SUMMARY:

An accomplished results oriented leader with 30 years IT project management experience in architecting and delivering technical solutions. Possess extensive leadership and technical experience across multiple industries and numerous global enterprise systems. As a proven professional with unparalleled collective experience, a seasoned veteran, mentor and an integral member of project management, partnering with stakeholders and cross - functional teams to facilitate solutions throughout the entire SDLC.

TECHNICAL SKILLS:

SOFTWARE: MS Excel, MS Word, MS PowerPoint, MS SharePoint, MS Project, HP Quality Center, IBM Rational (ClearQuest, RequisitePro, TestManager, Functional Tester, TeamTest Suite and Robot), Mercury (Test Director and Winrunner), Netman, TS2, TSO/ISPF, File-Aid, DB2/IMS, CICS and MS Access

ENVIRONMENT: / TECHNOLOGY e-Commerce, Web-Based Applications, Oracle, ETL, Data Warehouse, Data Mart, Axway Track and Trace, Systech, SAP (SAP ERP, AII, PI and OER), ARISg (ARISg AEGIS and ARIS Global’s Total Safety Suite (TSS)), Documentum, Confidential Flex/Flash Builder, Eclipse, Juno, JBoss 5.1, Rally, Citrix, DB2/IMS databases, Java, C##, Visual Basic, .NET, ColdFusion technology, MicroFocus COBOL, Business Intelligence (BI), Crystal Report and REAL-e

TESTING METHODOLOGY: GAMP 5, Agile, RUP, Iterative and Waterfall

REGULATORY: FDA 12 CFR Part 11, EU Annex 11, GMP, GLP, GCP, GDP, GxP and CAPA

PROFESSIONAL EXPERIENCE:

Confidential, Houston, TX

Operations Manager

Responsibilities:

• Creating and maintaining client relationships, supplying bumper covers to collision specialists nationwide and insurance companies
• Managing the day to day operations and the company financials
• Marketing and creating brand awareness through the company website, social media and print
• Vendors Management
• Managing company personnel

Confidential, Somerset, NJ

Project Manager

Responsibilities:

• Quantifying, negotiating, architecting and finalizing the project artifacts and resource management (e.g. Communication Plan, RACI Matrix and Defect Management Plan)
• Identifying all the project activities to create and maintain the Project Plan
• Defining the project status data points and the other pertinent project meetings along with architecting their corresponding reporting presentation templates (e.g. Steering Committee Meetings and Project Weekly Status Meeting)
• Negotiating and finalizing all the Validation and Quality documents (e.g. Validation Plan, Quality Agreement, Vendor Audits and Protocols)
• Establishing and tracking the project budget
• Organizing and conducting the Project Kick Off meeting
• Facilitating the site level and cross-functional activities
• Vendor Management

Confidential, Somerset, NJ

Project Manager

Responsibilities:

• Working with the project sponsors, business and analysts to complete the project charter outlining scope, goals, success criteria, deliverables, roles and responsibilities, resources, budget, schedule and transition plan to Production Support
• Overseeing the successful implementation of the Global Serialization Solution throughout the manufacturing supply chain, from the line, to the NRM/repository, to the customer
• Client Management and ensuring product delivery
• Determining, tracking, analyzing and reporting the project milestones to the executives, project sponsors, steering committees, managers, stakeholders and customers
• Vendor Management of resources in the US, UK, Canada, Germany, France and Italy
• Resource Management of personnel in the UK, US and Germany
• Project Budget Management
• Engaging appropriate parties to create and manage project estimates
• Risk Management
• Ensuring compliance with Validation and Quality policies and procedures
• Ensuring Catalent’s customers are compliant to country specific serialization requirements
• Planning stage and technical discussions on migrating the Global Serialization Solution to Systech

Confidential, Parsippany, NJ

Project Manager | Program Validation Manager

Responsibilities:

• Successfully created, implemented, maintained and reported on a MS Project Plan of the Validation tasks and deliverables, which resulted in on time delivery and on budget
• Defined, implemented and maintained the RACI (Roles and Responsibilities) matrix for the project
• Developed MS PowerPoint Validation templates to deliver weekly progress reports on mitigation steps for any outstanding risks/issues for the PMO, validation, business and system integration meetings, the validation efforts and validation metrics.
• Reported to the project status and mitigation items to the PMO, stakeholders and the business
• Conducted Vendor Management between the line and the software implementation of the Track and Trace and ePedigree
• Successfully validated the implementation of a SAP Serialization System on time and on budget
• Coordinator to execute system integration Validation efforts along with the client, 3PL, CMO and manufacturing counterparts
• Conducted separate weekly Validation status meetings with QA-CSV and system integrator counterparts to review each member’s Validation progress and identify and mitigate any outstanding Validation issues/risks
• Liaison to the QA-CSV to ensure Validation compliance and negotiated Validation documents approvals
• Established and trained the four on-site and ten off-shore team members to complete Validation deliverables (i.e., IQ/OQ/PQ, URS and FRS)
• Ensured compliance with the client’s Validation procedures and protocols, served as Validation SME and created mitigation steps and resolved any validation risks/issues and reviewer of all Validation deliverables
• Created and completed the outstanding Validation documents (i.e., Validation Plan, Validation Summary, IQ/OQ/PQ Protocol/Summary) and negotiated final approval of all Validation documents with key stakeholders
• Functioned in the pharmaceutical regulated Validation space, GMP, GCP and GxP
• Identified, negotiated and quantified the Validation deliverables required for the SAP Serialization project using the GAMP 5 methodology

Confidential, Silicon Valley

Agile Tester

Responsibilities:

• Developed and implemented the Agile testing strategy that was utilized for all Sprints
• Created test cases for each story and executed test scripts during Cycle Testing, Acceptance Testing and Platform Testing
• Defined, planned and executed the testing tasks, schedule and resources for each Agile testing cycle
• Conducted daily and ad-hoc meetings with developers to discuss defects, new functionality, code delivery and code testability
• Created and reported testing status, metrics and mitigation strategies in the Daily Scrum meetings
• Contributed in Sprint Planning Meetings, Sprint Review meetings and Sprint Retrospective to provide testing perspective and input on improving each Agile testing cycle
• Utilized Rally to enter testing artifacts, generated testing status reports and testing metrics which were employed in the subsequent Sprint meetings

Confidential, Chicago, IL

Validation / Quality Assurance Lead

Responsibilities:

• Managed the execution of the System Integration Testing of ARISg 6.4.2 with a team of ten resources
• Created the entire suite of validation / test artifacts for System Integration Testing (i.e., MS Project Plan, Validation Plan, test scripts, traceability matrix)
• Oversaw the execution of Smoke Testing of the system new builds and the new development environments with a team of four resources
• Despite joining the project 3½ years after launch, authored and gathered approval of the Validation / Test Plan document for the entire AEGIS Upgrade 8.0.0 project using the GAMP 5 methodology which quantified and allowed the delivery of the Validation portion of the (Computer System Validation) engagement
• Consulted on the creation of the Validation Strategy
• Created the test cases for the validation efforts
• Conducted the review and final approval of the Validation documents
• Validation consultant on the testing efforts
• Functioned in the pharmaceutical regulated Validation space, GCP, GLP and GMP
• Utilized HP Quality Center 10 to record Validation protocol results and document Validation summaries

Confidential, Indianapolis, IN

QA Manager

Responsibilities:

• Authored the Test Strategy and the Test Plan utilizing the Iterative approach
• Created a QA department by establishing the QA standards utilizing best practices, procedures, the RACI (Roles and Responsibilities) matrix for the testing effort, testing protocol, testing scope, testing deadlines, testing infrastructure, and the testing automation suite utilizing an open source tool, WATIR
• Oversaw the testing phases, managed a team of eight testers and delivered testing on time and on budget
• Defined, created and maintained the testing artifacts and the testing deliverables
• Developed the testing reporting templates and communicated the testing metrics to management
• Defined, maintained and reported on all the testing activities which included defect management, test execution and test artifact generations
• Decreased testing iterations by 30% through vendor code stability, better requirements definition and standardizations
• Utilized Confidential Flex Builder and Oracle to implement an e-Commerce system

Confidential. Indianapolis, IN

Program QA Manager

Responsibilities:

• Oversaw and managed all the testing deliverables for the entire project and all testing phases which includes back end testing, system testing, integration testing, end to end testing, user acceptance testing and production verification
• Created and delivered the testing deliverables for each testing phase, which included the project plan, delivery dates, test plan/strategy, test cases/scripts, requirements/business scenario traceability, testing tools selection and test execution reporting using the Rational Unified Process (RUP) methodology
• Defined the reporting templates, maintained and communicated the program level testing activities which included defect management, test execution, test artifact generations and testing environment setup to the PMO
• Defined RACI (Roles and Responsibilities) matrix for the FEP testing effort
• Managed the 15 member FEP testing team and their testing efforts across the U.S.
• Coordinated with the Deloitte contingent for code delivery, testing and PMO objectives
• Executed and delivered all testing deliverables on time and on budget
• Utilized Rational to create and implement testing artifacts

Confidential, Indianapolis, IN

Engagement Manager

Responsibilities:

• Engagement Manager: Represented Confidential ’ interests with the client, interacted directly with the AIG managers on the project status and resolved any concerns, managed for all engagement level tasks, responsible for the engagement financials, created and executed the engagement processes to in corporate the ITIL methodology and contractual obligations and delivered the engagement on time and on budget
• Transition Manager: Architected and executed the Transition Plan for the engagement, Roles and Responsibilities and resource management; managed the Transition Phase of the engagement from AIA IT of ten team members to Confidential seven team members, identified and resolved gaps in the client’s processes, introduced streamline processes, and trained and mentored Confidential staff. Created and implemented the Incident Management and the Change Management procedures.
• Connectivity Manager: Defined, designed, configured and implemented the Connectivity Solution for (a) the connectivity between Confidential Bangalore facility and the AIG Wilmington facility, (b) configured and implemented the Confidential computing facility in Bangalore, by architecting the connectivity solution and leading a nine member team to gain client security access and configure the client’s network to allow a secure connection between the client in Wilmington and our Bangalore facility
• Consultant: Consulted on Confidential proposals to potential clients. Authored proposals and RFPs, documented the client’s current processes, conducted gap analysis, proposed Roles and Responsibilities and enhanced Confidential ’ processes including the ITIL framework and Incident Management/Change Management methodology.
• Engagement utilizing Java, Oracle, MicroFocus COBOL