Pharmaceuticals Professional
Greater New York City Area
Pharmaceuticals Professional
Greater New York City Area
I am a Quality and Compliance professional with 17 years experience at a Director level in Pharmaceutical QC/QA. My experience encompassed FDA regulated and international organizations at headquarters, regional, and plant levels.
My areas of expertise include FDA Compliance, Strategic Planning, Directing Diverse Organizations, Quality Systems, Risk Management, cGMP’s, Validation, Laboratory Management, Auditing, Training, and Leadership Development
(Public Company; 10,001 or more employees; BMY; Pharmaceuticals industry)
January 2005 — December 2006 (2 years )
Responsible for supporting the strategic development and execution of the Worldwide auditing plan. Quality and Compliance representative on the Business Risk Management Team, Business Development Team and Global Sourcing Tactical Committee.
(Public Company; 10,001 or more employees; BMY; Pharmaceuticals industry)
January 2003 — January 2005 (2 years 1 month)
Responsible for directing all Quality and Compliance activities in the Latin America Region including QC/QA organizations in six manufacturing plants and three business groups
(Public Company; 10,001 or more employees; BMY; Pharmaceuticals industry)
January 2002 — January 2003 (1 year 1 month)
Responsible for establishing and directing the Quality and Compliance activities for the business and external manufacturing strategies, DEA compliance and Automated Systems Quality Assurance.
(Public Company; 10,001 or more employees; BMY; Pharmaceuticals industry)
January 1999 — January 2002 (3 years 1 month)
Responsible for directing the consumer products quality and compliance programs throughout the International operations. BMS-Lion Japan and UPSA France Quality and Compliance organizations reported to the position.
(Public Company; 10,001 or more employees; BMY; Pharmaceuticals industry)
January 1998 — January 1999 (1 year 1 month)
Responsible for directing the New Brunswick Quality Control Laboratories and Quality Assurance supporting the BMS Parenteral Operations, and the North America Quality Assurance Group.
(Public Company; 10,001 or more employees; BMY; Pharmaceuticals industry)
January 1994 — January 1998 (4 years 1 month)
Responsible for directing the "Center Led" World Wide Validation Group.
(Public Company; 10,001 or more employees; BMY; Pharmaceuticals industry)
January 1993 — January 1994 (1 year 1 month)
Responsible for directing the operations of World Wide Environmental Validation and Compliance, World Wide Microbiological Technology and Compliance, the New Brunswick Environmental Control Department, and the radiation safety Health Physics Department.
(Public Company; 10,001 or more employees; Pharmaceuticals industry)
January 1989 — January 1993 (4 years 1 month)
Responsible for directing the Environmental Control, Microbiological Control, Biological Control, and Radiation Safety Departments.
1965 — 1969