Regional GCP Auditor

Barrington James; Kuala Lumpur; On-site; MYR 180,000 - 240,000; Full time

Job summary

Barrington James is partnering with a leading multinational healthcare organization to appoint a Regional GCP Auditor for the APAC Quality function in Malaysia. This role reports into the global R&D Quality leadership, strengthening clinical quality, inspection readiness, and GCP compliance across multinational programmes.

You will lead audits of investigator sites, CROs, vendors and Ethics Committees, support CAPA, and contribute to global quality strategies.

Qualifications

• Professionals with GCP Quality Assurance and Clinical Auditing experience, particularly those with experience auditing investigator sites, CROs and clinical vendors, are encouraged to apply.
• Professional Mandarin language capability is essential due to regular interaction with regional stakeholders and clinical partners across Greater China.

Responsibilities

• Lead and execute GCP audits across investigator sites, CROs, vendors, E-system providers and Ethics Committees throughout the APAC region.
• Assess compliance with global GCP regulations including ICH E6, 21 CFR requirements and international clinical research standards, ensuring the integrity of clinical trial data and patient safety.
• Prepare comprehensive audit reports, perform risk assessments, identify compliance trends, and partner with cross-functional stakeholders to drive effective CAPA and continuous quality improvement initiatives.
• Contribute to global audit programmes, inspection readiness activities, SOP improvements, and risk-based quality strategies supporting complex international clinical development programmes.

Job description

I'm partnering with a leading multinational healthcare organization to appoint a Regional GCP Auditor to join its APAC Quality function. Reporting into a global R&D Quality leadership team, this position offers the opportunity to play a key role in strengthening clinical quality, inspection readiness, and GCP compliance across multinational clinical development programmes.

In this role, you will:

• Lead and execute GCP audits across investigator sites, Contract Research Organizations (CROs), vendors, E-system providers and Ethics Committees throughout the APAC region.
• Assess compliance with global GCP regulations including ICH E6, 21 CFR requirements and international clinical research standards, ensuring the integrity of clinical trial data and patient safety.
• Prepare comprehensive audit reports, perform risk assessments, identify compliance trends, and partner with cross-functional stakeholders to drive effective CAPA and continuous quality improvement initiatives.
• Contribute to global audit programmes, inspection readiness activities, SOP improvements, and risk-based quality strategies supporting complex international clinical development programmes.

What this opportunity offers:

• Regional APAC scope with up to 25% travel.
• Exposure to multinational Phase I–IV clinical development programmes.
• Close collaboration with global Quality and Clinical Development leaders.Long-term career development within an established international healthcare organization.

Professionals with GCP Quality Assurance and Clinical Auditing experience, particularly those with experience auditing investigator sites, CROs and clinical vendors, are encouraged to apply.

Professional Mandarin language capability is essential due to regular interaction with regional stakeholders and clinical partners across Greater China.