Results oriented and certified Project Management Professional with extensive experience delivering Quality IS projects.

Manage the Quality Information Systems Run Support Team providing incident response to high-availability production systems for global applications,including: the eCAPA Corrective Action Preventive Action and Global Complaints Systems Team also implements projects for these applications.

Program Manager for the eMDR program for BSC which provided the company compliance with the United States Food and Drug Administration’s (FDA) Medical Device Reporting (MDR) regulations and its standardization policy for the electronic filing and submission of MDRs through the FDA’s Electronic Submissions Gateway (ESG). . Project received the BSC Global CAPA Award 2010. Project Team received CIO Team Award 2010.

Other BSC Consulting Engagements o Corporate Toxicology - Latex, DEHP, and Sterilization Database - Performed analysis for a proposed web-based custom solution to collect, store and report Latex, DEHP, and Sterilization information to support requests for product information from internal and external customers. o Remediation of Project Documentation for Quality Hub and FDA Audits - Remediated project documentation to ensure system validation in preparation for Quality Hub Audits. o Global CAPA System Retirement Project - Developed and tested reports in preparation for GCAPA system decommission. Developed documentation for the System Administrator for data retention, system maintenance and audit purposes.o Global Corrective Action Preventive Action (GCAPA) – BA on the project team that deployed a pilot Pilgrim web-based application to automate the Corrective Action Preventive Action (CAPA) record. Pilot Sites: Miami, FL, Spencer, IN and Mt. View, CA. o Global eManufacturing Project - Manufacturing Execution System (MES) – Technical writer for the project team that deployed a CAMSTAR web-based system to automate the Device History Record on the production line system (Oracle database application and Business Objects reporting). System feeds/interfaces with the Training Records System, Product Documentation Management System (PDM) and SAP. Pilot Site: Cork, Irelando Training Records System (TRS) – Tech writer/trainer on the project team that deployed a CAMSTAR web-based system to automate employee training records at manufacturing sites. Training transactions were linked to Operator certifications on the production line. System feeds/interfaces with PeopleSoft, the Manufacturing Execution System (MES) and Product Management Documentation System (PDM). Pilot Site: Cork, Ireland.Global Complaints System Project (GCS1) – Change Management Lead on the project team that deployed a NetRegulus web-based complaint tracking system.

Program Management Office –Reported to Director of PMO. Responsible for in PMO related project planning activities. Reviewed internal SLAs, assigned project charge codes, performed QA and maintained project data in the PMO’s portfolio database. Prepared monthly portfolio and compliance metrics reports for senior management. Mentored Project Managers and Line of Service Account Managers in the use of project management tools and project methodologies.Project Manager - Experienced working with virtual project teams. Managed IS projects throughout the project lifecycle and maintained successful virtual and global team relationships while in the project management role.