–10+ years’ experience in GCP Quality Assurance within biotech, pharma, or CRO settings
• Hands‑on experience with GLP and preclinical program oversight
• Experience supporting early development and translational activities
• Proven track record conducting and managing vendor and CRO audits
• Solid knowledge of ICH, GCP, GLP, and global regulatory expectations

• Experience in growing or evolving organisations
• Exposure to complex or regulated development programs

• Highly organised, detail-oriented, and quality-focused
• Strong communication and stakeholder management skills
• Comfortable working both independently and collaboratively
• Able to balance strategic thinking with hands‑on execution