Senior Consultant, GCP Compliance

Job Summary

Senior Consultant, GCP Compliance, is a full-time role for an experienced clinical quality professional who independently leads GCP quality and compliance engagements for clients, overseeing CROs and clinical vendors while ensuring programs meet regulatory standards.

Key Responsibilities

• Establish and execute sponsor oversight programs for clinical trials, including CRO qualification and performance monitoring
• Conduct and report GCP audits, including investigator site and CRO/vendor system audits
• Lead inspection readiness and provide quality input on regulatory submissions and interactions

Qualifications and Requirements

• Bachelor's degree in life sciences, chemistry, pharmacy, nursing, or related discipline; advanced degree preferred
• Minimum 10 years of experience in GxP-regulated environments, with at least 8 years in GCP
• Experience as a lead clinical quality auditor with a minimum of 25 GCP audits conducted independently
• Direct experience supporting FDA BIMO inspections or equivalent EMA/MHRA inspections
• Subject matter expertise in ICH guidelines and familiarity with eTMF and EDC platforms