全职 Regional GCP Auditor 工作, 薪水, Barrington James Federal Territory 公司招聘中 - Ricebowl

Regional GCP Auditor | APAC

Kuala Lumpur, Malaysia | Hybrid

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.

If you are based in Kuala Lumpur and are looking to further your career within a global R&D Quality environment, I would be delighted to have a confidential discussion on this Regional GCP Auditor Role.

CEI: R2090154 | Licence No.: 22S1313