GCP Auditor

Overview

We are supporting a global healthcare organization that seeks an experienced Good Clinical Practice (GCP) Auditor to enhance its international Clinical Quality team. This role is based in Singapore and involves auditing at investigator sites, clinical research organizations (CROs), and vendors. The successful professional will play a critical role in identifying quality risks and preparing for regulatory inspections within global clinical programs.

Key Responsibilities

• Conduct thorough audits of investigator sites, CROs, and vendors to assess compliance with GCP standards.
• Identify and communicate quality risks to relevant stakeholders.
• Support inspection readiness activities across diverse international clinical programs.
• Collaborate extensively with multinational Clinical Operations and Quality teams.
• Engage with regional stakeholders across the Asia-Pacific (APAC) region, leveraging language skills.

Qualifications and Experience

• Demonstrated experience in Clinical Quality Assurance within clinical development.
• Strong expertise in GCP auditing methodologies and execution.
• Proficiency in Mandarin is required to facilitate effective communication with regional stakeholders.

Additional Information

This position provides meaningful regional exposure in APAC and involves extensive collaboration with multinational teams.