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Michael Gemma Location
Fairfield, NJ, US
Michael Gemma Work
Practice Head, Managed Services @ (August 2014 - Present)
Quality Manager - Information Governance and Management, Development Informatics @ (November 2012 - August 2014)
Manager, Global Clinical and Pharmacovigilance Quality @ (November 2009 - November 2012)
Manager, Schering Plough Research Institute Validation Unit @ (August 2005 - November 2009)
Senior Consultant, Lims Sme @ (November 2001 - August 2005)
Vice President of Professional Services @ (April 1998 - November 2001)
Manager, Client Services and Administration Operations @ Iea/American Environmental Laboratory (February 1991 - April 1998)
Michael Gemma Education
William Paterson University
Bachelor Of Science
1986-1990
Wayne Hills High School 1981-1985
Michael Gemma Skills
Leadership
Auditing
Clinical Trials
Good Laboratory Practice Glp
SDLC
CRO
Cross Functional Team
Computer System Validation
GAMP
GMP
ISO
21 CFR Part 11
ISO 13485
GxP
CTMS
Biotechnology
Business Analysis
Change Control
Regulatory Affairs
Software Documentation
Vendor Management
Life Sciences
Validation
Quality Assurance
Corrective And Preventive Action Capa
Regulatory Requirements
Pharmacovigilance
Quality System
Lifesciences
V&V
Laboratory Information Management System Lims
GCP
Quality Auditing
Cross Functional Team Leadership
Clinical Development
Pharmaceutics
Document Management
U.S. Food And Drug Administration Fda
EDC
Management
Project Management
Standard Operating Procedure Sop
Quality Control
Pharmaceutical Industry
GLP
LIMS
CAPA
Computer System
FDA
Sop
Software Development Life Cycle Sdlc
Biopharmaceuticals
Good Laboratory Practice
Laboratory Information Management System
Corrective and Preventive Action
Standard Operating Procedure
u.s. Food and Drug Administration
Software Development Life Cycle
Michael Gemma Summary
Michael Gemma, based in Fairfield, NJ, US, is currently a Practice Head, Managed Services at Patel Consultants Corporation. Michael Gemma brings experience from previous roles at Novartis, Merck, Schering-Plough Research Institute and Pierce Professional Resources. Michael Gemma holds a 1986 - 1990 Bachelor Of Science @ William Paterson University. With a robust skill set that includes Leadership, Auditing, Clinical Trials, Good Laboratory Practice Glp, SDLC and more. Michael Gemma has 3 emails on RocketReach.
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