Rachel is a Quality Assurance and Clinical Compliance leader with over 13 years of experience in FDA-regulated clinical research environments. As QA Lead and Senior Compliance Consultant at QACV Consulting, she provides strategic oversight of Quality Management Systems, GCP audit programs, CAPA management, and regulatory inspection readiness across global clinical operations.

Rachel has extensive experience conducting and overseeing risk-based GCP, GCLP, and bioanalytical audits across investigator sites, CROs, vendors, laboratories, and internal QMS functions. She specializes in data integrity, documentation compliance, deviation and CAPA oversight, and aligning quality systems with ICH, FDA, and EU regulatory requirements.