Program Director, Quality Systems, Insulet
Rivier College, Nashua, NH, M.B.A. & Masters in CIS
University of Massachusetts, Lowell, MA B.S., Information Systems
An IT and Quality professional with experience in fast-paced pharmaceutical and medical device industries. Catalyst in implementing positive change, integrating new systems, and meeting regulatory compliance for quality systems. Team member for the FICSA (FDA and Industry Computer System Validation) team.
Implemented several ALM tools to support business directives and ERP implementations using several ALM tools including IBM Rational, Propel, Jira, HP ALM and Polarion
Using Polarion I was able to automate the CSV Methodology, R&D requirements risk reporting, Laboratory equipment and inventory management and periodic review as well as automating IT change control for system defects and enhancements all in the last 10 years and three companies.