Auditor - GCP

Role: GCP Auditor within Research & Development Quality, responsible for executing global audits to ensure clinical trial data integrity and regulatory compliance. Responsibilities: conduct audits of investigator sites, CROs, IRBs/ECs, and external vendors; prepare detailed audit reports, categorize findings by risk, and recommend corrective actions; analyze non-compliance trends and communicate risks to management; support SOP improvements and develop risk-based solutions for clinical trial oversight; stay current with global GCP regulations (ICH E6, 21 CFR Parts). Qualifications: BS in biological sciences or related field; 3+ years of GCP QA experience in clinical research; strong knowledge of clinical trial phases, monitoring, and regulatory frameworks; audit management skills; excellent interpersonal and negotiation abilities; proficiency with ICH E6, FDA regulations, and international directives. High-Value: clinical research, GCP compliance, audit management, regulatory knowledge, cross-functional stakeholder engagement. Work Setup: up to 50% travel; location flexible.