Compliance Manager - APAC
Core
Manage GxP audits and regulatory authority inspections for the company, investigator sites, and clients across the APAC region.
Role type
Senior Compliance Manager (GxP/Audits)
Builds
Audit readiness, inspection support, and compliance frameworks for clinical research programs
Domain
Life Sciences / Clinical Research / Regulatory Compliance
Deliverable
client delivery
Required skills
GxP knowledge, GCP expertise, regulatory framework understanding, root cause analysis, risk assessment, CAPA development, audit facilitation, process improvement, mentorship
Preferred skills
Management/leadership experience, Veeva QMS proficiency, Biology or Pharmacy background
Technologies
Microsoft Office Suite, Veeva QMS
Responsibilities
Provide consultation on GxP audit and inspection readiness; serve as primary contact for audit discussions; support client audits and regulatory inspections including risk assessment and mock interviews; lead and approve audit reports; investigate root causes of non-conformances and develop CAPAs; develop compliance guidance and training materials; lead process improvement initiatives; mentor staff; present audit findings at meetings
Seniority
Senior, hands-on IC with leadership responsibilities
