Auditor - GCP, Singapore

About the role

The GCP Auditor will join the Research & Development Quality audit program, executing the global audit plan to safeguard the accuracy of clinical trial data and ensure compliance with regulatory and corporate standards. This position works closely with clinical sites, CROs, E‑System providers and IRBs to maintain the integrity of our clinical research.

Key responsibilities

• Conduct external audits of clinical investigator sites, CROs, E‑System providers and Institutional Review Boards.
• Prepare comprehensive audit reports, categorize findings by risk level and recommend corrective and preventive actions.
• Analyse non‑compliance trends and communicate systematic risks to line management and functional leads.
• Support continuous improvement initiatives for audit SOPs and develop risk‑based solutions for trial management.
• Maintain up‑to‑date knowledge of global GCP regulations (ICH E6) and emerging industry requirements.

Required profile

• Bachelor’s degree in a biological science, life science or related discipline.
• Minimum 3 years of Quality Assurance experience in a GCP‑regulated environment.
• At least 3 years of inspection experience with China’s NMPA (formerly CFDA).
• Proven experience in clinical audit and inspection management.
• Excellent interpersonal and negotiation skills with multinational teams.
• Professional fluency in Mandarin Chinese (written and spoken).

Required skills

What we offer

• Opportunity to influence global clinical quality standards.
• Collaborative, multinational work environment.
• Professional development in regulatory affairs and audit excellence.