Auditor - GCP
Core
Execute global GCP audits of clinical investigator sites, CROs, and E-System providers to ensure clinical trial data accuracy and regulatory compliance.
Role type
Senior GCP Auditor (Quality Assurance)
Builds
Audit reports, risk categorizations, and corrective action plans for clinical research programs.
Domain
Clinical Research / Biopharmaceuticals / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GCP audit execution, risk categorization, trend analysis, SOP development, regulatory knowledge (ICH E6, 21 CFR), stakeholder negotiation
Preferred skills
Experience with EU Clinical Trials Regulation, analytical problem-solving, managing travel-intensive schedules
Technologies
ICH E6 (R3), 21 CFR Part 11, 21 CFR Part 50, 21 CFR Part 312, 21 CFR Part 812, EU CTR 536/2014
Responsibilities
Conduct external audits of clinical sites and vendors, develop comprehensive audit reports with risk categorization, identify non-compliance trends, support SOP improvements, maintain knowledge of global GCP regulations
Seniority
Mid-Senior, hands-on IC
