Compliance Manager - APAC

Overview

Manage GxP audits and Regulatory Authority inspections for the company, investigator sites, and clients, with primary focus on APAC.

What you'll do

• Consult project teams and clients on GxP audit and inspection readiness and follow-up activities.
• Lead and/or review complex internal and external audits and inspections to ensure compliance.
• Support client audits and GxP regulatory authority inspections, including risk assessment, mitigation, training, and mock interviews.
• Lead, review, and approve audit and inspection reports.
• Investigate root causes of findings/non-conformances and develop CAPAs; follow up on implementation and effectiveness checks.
• Develop and share guidance, reference information, and quality management system training materials.
• Develop tools to track compliance activities and analyze compliance trends.

What you'll need

• Bachelor’s degree or equivalent formal academic/vocational qualification.
• 5+ years of quality assurance experience to perform the role (or equivalent education, training, & experience).
• 1+ years of management/leadership role experience (preferred).
• Extensive GxP knowledge with GCP required.
• Experience with quality management systems and regulatory frameworks, including internal audits and hosting/management of client audits and regulatory inspections.
• Proven root cause analysis experience.
• Advanced proficiency in Microsoft Office Suite and compliance-related software; Veeva QMS experience is a plus.

Details

• Work schedule: Mon-Fri.
• Majority of work focused on APAC; inspection support in other regions also in scope.