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| | Click here or scroll down to respond to this candidateCandidate's Name , PMP, CISA, PSMEMAIL AVAILABLE PHONE NUMBER AVAILABLE LINKEDIN LINK AVAILABLEWheeling, WV Street Address
Expert Global Enterprise IT Project Manager & Federal IT Program DirectorVersatile, results-driven professional with 20+ years of comprehensive experience developing exceptional relationships with clients, peers, and senior leadership to deliver sustainable business solutions. I have proven problem-solving and analytical-thinking expertise, a fast-learning curve, and the ability to adapt to evolving industry trends. I am a dedicated professional with the drive and skill-set to excel in a fast-paced leadership role, enhancing the ability to capture and maintain customer satisfaction and project acceptance.CORE COMPETENCIESProgram / Project Mgmnt - MS Project, JIRAVendor / Account ManagementUser / Functional Requirements GatheringContracts Management / NegotiationsChange Management - ServiceNowTest Management HP ALM Quality CenterDocument Management Documentum, VeevaStakeholder CommunicationsRisk/Mitigation & Information Security Mgmnt.Data Migration / Conversion / CertificationFDA 21 CFR Part 11 Compliance - IQ, OQ, PQResource and Capacity Processing - WorkdayTECHNICAL SKILLS Microsoft Project Clarity PPM PMO SDLC Agile Scrum GMP CSV Lean Six Sigma MS Powerpoint OneNote Visio SaaS MS Sharepoint MS SQL SAP Oracle JIRAPROFESSIONAL EXPERIENCES AND ACHIEVEMENTS(TECHVIZE, LLC., Wheeling, WV) IT Advisory Services (Self-Employed) Jan. 2018 PresentSenior Contract Consultant providing experienced IT project/program management and analysis to Commercial and Federal clients in the WV, OH, PA and REMOTE regions.Completed a 6-month project (Aug. 2021 Jan. 2022) as the GXP Test Lead, through Aspirant in Pittsburgh, for Glaxo Smith Kline in the UK, on global replacement of their Clinical Trials Management System in Veeva Vault. I managed the validation team in India performing the testing processes and documentation. Project was completed on original schedule despite several set-backs during execution.Completed contract with Kevin Coyne Enterprises (Sept. 2019) performing network and password upgrades.Performed other short-term IT Management consulting(See Mylan Pharma Section below for more consulting details).MYLAN Pharmaceutical, Pittsburgh, PA (Contractor Oct. 2013 - Mar. 2016) (Employee Apr. 2016 Nov. 2017)Project Manager, Mylan Global Operations IT Scientific Affairs (Regulatory Affairs, R&D, Quality, Manufacturing)Managed Mylan must-have Global IT Operations projects involving highly regulated US and foreign health agencies. Led global cross-functional teams through research, define, design, build, test, implement, and manage project phases.Managed formal test / validation processes of FDA, DEA, and EMEA highly regulated GxP CSV environments.Prepared and presented PMO phase gate review sessions to upper management for Q&A and document approvals.Prepared and updated project budget estimates, project resources, scope, requirements, and detail project plans.Prepared and conducted kick-off, working group, workshops, and steering committee meetings and presentations.Analyzed and prepared project change requests for scope, budget, schedule, and risk mitigation revisions.Prepared and presented weekly and bi-monthly project status reports to stakeholders and upper management.Delivered fully tested and validated: FDA Generic Drug Application Publishing (Submission) replacement system, FDA Application Scheduling Workflow tracking system, FDA Comment Letter tracking and metrics reporting system.Developed business relationships within Mylan CIO, Legal, Contracts, Quality, Security, and Infrastructure to manage several priority projects inside and outside of Global Scientific Affairs.Managed and delivered: SAP R&D Instruments Preventative Maintenance system, FDA Non-Clinical mandatory SEND data collaborative review system, and UK office Lotus Notes email conversion to MS Outlook.Took over the R&D Controlled Substance Inventory tracking and DEA reporting system project to include re-negotiating with vendors and delivering final in-production system in under 12 months and within budget.Performed requirements gathering and vendor selection for replacement of Suspicious Order Monitoring system.Managed initial requirements and mock-up for phase one of Global Quality Product Metrics dashboard for Mylan CEO and Health Authority reporting system.KEYLOGIC SYSTEMS, INC., Morgantown, WV April 2012 May 2013 Program Manager, Federal Health IT ServicesDirected Health IT projects involving the Centers for Disease Control and the National Institute of Health (NIH). Led the analysis and bid/no-bid decisions for task order requests from Raytheon Corporation under a new subcontract at NIH.Developed corporate strategy and led proposal capture efforts, including negotiating teaming efforts with SRA International and Sevatec LLC for pursuing long-term Federal IT contracts.Supported KeyLogic recruiting efforts by conducting the final interviews for Health IT personnel.Supervised Federal proposal effort for major five year IT Support Services to Centers for Disease Control (CDC).TMC TECHNOLOGIES INC., Fairmont, WV Feb 2011 Mar 2012Vice President
Project Manager Federal ProgramsManaged IT projects that included: Proposal Development, Contract Negotiation, Staff Building, Security Requirements training, Execution Management (DoJ, CDC, NASA, U.S. Army). Oversaw all Accounting, HR, Contracts, and Finance operations.Marketed and negotiated Centers for Disease Control (CDC) infrastructure support sub-contract with Hewlett Packard.Led the process to obtain TMCs accounting system approval by the Defense Contract Audit Agency (DCAA) for cost-plus contract reporting and reimbursement on Federal contracts.HGO TECHNOLOGY, INC., Wheeling, WV Sep 2000 Jan 2011President and Chief Executive Officer, Program Director Federal Contracts DivisionInformation Technology consulting company developing software systems, performing systems analysis, and selling, configuring, installing, maintaining: HP Servers, MS Applications, Cisco appliances.Based on previous experience as a Corporate Controller with a 16-store retail company, I founded, led, and managed strategic direction of this information technology company serving federal and commercial customers nationwide.Started 4Rensix division providing computer forensics and security consulting to wide range of customers.Managed the startup and subsequent sale of an Internet Service Provider (ISP) division to a private phone company.Negotiated and managed the financing and construction of a new 5,600 square-feet corporate headquarters building.Led development of Web automobile buying site and a cabinet making production scheduling system.Managed major Federal IT Software Development and Infrastructure Support Contracts awarded to HGO Technology:CENTERS FOR DISEASE CONTROLoProgram Director, NIOSH Cincinnati, OH Information Systems Support ($15 million, 5 years, staff of 40)oProgram Director, NIOSH Morgantown, WV Information Sys. Support ($38 million, 10 years, staff of 35)NATIONAL AERONAUTICS AND SPACE ADMINISTRATION (NASA), Huntsville, ALoProject Manager, Space Station Freedom (Agency-wide Ada Software Usage and Performance Analysis)REICHART FURNITURE COMPANY, Wheeling, WV Sep 1995 Sep 2000Corporate Controller Financial, Accounting, IT ManagerWas responsible for all Accounting and Information Technology processes for this 16-store Retail Furniture Operation.Left the company to start an IT Consulting company, and was called back to supervise Reicharts system conversion and installation of a purchased turn-key retail furniture software application and computer system including accounting, warehouse inventory and appliance service center operations.Planned and supervised the successful move of the entire computer and accounting operations center move from Ohio to West Virginia in one weekend with no downtime for personnel.Managed all tax filings and financial reporting for the multiple corporation entity.EDUCATIONBS Accounting/Computer Science equivalent based on experience & West Liberty University, West Liberty, WVComputer Programming Certificate Electronic Computer Programming Institute, Pittsburgh, PAInformation Security Governance Strategy, Frameworks, Risks, Responsibilities (Michael Shannon)CERTIFICATIONSPMP (#1794979 Since 5/13/2010) - Project Management Professional, Project Management Institute(PMP certifies the extensive knowledge and experience of project management processes and standards)CISA (#0541547 Since 9/13/2005 ) - Certified Information Systems Auditor, Info Sys Audit and Control Assoc.(CISA certifies the extensive knowledge of Auditing, Assurance, and Security of Information Systems)PSM-1(Since 8/31/2018) Certified Professional Scrum Master, Scrum.Org by Ken Schwaber, co-creator of ScrumLean Six Sigma White Belt Certification, Breakthrough Performance Group, LLC |