Quality Auditor - GLP/GCP
Core
Ensuring clinical research laboratory testing operations comply with global regulatory standards and industry best practices through audits and compliance monitoring.
Role type
Senior Quality Auditor (GLP/GCP)
Builds
Compliance assurance for clinical research laboratory testing operations
Domain
Healthcare / Clinical Research / Regulatory Compliance
Deliverable
client delivery
Required skills
GLP/GCP regulatory knowledge, audit execution, CAPA plan creation, external audit hosting, regulatory compliance enforcement, quality metrics reporting
Preferred skills
Quality systems/standards expertise, strategic communication, project management, regulatory strategy influence
Technologies
ISO 15189, ISO 13485, CAP
Responsibilities
Conduct audits per activity table, contribute to global QA policies, support CAPA plans, host external audits/inspections, support QA-to-QA client relationships, deliver audit training, participate in global quality initiatives, report quality metrics and corrective actions
Seniority
Senior, hands-on IC
