GCP QA Clinical Auditor II
Core
Conduct and lead GCP audits, regulatory inspections, and quality assessments for clients, internal teams, and vendors to ensure compliance and quality standards.
Role type
Senior IC Quality Assurance Clinical Auditor
Builds
Audit reports, compliance findings, and process improvement recommendations
Domain
Life Sciences / Clinical Research / Quality Assurance
Deliverable
client delivery
Required skills
GCP knowledge, regulatory compliance, audit leadership, root cause analysis, risk assessment, conflict management
Preferred skills
Vendor audit experience, database audit experience, clinical study report audit experience
Technologies
Computer software (in-house and off-the-shelf)
Responsibilities
Conduct client, internal, and GCP audits; perform site, facility, and vendor audits; provide GCP consultation; prepare and present audit findings
Seniority
Mid-level, hands-on IC