Director, Quality Assurance APAC

About the role

As Director of Quality Assurance for the APAC region, you will lead the independent second‑line assurance function for R&D, ensuring excellence in GxP auditing, risk assessment and quality management to protect patients and support innovative medicines.

Key responsibilities

• Develop and deliver a risk‑based GxP quality assurance program (GCP, GVP, GLP) across the APAC R&D portfolio.
• Plan, lead and report complex audits – investigator site, system, process and supplier audits.
• Provide strategic business partnering and advisory to senior R&D leaders and stakeholder groups.
• Monitor GxP risk and compliance intelligence, and communicate audit standards.
• Oversee regulatory GxP inspections, including strategy, preparation and pre‑inspection training.
• Drive CAPA assessment, development, approval and follow‑up for clinical activities.
• Conduct due‑diligence activities and manage outsourced audit resources.

Required profile

• Proven senior leadership experience in Quality Assurance within pharmaceutical R&D.
• Deep knowledge of GxP regulations (GCP, GVP, GLP) and audit methodologies.
• Strong stakeholder management skills with senior R&D executives.
• Experience delivering inspection support and CAPA oversight in the APAC region.

Required skills

• GCP (Good Clinical Practice)
• GVP (Good Pharmacovigilance Practice)
• GLP (Good Laboratory Practice)
• Complex audit planning and execution
• CAPA management
• Regulatory inspection strategy