Position:
Director, Therapeutic Area Clinical QA - Immunology & Established Products at Johnson & Johnson
Location:
Greater Philadelphia Area
Work:
Johnson & Johnson
since Jan 2009
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Director, Therapeutic Area Clinical QA - Immunology & Established Products
Johnson & Johnson
2006 - 2008
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Associate Director, GCQA
Johnson & Johnson
2004 - 2006
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Manager, GCQA
Johnson & Johnson
2002 - 2004
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Senior QA Specialist
Centocor
2001 - 2002
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Senior Compliance Specialist
Bristol-Myers Squibb
1999 - 2001
-
Compliance Auditor
PharmaNet
1999 - 1999
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Senior Regulatory Compliance Specialist
PharmaNet
1998 - 1999
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Regulatory Compliance Specialist
NYU Medical Center
1993 - 1996
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Research Project Coordinator
Memorial Sloan-Kettering Cancer Center
1990 - 1993
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Research Study Assistant/Study Coordinator
Education:
Rutgers, The State University of New Jersey-New Brunswick 1986 - 1990
BA, English and Psycology with Premed concentration
Skills:
Biotechnology, Clinical Research, Clinical Development, Quality System, Change Control, Quality Auditing, CTMS, IND, CRO, GCP, GMP, GTP, FDA, EMA, MHRA, Site Inspections, Pharmaceutical Industry, Clinical Pharmacology, Early Development, Small Molecules, Inspection, Auditing, Internal Audit, External Audit, Vendor Management, SOP development, SOP authoring, Sop, Operations Management, Leadership, Cross-functional Team Leadership, Team Leadership, Technical Leadership, GCP