Location:
4750 Pleasant Hill Rd, Memphis, TN 38118
Work:
Daiichi Sankyo, Inc.
Senior Consultant???????Global Regulatory Information Management Systems???????Qa-Csv at Daiichi Sankyo, Inc
West-Ward Pharmaceuticals
Jan 1, 2015 - 2015
Senior Consultant ??????? Global Quality Information Systems ??????? Audits ??????? Validation
Johnson & Johnson
May 1, 2013 - Dec 1, 2014
Lead Consultant ??????? It Computer System Validation ??????? Risk Management ??????? Compliance Review ??????? It Qa
Norwich Pharmaceuticals
Feb 1, 2010 - Apr 1, 2013
Department Manager ??????? Quality Assurance ??????? Regulatory Compliance ??????? Risk Management ??????? Validation
Bioclinica
Oct 2009 - Jan 2010
Senior Validation and Qa Consultant ??????? Project Management ??????? Qa Oversight ??????? Gxp Audits
Schering-Plough Research Institute
Dec 2003 - Apr 2009
Senior Compliance and Qa Consultant ??????? Clinical Research ??????? Commercial Operation ??????? Global Information Systems
Sgcrc
Dec 2003 - Apr 2009
Qa and Regulatory Compliance Consultant ??????? Quality Improvement Solutions ??????? Audits ??????? Validation
Education:
University of Maryland Baltimore County 2015 - 2017
Master of Science, Masters, Pharmacy
Old Dominion University 1990 - 1995
Bachelors, Electronics Engineering
University of Maryland
Master of Science, Masters
Skills:
Fda, Gmp, Quality Assurance, Sop, Validation, Pharmaceutical Industry, Capa, Computer System Validation, Quality System, 21 Cfr Part 11, Gxp, Regulatory Affairs, Quality Control, Change Control, Clinical Trials, Regulatory Requirements, Cross Functional Team Leadership, Quality Management, Consulting, Biotechnology, Medical Devices, Change Management, Project Management, Pharmacovigilance, Management Consulting, Csv, Regulatory Guidelines, Compliance, Risk Management, Fda Gmp, Regulatory Analysis, Regulatory Documentation, Regulatory Policy, Global Regulatory Compliance, Regulatory Communications, Standards Compliance, Internal Audit, External Audit, Auditing, Clinical Trial Analysis, Data Validation, Analytical Method Validation, Equipment Qualification, Biotechnology Industry, Strategic Consulting, Process Consulting, Consumer Health Information, Best Practices, Clinical Research, Commercial Operation
Interests:
Children
Weight Training
Musical Plays
Disaster and Humanitarian Relief
Mountain Biking
Travel
Arts and Culture
Tennis
Certifications:
Certificate of Completion For Modicon and Siemens Plc Hardware and Software
Gamp???? 5 Series: It Infrastructure Compliance and Control
Asq Pharmaceutical Gmp Quality Training Course
Fda's Clinical Investigator Training Course
Gamp® 5 Series: It Infrastructure Compliance and Control
