QA Compliance Senior Auditor, GCP -Central Lab Services
Core
Senior auditor ensuring regulatory compliance and quality assurance for central laboratory services, managing internal and external audits and inspections.
Role type
Senior QA Compliance Auditor
Builds
Compliance status for central lab operations and accreditation
Domain
Healthcare diagnostics / Laboratory services
Deliverable
client delivery
Required skills
GCP/GLP regulatory knowledge, internal audit execution, vendor audit execution, regulatory inspection hosting, CAP/ISO 15189 familiarity, SOP drafting, quality metrics reporting
Preferred skills
NMPA inspection support, client audit hosting, vendor audit hosting
Technologies
N/A
Responsibilities
Host regulatory inspections (e.g., NMPA), coordinate lab accreditation inspections (CAP, ISO 15189), conduct internal and vendor audits, contribute to global QA policies, provide regulatory interpretation expertise, deliver training to QA members, report quality metrics and implement corrective actions
Seniority
Senior, hands-on IC