MANAGEMENT PROFILE

A PMI certified Project Management Professional PMP with Six Sigma Green Belt training and ITIL v3 Foundations certification. Demonstrated strengths in leadership, cross-functional team management, relationship management, problem solving, team building, vendor management, motivating and directing people. Skilled at communicating, interfacing, and negotiating with individuals and groups across organizations ensuring unified service delivery to internal and external customers. Proven ability to deliver large projects/programs across multiple disciplines including Information Technology, Quality, Validation and business areas.

SELECTED CAREER ACCOMPLISHMENTS

• Program Managed the successful and timely completion of Merck's Global Product Registration Management Program aka GPRM/Orion. GPRM is a cross-divisional, enterprise-level program focused on the creation, use and maintenance of global product registration information. The program was implemented leveraging the Liquent InSight Regulatory Information Management RIM platform.
• Recipient of Pharmaceutical Sciences and Drug Metabolism 2008 Excellence Award in recognition of leadership contributions, dedication and commitment to Systems Improvement Quality Enhancement re-engineering initiative for the PharmSci Quality Tracking System PSQTS project.
• Recipient of Schering-Plough's Distinguished Contributors Award and numerous Shining Performance Awards for projects/programs delivered with exemplary actions which produced greater-than-expected results and had a measurable impact on Schering-Plough being released from the Food and Drug Administration's Consent Decree.
• Program Managed Schering-Plough Research Institute's Pharmaceutical Sciences Computer Validation initiative. Eighty three projects 113 systems successfully remediated for computer validation in 4.5 months vs. 24 months for previous program. Leveraged lessons learned from previous successes and delivered this critical program on-schedule, within specifications and under budget.
• Program/Project Managed the successful completion of Computer Validation Consent Decree requirements at the Las Piedras, Manati and New Jersey manufacturing sites. Program valued at over 90m for the 3 Consent Decree sites.
• Developed detailed project plans, which included critical path and dependency details, responsibility matrixes, communications plans, potential risks and contingency plans. Matrix managed personnel to achieve specific project objectives, project milestones and customer satisfaction goals. Initiated issues management processes, documented and tracked issues to closure.

PROFESSIONAL EXPERIENCE

Confidential

Associate Director, Project/Program Management,

Senior Project Manager / Program Manager,

• Program Managed the IT deliverables within the Planning, Development and Installation phases of the GPRM program. Managed leads across 8 IT workstreams Application Technical Architecture, Deployment Hypercare, Interfaces, IT Testing, Migration, Reporting, Requirements, and Systems Development Life Cycle . Extended team members included internal/external resources and onshore/offshore operations. Facilitated weekly Team Lead meetings to monitor progress against schedule and identify/resolve issues and risks. Chaired meetings with sponsors and IT/Business Workstream leads for program updates and proactive communication of potential escalations. Subsequently requested to PM the business User Acceptance Testing deliverables within the Acceptance phase.
• Established multi-million dollar capital/expense program budget, worked with suppliers internal/external on the monthly budget vs. actual analysis and forecast revisions.
• Leveraged BMC Remedy ITSM Change Management Console, HP Quality Center, and MSPS2010. Designed excel tracking tool that addressed HPQC reporting gaps in order to monitor system testing progress and facilitate closeout of Development and User Acceptance phase deliverables.
• Functioned as a Project/Program Manager supporting the Global Clinical Supply organization. Instrumental in delivering BioClinica Optimizer system and ELPRO Libero Temperature Monitoring Device Using PacknGo Software ELPRO to the GCS organization. BioClinica will provide Protocol level Clinical Supply Forecasting and Optimization capabilities and the following business benefits: reduction in trial costs better predictability of stock-outs, lost subjects, overage, and waste and baselined global supply requirements. ELPRO will provide Cold Chain tracking capabilities and improved compliance and shipping reliability at lowered costs.
• Program Managed the scoping phase of a Global Clinical Supplies initiative to harmonize Clinical Supply Information Management Systems across 5 sites and 3 divisions. Scoping phase objectives completed as scheduled. Deliverables included establishing a global harmonized business process, developing a business case and project budget to support the program and establishing a timeline for implementation.
• Successfully managed concurrent project teams in the configuration, testing and release of the PharmSci Quality Tracking System PSQTS. Initiatives included alignment of two business critical workstreams, Investigations and Change Management. Facilitated project team meetings, Steering Committee meetings and presented status/issues/mitigation plans weekly at the Senior Management Operational Oversight Committee VP level. Both modules were delivered on-time, under budget and in-line with customer expectations. The Change Management module resulted in 82 reduction in approval cycle time, a 16 increase in Right First Time rate and On-time change approval consistently >90 .
• Functioned as the Customer Relationship Manager between the PharmSci business unit and IT. Interfaced with PharmSci Senior Managers to review business priorities, health of application and project portfolios and operational excellence metrics. Maintained the PharmSci Information and Technology Plan with yearly updates based on business priorities.
• Created and led a cross-functional team consisting of 70 resources. Cross-functional project team comprised of resources from across 11 disciplines. Resources structured into 13 project teams led by 7 Project Managers. Presented program status weekly to Pharmaceutical Sciences Compliance Governance Council Meeting VP and directs level. The program was delivered in-line with the aggressive Consent Decree timeline 4.5 months , under budget and with significant leadership accolades from Senior Management. Promoted to D-1 level at conclusion of the program.
• Led the Consent Decree remediation effort for New Jersey's Quality Assurance System, a laboratory Information System used to manage and document testing results for the subsequence release of manufactured pharmaceutical product. Reorganized the 20 member cross-functional team into a high-performing team and delivered the remediation effort on-schedule thereby ensuring that the site met its Consent Decree commitments.
• Provided Program Management direction and leadership to the Las Piedras and Manati manufacturing facilities in support of their FDA Consent Decree commitments. Mentored the sites in the utilization of Project Management best practices in support of the program. Operated on-site and collaborated with Senior Site Management. Established program guidelines, communication protocols and risk/mitigation strategies. Implemented a lessons learned program for remediation that was leveraged across other SP Consent Decree programs.
• Developed a Work Breakdown Structure that aligned with Schering-Plough's Consent Decree commitments to the FDA. Facilitated the development and utilization of a Program Tracking / Reporting Tool used to track the progress of the Computer System Validation CSV / Part 11 Program. The tool identified gaps in program requirements and was utilized by Site Project Managers to develop/maintain their remediation project schedules and track their progress.

Confidential

Administrative Officer,

• Reviewed the company's System Development Lifecycle SDLC process and made recommendations on methods to improve the process. Established a directory of enterprise wide Project Management processes / methodologies to streamline life cycle deliverables. The objective was to increase the utilization of the structured methodology thereby delivering projects which would lead to increased customer satisfaction, more efficient new product development and implementation, and cost reductions.
• Performed monthly assessments on the IT Project Portfolio which consisted of 120 projects and reported to Senior Management on the health of the portfolio. The assessments included reviewing Status Reports and Project Plans for each project, focusing on proactive escalations of potential risks and addressing those areas with the respective project managers.
• Edward J. Quinn, MS, PMP Page 2 of 3

Confidential

Project Manager,

Established a change/release management process whereby projects were bundled by functional area. Implemented processes to align functional areas and improve quality and delivery metrics. Specifications were reviewed by cross-functional teams and implemented post a formal development, integration and QA process. Acquired stakeholder approval at appropriate milestones to ensure agreed upon deliverables. This new process resulted in higher quality deliverables and a reduction of 30 in development and test time. Chaired weekly cross-functional Product Line Management meetings where requests for new features/functionality and content were reviewed and prioritized. Communicated with stakeholders on project status and addressed change management requests.

Confidential

Project Manager / Relationship Manager

• Managed a 35 member, cross-functional project team to consolidate and upgrade Prudential HealthCare's PHC three national Dental Service Centers. Project included upgrades to the following technologies: voice, desktop, network and real estate components. Service Center capacities exceeded 1,370 seats total budget was 9.4 million.
• Functioned as the Relationship Manager between Prudential's infrastructure provider, Corporate Technology Services IT and PHC's Application Development operation, specifically, Marketing and Finance. Coordinated and facilitated planning sessions across the entities and negotiated project priorities based on business requirements and resource availability.
• Developed and managed a process to notify the Business and IT executives of Infrastructure or application problems that impacted the business. Chaired weekly meetings with the executives and service providers to review problem description, problem resolution, corrective actions and impact to the business. Participated in Problem Management and Post Mortem reviews, facilitated lessons learned sessions and worked with colleagues to implement accordingly to reduce the likelihood of repeat events.
• Initiated and managed a process improvement team chartered with increasing the reliability of application availability post installation. Developed a Model-Office Site process, which increased the reliability and distribution of Client Server applications by 45 . Employed a common approach to packaging, integration testing, end-user management and application distribution.

Confidential

Project Manager,

• Managed cross-functional project team Marketing, Finance, Technology and Sales to research, analyze and author a detailed Market Plan which outlined Global Information Management and Movement activities, Product Offerings, Worldwide Opportunity Analysis, Market Segmentation, and Market Share position.
• Established a Competitive Analysis organization chartered with performing competitive assessments and developing/updating competitor profiles in the Submarine Cable industry. Analysis included identifying the strengths, weaknesses, tactics and strategies of the competition. Tracked competitive presence worldwide and identified the development of Regional Trading Alliances worldwide. Prepared monthly income statements for the Consumer Products division and analyzed significant variances from budgets. Delivered executive level presentations on monthly results.