QA Auditor III to QA Manager
Core
Conduct and lead GCP audits, regulatory inspections, and site/vendor audits to ensure clinical trial compliance and quality standards.
Role type
Senior GCP Quality Assurance Auditor / Manager
Builds
Regulatory compliant clinical trial operations and audit reports
Domain
Clinical Research / Life Sciences / GxP
Deliverable
client delivery
Required skills
GCP Auditing, Investigator Site Audits, GxP regulations knowledge, Root cause analysis, Risk assessment, Conflict management
Preferred skills
Vendor audits, Database audits, Clinical study report audits, Process improvement
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 to project teams; Lead process audits; Prepare and present audit findings at meetings
Seniority
Senior, hands-on IC with potential management responsibilities
