Frank Defazio
quality management, regulatory compliance, innovation, and change leader
- Role
- Vice President, Global Post-market Surveillance & Compliance Qa Ra at Insulet Corporation
- Location
- Worcester County, MA, US
- LinkedIn followers
- 500 followers
About Frank Defazio
Personal Overview:Help organizations and people get better at what they do.Proven leader of Quality, Regulatory Compliance, Change & Program Management.Passion for process, product, and service innovation.Adept at leading distributed teams across cultures, locations, functions, and levels.25 years of demonstrated success improving organizations, processes, and products in the Medical Technology/Life Sciences Industry from start-ups to multinationals (including Fortune 500 companies) across a wide range of technologies and indications.
Experience
Vice President, Global Post-market Surveillance & Compliance Qa Ra
Mar 2022 — Present
Global Head of Product Monitoring. Oversee people, processes, and technologies related to post-market surveillance and post-market compliance/quality assurance enterprise-wide for Insulet products globally. PRRC for PMS and Vigilance. Served as interim/acting head (as an independent consultant) from Nov 2021-Mar 2022 (see below).
Education
UMass Boston
Bachelor's, Ethics and Philosophy
Boston University
Master's of Science, Management (Business Continuity, Security & Risk Management)
Massachusetts Bay Community College
Associate of Arts - AA, Liberal Arts and Sciences/Liberal Studies
Harvard Business School Online
Certificate: Disruptive Strategy with Clayton Christensen
Eastern University
Data Science
Cornell University
Certificate Plant-based Nutrition, Human Nutrition
UMass Boston
Critical & Creative Thinking/Education
Skills
- U.s. Food and Drug Administration (Fda)
- Iso 13485
- Quality Assurance
- Product Development
- Life Sciences
- Regulatory Intelligence
- Process Improvement
- Continuous Improvement
- Risk Management
- Corrective and Preventive Action (Capa)
- Regulatory Affairs
- Customer Service
- 21 Cfr Part 11
- Medical Devices
- Capa
- Acquisition Integration
- Quality System
- Quality Systems
- Cross-Functional Team Leadership
- Gmp
- Biotechnology
- Data Analysis
- Six Sigma
- Strategy
- Project Management
- Strategic Planning
- Management
- Project Planning
- Design Control
- Change Management
- Program Management
- Quality Management
- Change Control
- Validation
- Innovation Management
- Leadership
- Iso
- Business Process Improvement
- Sop
- Fda
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