Senior level clinical operations program quality, compliance and operational excellence executive with more than 20 years of progressive Clinical Operations leadership experience spanning roles from CRA through Vice President, followed by more than 12 years experience in Clinical Quality, Compliance, Operational Excellence, Integrity, risk management/mitigation and Inspection Readiness for both global and start-up biotechnology and pharmaceutical organizations, Ph I-IV. Vast experience partnering cross-functionally with all R&D disciplines as well as Legal, Senior Leadership, KOLs and Health Authorities. Proven expertise in compliance program development, Regulation & Guidance interpretation, internal investigations, risk-based quality management and monitoring aligned with ICH E6(R3)/GCP/GPV/GLP, and 21 CFR (including Parts 312, 50, 56 and 11) quality metric analysis and signal detection for risk mitigation and quality improvement. Recognized as an SME for ICH/GCP as well as for the ability to translate complex regulatory and legal requirements into practical, business-oriented guidance across all clinical programs and deliver impactful training and problem-solving strategies to staff and senior leadership.
