GCP Auditor - APAC

Walker Cole International is supporting an exciting opportunity within a leading biotechnology organisation across APAC in the appointment of a GCP Auditor.

The position will focus on clinical quality oversight, ensuring that clinical trials are conducted in compliance with ICH-GCP guidelines, local regulatory requirements, and the sponsor’s quality standards across multiple APAC regions.

Key responsibilities:

• Provide GCP audit support across clinical trial sites, vendors, and internal processes.
• Conduct investigator site audits, vendor audits, and system/process audits.
• Ensure compliance with ICH-GCP, local regulatory requirements, and internal SOPs.
• Support CAPA management, including tracking, follow-up, and effectiveness checks.
• Identify quality risks and provide recommendations for continuous improvement.
• Collaborate with clinical operations and regulatory teams across APAC.
• Prepare detailed audit reports and present findings to stakeholders.
• Support inspection readiness and regulatory authority inspections.
• Drive quality culture and compliance across global clinical programs.

Required experience and skills:

• Significant experience in GCP auditing within clinical research or biotechnology environments.
• Strong knowledge of ICH-GCP guidelines and international clinical regulations.
• Proven track record conducting site, vendor, and system audits.
• Experience with CAPA management and audit lifecycle processes.
• Strong communication and stakeholder management skills across multicultural teams.
• Ability to work across multiple APAC jurisdictions and regulatory frameworks.
• Fluency in English is essential; additional APAC languages are advantageous.
• Minimum of 5–8 years’ relevant experience in GCP quality or auditing roles.

Working pattern:
Immediate availability for an audit

Employment type:
Contract

Hourly rate:
$100-120

Location:
APAC

Duration:
One-off 

Keywords:
GCP Auditor | Clinical Quality | ICH-GCP | Clinical Trials | Auditing | CAPA | Vendor Audits | Inspection Readiness | Biotechnology | APAC