A results driven leader with twenty one years quality assurance and regulatory experience in the global pharmaceutical industry. Broad based, early experience with United States Food and Drug Administration provided hands on exposure and in depth technical knowledge across multiple regulated commodities. Areas of expertise include parenteral and solid dosage form pharmaceuticals, fractionated biologics, in-vitro diagnostics, medical devices, human plasma for sourcing, human tissue for transplantation, and bioresearch monitoring. Proven ability to analyze systems, identify gaps, and formulate and execute cross functional, cross regional, solutions to enhance business efficiencies and compliance.Specialties: Global quality and regulatory compliance to include GCP,GMP, GPvP, ICH, EU Directive.