Global IT QA e-Compliance Manager @ (April 2018 - April 2020)
SAP QA Cutover Manager @ (May 2015 - February 2017)
SAP Cutover Engagement Manager @ (May 2014 - April 2015)
SAP eCompliance Cutover Manager @ (October 2013 - December 2013)
HP ALM Validation Lead and SAP MES II Validation Lead @ (November 2012 - October 2013)
Senior Consultant @ (September 2012 - October 2013)
SAP QA Test Manager and Validation Lead @ (April 2012 - November 2012)
Quality System Remediation Advisor and Validation Lead @ (September 2011 - February 2012)
SAP QA Test Manager @ (February 2011 - August 2011)
Contractor @ (February 2011 - August 2011)
Contractor @ (February 2011 - August 2011)
Contractor @ (January 2011 - February 2011)
SAP RA and QA and Val Lead and Project Manager @ (January 2011 - February 2011)
Validation Engineer @ (March 2009 - January 2011)
Validation Consultant @ (January 2007 - December 2009)
Validation Engineer @ (January 2004 - December 2007)
Validation Consultant @ (January 2004 - December 2005)
Computer Lab Consultant @ (January 1999 - June 2003)
Mike Denton Education
Indiana State University
Chemistry and Business (Chemistry)
1997-2004
Mike Denton Skills
FDA
Six Sigma
Testing
ISO
Risk Management
Sarbanes-Oxley Act
User Requirements
Validation
21 CFR Part 11
Quality System
Quality Assurance
SAP
GxP
Computer System Validation
SDLC
Change Control
Management
Consulting
Process Improvement
Project Management
Cross-functional Team Leadership
Pharmaceutical Industry
Medical Devices
CAPA
SOP
SAP ERP
Microsoft Office
Change Management
CRM
Leadership
Document Management
GMP
Biotechnology
Software Documentation
Strategic Planning
U.S. Food and Drug Administration (FDA)
Business Process Improvement
Customer Relationship Management (CRM)
SAP Products
Software Development Life Cycle (SDLC)
Corrective and Preventive Action (CAPA)
ISO Standards
Customer Relationship Management Crm
Data Validation
ERP
Corrective and Preventive Action Capa
Cross Functional Team Leadership
u.s. Food and Drug Administration Fda
Sarbanes Oxley Act
Services
Software Development Life Cycle Sdlc
u.s. Food and Drug Administration
Customer Relationship Management
Software Development Life Cycle
Corrective and Preventive Action
Mike Denton Summary
Mike Denton, based in Miami Beach, FL, US, is currently a SAP Project Manager, Cutover Manager, Validation Manager at United Therapeutics Corporation. Mike Denton brings experience from previous roles at Duke Denton Consulting, Catalent Pharma Solutions, Gen Re and Boehringer Ingelheim. Mike Denton holds a 1997 - 2004 Chemistry and Business in Chemistry @ Indiana State University. With a robust skill set that includes FDA, Six Sigma, Testing, ISO, Risk Management and more. Mike Denton has 3 emails and 2 mobile phone numbers on RocketReach.
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