QA Auditor III to QA Manager
Core
Conduct and lead GCP audits, regulatory inspections, and quality assurance activities for clinical trials, including site, facility, vendor, and system audits.
Role type
Senior GCP Quality Assurance Auditor / Manager
Builds
Regulatory compliance and quality standards for clinical research projects
Domain
Clinical Research / Life Sciences / GxP
Deliverable
client delivery
Required skills
GCP auditing, Investigator Site Audits, GxP regulations knowledge, root cause analysis, risk assessment, impact analysis, process improvement
Preferred skills
Vendor audits, database audits, clinical study report audits, negotiation, conflict management
Technologies
Computer software (in-house and off-the-shelf)
Responsibilities
Conduct and/or lead client, internal, and GCP audits; Perform directed site, facility, vendor, and sub-contractor audits; Provide GCP consultation to project teams and clients; Lead process audits and participate in complex system audits; Prepare and present audit findings at meetings
Seniority
Senior, hands-on IC with potential management responsibilities
