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Jim McCormack Location
Shenandoah Junction, WV, US
Jim McCormack Work
2011 -now Vice President, Life Sciences Compliance, Global Regulatory and Cyber Security Management @
2017 -2017 Retired @ Retired Life Science Compliance Executive
2005 -2011 Vice President, Regulatory Affairs and Compliance @ Charles River Laboratories International, Inc.
1997 -2005 Bioresearch Monitoring Program Coordinator @ U.S. Food and Drug Administration
1987 -1996 Chief, Swine and Poultry Drugs Branch, Division of Biometrics and Production Drugs @ U.S. Food and Drug Administration
Jim McCormack Education
Virginia Polytechnic Institute and State University
PhD (Neuroendcrinology)
1984-1987
Iowa State University
MS (Animal Nutrition)
1977-1980
Purdue University
BS (Animal Science)
1973-1977
Jim McCormack Skills
Regulatory Requirements
FDA
21 CFR Part 11
GLP
Regulatory Affairs
GCP
Electronic recordkeeping
Computer system validation
International Regulatory Affairs
Validation
CAPA
Change Control
Lifesciences
Quality Auditing
CRO
Quality System
Biotechnology
Pharmaceutical Industry
Quality Assurance
Sop
GMP
Medical Devices
Technology Transfer
Regulatory Submissions
Clinical Development
Quality Control
R&D
Quality Management
Laboratory
Clinical Trials
V&V
Drug Discovery
Hardware Diagnostics
Life Sciences
Cross-functional Team Leadership
Information Security
Sales
Regulatory
Compliance
Marketing
Network Security
Cross Functional Team Leadership
C++
Management
Research
Security
Jim McCormack Summary
Jim McCormack, based in Shenandoah Junction, WV, US, is currently a Vice President, Life Sciences Compliance, Global Regulatory and Cyber Security Management at IBM. Jim McCormack brings experience from previous roles at Retired Life Science Compliance Executive, Charles River Laboratories International, Inc. and U.S. Food and Drug Administration. Jim McCormack holds a 1984 - 1987 PhD in Neuroendcrinology @ Virginia Polytechnic Institute and State University. With a robust skill set that includes Regulatory Requirements, FDA, 21 CFR Part 11, GLP, Regulatory Affairs and more. Jim McCormack has 2 emails and 1 mobile phone numbers on RocketReach.
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