GCP QA Auditor III
Core
Leads complex internal and external audits to ensure compliance with quality assurance processes, global regulatory guidelines, and client contractual obligations.
Role type
Senior IC Quality Assurance Auditor (GCP)
Builds
Audit reports and quality services for clients and internal projects
Domain
Life Sciences / Clinical Research / Quality Assurance
Deliverable
client delivery
Required skills
GCP compliance, root cause analysis, regulatory inspection leadership, process auditing, clinical study report auditing, vendor/sub-contractor auditing, risk assessment
Preferred skills
Mentorship, negotiation, conflict management, database auditing, sample results table auditing
Technologies
GCP guidelines, regional research regulations
Responsibilities
Conduct and lead client, internal, and GCP audits; Lead directed site, facility, vendor, and sub-contractor audits; Provide GCP consultation to project teams and clients; Prepare and present audit findings at meetings; Serve as a resource to operational departments; Mentor junior auditors
Seniority
Senior, hands-on IC
