SUMMARY

• Project Manager, 18+ years, end - to-end experience bringing portfolio of projects to success with solid leadership, interpersonal knowledge, skills, and communication abilities for delivering worldwide enterprise projects with globally distributed teams (3-14). I am accomplished driving project delivery, managing resources, performing risk assessment, resolving deviations, maintaining budget, scope, change control, quality, time requirements and FDA GxP, EU ISO regulatory compliance.
• Detailed and results oriented, business and customer focused, I am a self-starter who takes charge and is accountable from project initiation, up-thru the efficient execution and launch of deliverables, on time within budget, compliant with company's business objectives and elements critical to quality. Strong working knowledge of the PDLC and SDLC, utilizing Waterfall to Agile practices for COTS and Custom implementations, and Stage-gate process for driving new R&D products to market. comfortable interacting with both business and technical minded colleagues. Ability to graspthe business and economic issues, develop the best solution and translate that analysis into executable programs with defined goals and objectives that tie all involved parties together
• Stage Gate NPD; Time To Market (TTM), Six Sigma, SEI CMMI (Capability MaturityModel Integration), Microsoft Solution Framework (MSF), Rational Unified Process (RUP), Agile Scrum, Waterfall, (PMI PMP in process), Good Automated Manufacturing Practice (GAMP5) as it applies to FDA software validation of Automated Systems and Risk Based Approach To Computer Validation. Identity & Access Management (IAM)
• Wide Breadth of Experience in a wide range of environments: Enterprise wide client-server applications; multi-tiered /N-tiered WEB software; ERP, JDE, IQMS, SAP, SAAS migration, shrink-wrapped (COTS) software products; Embedded board PC applications, Citrix hosted applications, and custom software solutions.
• Developed multiple approaches for testing of components. Moved theValidation group from a manual test environment to an automated HP QuickTest Professional (QTP); SilkTest / SilkPerformer and WinRunner / LoadRunner environment to improve the effectiveness of the testing methods by recognizing and respecting the unique competencies of others and by activelistening and exchanging information to work co-operatively and meeting mutual goals. Capacity to manage challenges and keep the communication going between all relevant stakeholders manages multiple levels of internal Projects Managers, and contract projectmanagement staff in delivering the global project portfolio. Ensures appropriate controls, processes, practices, and technologies were implemented to accomplish our defined goals. Accountable for adhering to PMO process, charter, resource forecast and financial forecast of the projects. Creation of Responsible, Accountable, Consulted, and Informed (RACI) matrix; Work Breakdown Structure (WBS)

AREAS OF EXPERTISE

• Project Management
• Program Management
• Transformational Change Strategy & Execution; Risk Analysis & Mitigation; Business Process Redesign
• SDLC
• PDLC
• Vendor Selection
• Business process outsourcing (BPO)
• Waterfall to Agile Scrum; Rational Unified Process (RUP); Time to Market (TTM); Design Analysis
• Code Review

TECHNICAL SKILLS

• QTP, HPQC, SAAS migration, COTS, EDI, ERP SAP, IQMS, JDE, CRM, EMEA, SQL ETL DTS, ERES FDA 21CFR11
• Good Automated Manufacturing Practice (GAMP5), FDA Quality System Regulation (QSR) 21CFR820, IEC 62304, FMEA, HAZOP and Fault Tree Analysis, New Product Development (NPD), Enterprise Content Management (ECM)
• IT PMO, PgM, SOW, RFP, RFQ, ROI, Gantt Charts, Risk Based Testing (RBT), Test-Driven Development (TDD). Six Sigma, CMMI, TTM, MSF, RUP, Waterfall to Agile Scrum, TDD, RAD, GAMP5, PMBOK, JIRA, Top Team
• Validation, FDA, 21CFR11, 210, 211, 820, ERES, IAM, GxP, ISO9000, IQ, OQ, PQ, DQ, CSV, UAT, FAT, SAT, CTP, PV, 21CFR820, ISO13485, ASTM E2500, EDI, HIPAA, ICH Standards E2B HL7 ICSR, ICD

PROFESSIONAL EXPERIENCE

Confidential

Consultant / Sr. Project Manager

Responsibilities:

• Managed portfolio of R&D projects utilizing Stage Gate process (Discovery, Scoping, Building Business Case, Development, Testing, Validation, Launch) for end-to-end project management. Proven ability to think strategically, act tactically and work effectively with sales & marketing, business & systems personnel. Facilitates interim meetings, evaluates risk analysis, and project post mortems
• Oversight of multiple tracks for business, quality, technical resources used for delivery of solutions to support business needs and requirements. Develop implementation plans that include analyses such as cost-benefit or return on investment (ROI). Agile Scrum, JIRA, Confluence, Top Team, Enterprise Content Management (ECM)
• Project Management COTS selection, implementation, modification, migration and execution to ensure adherence to budget, schedule, and scope. Develop and update project plans for objectives, technologies, systems, information specifications, schedules, funding, and staffing. Monitor and track project milestones and deliverables. Confer with project personnel to identify and resolve problems. Develop and manage work breakdown structure (WBS) for Project deliverables, ensuring adherence to time, budget and quality standards. CSV, IV&V
• Ensure a consistent and timely project delivery. Direct and coordinate activities of project personnel and prepare project status reports for sponsors and stakeholders. Establish and execute the project communication plan. Assign duties, responsibilities, and span of authority to project personnel. Schedule and facilitate meetings. Initiate, review, and approve modifications to project plans. Perform risk assessments to develop response strategies. Monitor the performance of project team members, providing and documenting performance feedback
• Negotiate with project sponsors, stakeholders and suppliers to obtain resources and materials. Identify need for initial and supplemental project resources. Coordinate recruitment and selection of project personnel. Identify, review, or select vendors and consultants to meet project needs. Develop and manage budgets for projects. Assess current or future customer needs and priorities through communicating directly with customers
• Waterfall to Agile Scrum Methodology with Daily Meetings, Acceptance Testing, Grooming, Velocity, User Story, Impediment, Effort Estimates, Task Board, Backlog, Release Planning, Iteration Planning, Burn Down Chart, TDD. Define project and operational metrics, key performance indicators (KPI), Critical to Quality (CTQ) and Stage-gate process for driving new R&D products to market

Confidential

Sr. Consultant / Project Manager, Business Analyst

Responsibilities:

• Reduced the overall development and validation cycle time 30%, enforcing consistency without changing the business process with Unifying Communications (UC), utilizing SharePoint to facilitate the paperless recording of the actual results during execution of GxP validation test scripts in lieu of manual documentation processes
• Improved efficiency by process mapping and analyzing the validation and development process, and implementing new electronic Unified Communications, workflows, templates and training of the work streams to the enhanced electronic validation process. RAID log (Risks, Assumptions, Issues, Decisions). Identity & Access Management
• Major Upgrade and Global Implementation of JDE EnterpriseOne (E1) supporting the company's business processes in Accounts Payable, Accounts Receivable, General Accounting, Fixed Assets Manufacturing Accounting, Customer Service and Warranty Management, Warehouse Management, Warehouse Shipping, Finished Goods Procurement, Requirements Planning, Supply Chain, Inventory Management, Forecasting, Sales Order Management, Sales Compensation and Customer Management. Business Acquisition Integration & Migration, WMS, IAM
• Web technology, the E1 system is accessed using secure remote connectivity using standardized clients. This JDE program is focused on consolidating operations onto a single ERP platform comprised of EnterpriseOne, Manugistics, Precision/TRAX, Partner, Vertex, and other applications hosted in the Data Center
• Full range of Project Management, NPD, validation, test execution activities, white box, black box, functional, end-to- end, regression, enterprise content management (ECM); data migration using ETL DTS; user acceptance, and cross application testing with summary reports and recommendations to the management teams on ways to best achieve action items; IV&V; CSV, NPD, Stage Gate, TTM, Agile, Scrum, JIRA, Confluence

Confidential

Sr. Project Manager / Change Control Manager

Responsibilities:

• Reduced the small NPD cycle time by 35% by modifying the existing PDM processes and simplifying existing project templates. Adept at handling portfolio of projects, concurrently and with tight deadlines. Proven experience in supply chain activities, people management, strategic planning, risk management, and change management
• Expert SDLC and advanced software knowledge within a FDA regulated industry. Web technology, strong problem solving and analytical skills, ability to analyze complex technical problems and translate that analysis into executable programs with defined goals and objectives that tie all involved parties together
• Stage Gate System, Computer System Validation (CSV), Global IT Governance of Quality, Compliance, and Software Validation ensuring overall quality both GxP and non-GxP for all NPD applications and software
• Experienced creating project plans, schedules, developing requirements, specifications, unit testing, functional testing, regression testing and implementation required SDLC validation documentation. Skilled using project management tools, resource costing, earned value, cost to complete, work breakdown structure
• Collaborating with peers in the definition of project and operational metrics, Gantt chart, key performance indicators (KPI), ensuring a consistent and timely delivery, and facilitating detailed project statuses, post implementation reviews, lessons learned and in makings process improvement recommendations
• Managed cross-departmental teams and driving completion of tasks. Utilized Lean, Agile Scrum methodology, establishing plans, milestones and communication plans for managing small / medium size teams
• Tracking and communicating progress of teamwork assignments against milestones. Attending and participating in management level project meetings and encouraging cross-functional team relationships. Driving and participating in NCEP and eCAPA investigation and closure processes. IV&V; Identity & Access Management
• Management of a team across various disciplines including master data management, request for pricing from vendors, coordination of workflow and business analysis efforts, developing scope statements, project plans, issue tracking documentation, status reports and other required regulatory documentation
• Agile Scrum Methodology (Scrum Daily Meeting, Acceptance Testing, Iteration, Velocity, User Story, Impediment, Effort Estimates, Task Board, Backlog, Release Planning, Iteration Planning, Burn Down Chart, Test-Driven Development (TDD). RAID log (Risks, Assumptions, Issues, Decisions); JIRA, Confluence
• Selection, Implementation & Migration of commercial off the shelf software (COTS), adding new functionality to existing COTS systems. Business Acquisition Integration & Migration

Change Control Manager

Confidential

Responsibilities:

• Facilitating CCB meeting, providing technical oversight, and accountable for approving all requested software/hardware changes or additions. System criticality assessment (SCA), risk/impact assessments, Identity & Access Management; Engineering Change Request (ECR), Engineering Change Order (ECO), Manufacturer Change Order (MCO), Document Change Order (DCO); performing ROI, prioritizing change requests
• Approving and prioritizing all site change requests, performing risk base assessment, reviewing the intended use to determine regulatory requirements for all additions or changes ensuring compliance with regulatory requirements and documented policies

Confidential, Cambridge, MA

Sr. Consultant / Sr. Project Manager

Responsibilities:

• Led the project teams on complex multi-product portfolio of global deliverables
• Full range of NPD, SDLC, Project Management, SW Development, R&D data migration using ETL DTS, Computer System Validation (CSV), Software Validation and Test execution activities, IV&V; Master Data Management (MDM), traceability matrixes, white box, black box, beta, functional, regression, integration, user acceptance, and cross application testing including manual and automated testing for regression, capacity, load, and performance
• Facilitated stage gate design reviews, interim meetings, risk analysis and project post mortems with summary report that identified successful and unsuccessful project elements. Web technology, guided and led the product development team (PDT) from product inception through the rollout for a portfolio of deliverables
• Established stage gate release plans for releases between development, testing, validation, and production. Analyzed products to identify testing, validation needs and staffing requirements
• Created project plans, Gantt charts, scheduling of tasks, dependencies, resources requirements for the successful completion of project goals and objectives on time within budget to the satisfaction of business owners. Developed solutions with defined goals and objectives that tie all involved parties together
• Biomedical Operations, BMRA-IT for the Clinical Pharmacy Research Services (CPRS) and master data management (MDM); JIRA, Confluence, Agile, Scrum. Selection, Implementation & Migration of commercial off the shelf software (COTS), adding new functionality to existing COTS systems. Business Acquisition Integration & Migration

Confidential, Waltham, MA

Sr. Consultant / Sr. Project Manager

Responsibilities:

• HIPAA compliant Electronic Data Interchange (EDI) transactions, supervising, testing and validating the implementation of an Electronic Health Record for Confidential 's Liberty health product offering for Coordination of Benefits (COB) for Medicaid and Professional Medical health claims processing for inpatient & outpatient (HIPAA, HITECH)
• Ensured the data was being mapped correctly from the TCFF (flat file) to the new X12N4010A1 file by validating all data elements, including situational data elements, and composite data elements within the loops and segments of 004010X091A1 for 835 remittance, 004010X096A1 for 837 Institutional claims for inpatient & outpatient including Coordination of Benefits (COB) for Medicaid and, 004010X098A1 for 837 Professional claims (Medical claims), and 997 functional acknowledgment for 837 transactions. IAM; Enterprise Content Management (ECM), CSV
• Hands-on, creation of the test center, validation strategies, priorities, resource requirements for the successful release of deliverables on schedule, on budget; IV&V; Agile, Scrum. Business Acquisition Integration & Migration
• Reviewed the proposed Accountable Care Organization (ACO) implementation requirements where payments are linked to reducing overall costs by using a sophisticated performance measurement for improvements in care

Confidential, Framingham, MA

Sr. Consultant / Sr. Project Manager

Responsibilities:

• Hands-on senior consultant for NPD engaged in overseeing off-shore testing and development efforts for validation of Staples' “Sign Solutions” enterprise application via 802.11 Wireless Request with Mobile printing, On Demand, with Overnight Batch Processes. Identity & Access Management
• Web technology, allowed individual Stores the ability to create signage that was wirelessly synchronized with the POS database, enforced Staples business rules, and provided the ability to author, configure, and create 2,000,000+/­signs per week with this new WEB signage application
• Approved test plans and detailed test cases to focus on end-to-end testing, black box testing, system integration testing, functional testing, and regression testing. Enterprise Content Management (ECM)
• Ensured that appropriate Stage gate practices were implemented including testing and validation was performed within the proper environments to accomplish our project goals and objectives on schedule

Technologies: NPD, Stage Gate, SOW, RFP, RFQ, ROI, SQA, SQE, CMMI, RUP; Agile, Scrum, J2EE, EJB, Java Servlets, JDBC, ActiveX; Apache 2x HTTP WEB server, BEA Web logic 7 Application and Admin server; Oracle 8x; HP-UNIX 11; Access via 3.5 PrintMe server running on IIS on Windows 2000; IBM WebSphere MQ Integrator 2.1, RPG ILE CL programs, and DB2 data store on AS400; Brio Data Reports 6.2 on Brio Reports SQR server and 802.11b Wireless networking, 802.11b wireless scanner and printing