Experience

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  Compliance Management Consulting

  • President

    • 2000 - Present

    Independent consulting firm providing expert witness, regulatory vulnerability assessments and compliance management consulting services to the FDA-regulated industries.Compliance Management Consulting provides a wide range of regulatory compliance and quality-related services to food, pharmaceut...

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  Quintiles Consulting

  • Vice President

    • 1996 - 1999

    Manages and directs Quintiles Consulting in the delivery of expert quality and regulatory services to the biomedical industrySupports clients in planning, developing, and implementing quality and regulatory systems to assure compliance with U.S., European, and Pacific Rim requirements for GLP, GC...

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  Quintiles Quality Regulatory Alliance, Inc. for...

  • President & Chief Operating Officer

    • 1994 - 1996

    Directed the Quality Systems Division for global corporate BRI activities (products, services, contracts, internal procedures, and ISO 9000/Quality Systems Standards); oversaw GLPs, GCPs, GMPs, and Good Design Practices consulting, training, and/or auditing for clients; acted as Inspection Coordi...

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  FDA Northeast Region, Boston MA

  • District Director, New England District Office

    • 1987 - 1994

    Provided executive direction to FDA's consumer protection and enforcement programs throughout New England; managed staff of more than 100 compliance officers, investigators, inspectors, engineers, and analysts responsible for enforcing the Food, Drug, and Cosmetic Act;Led Boston District to d...

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  FDA Center for Devices & Radiological Healt...

  • Director, Division of Compliance Programs

    • 1977 - 1987

    Responsible for the development and application of the 1978 medical device Good Manufacturing Practice RegulationsDeveloped and implemented the Guideline on the Principles of Process ValidationDeveloped and evaluated field compliance programs for in vitro diagnostic devices, sterility, foreign de...

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  FDA Bureau Of medical Devices, Silver Spring MD

  • Special Assistant to the Director, Office of Compliance

    • 1975 - 1977

    Assisted the Associate Director for Compliance in device recall and case management, diagnostic product and medical device regulatory guidance, medical device surveillance, and industry education programs

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  FDA, Rockville MD

  • Executive Development & Management Intern Program

    • 1970 - 1975

    Developed strategic plans for medical device legislation; prepared FDA's medical device forward plan and budget, evaluated industry self-inspection pilot initiatives

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  FDA, Boston MA

  • Food and Drug Inspector, Boston District Office

    • 1966 - 1969

    Responsible for inspecting food, drug, device, and veterinary medicine manufacturers for compliance with applicable laws; inspections focused on microbiological problems, seafood safety, and product safety