An accomplished quality and regulatory leader with a history of creative innovations in pharmaceuticals, medical devices, diagnostics, and life sciences. Demonstrated ability to implement global quality systems, cultivate team partnerships, and establish harmonized best practices known to embrace dynamic environments, challenge the status quo, and present new solutions creating value for companies and their stakeholders.20 years plus as a quality/regulatory professional with focused efforts on global quality systems, risk management, regulatory compliance, design assurance, auditing training, improvements, harmonized practices, product quality, and patient safety.• Passion for Excellence and Results Driven• Strategic Planning, Direction and Execution• Consulting, Collaboration, Partnership and Teamwork• Budgeting, Leadership, and Time Management• Technical and Communications Skills• Risk Management and Problem Solving Skills• New Product Development Design Assurance• Implementation of Strategic and Quality Initiatives▪ Global Contracts and Negotiation Skills• Statistical Process Control Tools• Verification & Validation (V&V) process• Facility Qualification; IQ/OQ/PQ/PV• ICH, ISO 9001, ISO 13485, and ISO 14971• CGXP, Quality System Regulation (QSR), 21 CFR Part 210/211 and 21 CFR Part 11 • US DEA Quota/UN Imports/Exports/ARCOS Reporting • Corrective Actions and Preventive Actions, Deviations and Non-conformances• M.S. Office Suite, Trackwise, Netregulus, SAP, Mainsaver PM Software