GLP/GCP Lead Quality Auditor
Core
Lead internal audit program execution for clinical research laboratory testing operations to ensure compliance with global regulatory standards (GCP/GLP, ISO 15189, ISO 13485) and industry best practices.
Role type
Senior Lead Compliance Auditor (Quality Assurance)
Builds
Internal audit programs, regulatory inspection readiness, and continuous improvement initiatives for clinical laboratory testing.
Domain
Healthcare diagnostics / Clinical Laboratory Services / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Internal audit program management, regulatory inspection hosting, CAPA implementation, audit reporting, team mentorship, risk-based auditing, quality management systems, compliance software proficiency
Preferred skills
Strategic communication with clients, process improvement leadership, training and development of internal auditors
Technologies
Veeva, Trackwise
Responsibilities
Plan and implement the internal audit program; Serve as primary host for internal audits and regulatory inspections; Document audit findings and develop detailed reports with actionable recommendations; Lead audit review meetings and collaborate with management to address compliance gaps; Provide training and mentorship for internal auditors; Support QA projects to uphold compliance standards.
Seniority
Senior, hands-on IC with leadership responsibilities
