- Proven record of delivering multi - million-dollar projects for new system implementations and existing system enhancements.
- Excels at defining overall strategy and diving hands-on in the details to complete program and project objectives.
- Applies knowledge of GxP to ensure system compliance with governmental and business regulations.
- Built cross-functional teams into cohesive, high-performing units that delivered exceptional value.
- Strength in coordinating all aspects of product development from concept to delivery, exceeding schedule, budget, scope requirements and business objectives.
- Project Management
- Computer System Validation
- Business and Systems Analysis
- System Integration
- Manufacturing Execution System
- Team Collaboration
- Project Budgeting
Languages: C# | VB | SQL | HTML | CSS | .NET
Databases: MSSQL | MySQL | Oracle
Software: MS Project | JIRA | MS Office | LabVantage LIMS | Visual Studio | TFS
Concepts: Agile| SCRUM | Waterfall| UAT | Unit Testing
Confidential, Westborough, MA
- Managed deployment of the Serialization system to 5 Confidential sites, enabling sites to become compliant with Food and Drug Administration (FDA) Track and Trace regulations. Upgraded Data Analytics capability at the Allston site by implementing APEX Data Analytics system that captures, monitors and trends critical production data.
- Designed Agile governance and deployment models for Serialization and APEX projects, standardizing deployment process and providing means for collaboration across sites.
- Organized and produced GxP ITS deliverables, ensuring system compliancy with Confidential ’s Unified Project Methodology and Federal regulations.
- Partnered with global teams to design, deploy, and validate IT infrastructure across sites, securing redundant systems that satisfy industry regulations.
- Managed development of integration points with systems (TIBCO, SAP), stabilizing communication and data transfer between applications.
- Led cross-functional teams in RFP creation and vendor selection for Manufacturing Execution System(MES) allowing the business to develop framework for MES implementation at a new manufacturing facility.
- Created and managed project risk register, educating management on potential issues and developing mitigation plans to address forecasted issues.
- Prepared and distributed status presentations for senior leadership teams, facilitating business strategy decisions.
Confidential, Aliso Viejo, CA
Senior IT Project / Implementation Manager
- Worked in partnership with operational and financial teams in developing, prioritizing, and maintaining implementation strategy, and project budget.
- Navigated project team through GE’s Tollgate process, coordinating with stakeholders across larger GE organization, ensuring global project support and approval.
- Analyzed and implemented LEAN business process in BioPharma department increasing process and resource efficiency.
- Coordinated and produced GxP deliverables, validating the LIMS according to FDA 21 CFR Part 11 regulations.
- Lobbied executives, organizational leaders, and business partners, organizing project requirements, strategy and product features.
- Trained local and global system administrators, lab administrative assistants, and support resources, safeguarding personnel, can support future business requirements.
Confidential, Irvine, CA
Scrum Master / Project Manager / Consultant
- Owned and managed development of TPS and DataStream platform. Introduced systematic efficiencies that reduced time to create Title Insurance Products. Beta version of DataStream saved $200K in costs and projected to save $2M annually when fully implemented.
- Administered TPS (Title Production System) and DataStream product backlogs, deploying enhancements, and resolving system, and workflow issues.
- Synchronized 20-person development team to 90% efficiency rates, delivering projects and functionality on time, in scope, and within budget.
- Introduced product features automating business processes, reducing production costs significantly and increased operational efficiencies.
- Provided cross-functional leadership and coached development team, business analysts, and product managers on SCRUM and best practices, improving team performance.
- Facilitated Sprint Planning, Daily Stand Up, and Retrospective meetings, clarifying project and team objectives in given sprint cycle.