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Pmo; Udi And Serialization Subject Matter Expert Resume

Loveland, CO

SUMMARY:

  • Have got 20+ yrs. of Oracle ERP, warehouse management and manufacturing technology, implementation and transformation expert as well as experienced program and project manager.
  • Have provided highly valued, integrity driven subject matter expertise and program leadership to various organizations in both regulated and non - regulated industries.
  • Certified PMI Project Manager with deep expertise in ERP, MES, and PLM Implementation Methodologies including SAP ASAP, SAP Activate, Oracle UOM, and Microsoft Dynamics Sure Step. Well versed in project management methodologies including PMI PMBOK, Waterfall, Agile Scrum, Structured Agile and the ability to adapt or apply the right method to a specific project all while using prominent tools including Microsoft Project, Sharepoint, OmniFocus, Oracle, Primavera, HP PPM, Zoho Projects, Zoho Sprints, Asana, Clarify, Slack and others.
  • Extensive PMO and Project Management experience for large scale business and technology transformations initiatives on the behalf of customers managing small and large implementation partners and managed services providers including PWC, Confidential, SAP, IBM, DAZ, WIPRO, Hitachi, Inspirage, Cognizant, Oracle Consulting, Anderson Consulting, Atos and others.
  • Recognized as a deep and innovative Organization Change Management expert. Selected and re-elected four times as the Chairperson of the Technology Adoption Oracle OAUG User Group for 12 years. Focused on Organization Change Management of Oracle Technology Transformations.
  • Six Sigma Green Belt
  • Deep and recognized expert in the systems, applications, tools and processes that enable improvements in domestic and global Supply Chains including Discrete & Process Manufacturing, Shop Floor execution, Global Procurement and Supply Planning; Global Export and Trade Compliance; Shipping & Logistics; Warehouse & Inventory Management, Serial Tracking and Secure Supply Chain using the latest technologies.
  • A deep and recognized Oracle EBS Functional expert with experience implementing Oracle Financials, Procure to Pay, Quote to Cash, Order Management and Distribution, Product Configurator, CRM Service Contracts and Operations, Discrete Manufacturing, Process Manufacturing, Advanced Supply Chain Planning and Warehouse Management (WMS).
  • Led or participated in execution of several successful Enterprise Resource Planning (ERP), Warehouse Management System (WMS), Manufacturing Execution System (MES), Product Lifecycle Management (PLM) and Laboratory Information Management (LIMS) system implementations including Oracle EBS, Oracle ASCP, SAP ECC, JDEdwards E1, Oracle Agile PLM, Microsoft Dynamics AX, AX for Pharma, Camstar MES, Honeywell MES, Oracle MES, SAP ME, High Jump WMS, Oracle WMS, Tradesphere, TrackWise, LabWare, Core LiMS, Siemens TeamCenter, Kaplan Eduneering, EtQ, Master Control, Documentum, TraceLink, Antares as well as other leading consumer packaging and shop floor applications in locations all over the world.
  • Deep Life Sciences subject matter expertise on timely and relevant industry areas including: Mixed Mode Manufacturing Execution Systems, ISA 95/88 standards, Quality Management System development and improvement, cGMP compliance, Data Governance, Serialization, Unique Device Identification (UDI), Drug Supply Chain Security Act (DSCSA), Track & Trace, GS1, document management systems, facility and equipment validation, GAMP & Risk Based Approach to Computer Systems Validation especially for large enterprise systems.

PROFESSIONAL EXPERIENCE:

PMO; UDI and Serialization Subject Matter Expert

Confidential, Loveland, CO

  • Lead Integration with Oracle ERP
  • A global manufacturer and distributer of analytical instruments and reagents used to test the quality of water and other liquid solutions regulated by the US FDA.
  • Provided regulatory guidance regarding UDI and serialization requirements
  • Planning activities of implementation of a compliant serialization and labeling solution including 2D barcode verification system
  • Collaboration with customers, suppliers, contract manufacturers

Serialization Implementation Program and Project Manager

Confidential, Philadelphia, PA

  • installation and validation of serialization equipment from Antares and Marchesini across over twenty packaging suites and lines
  • Program and Project Manager responsible for leading the implementation for all serialization related tasks associated with the DSCSA compliance requirements for 2017 at the PCI packaging facility in Philadelphia. Leading this serialization initiative involves working with and gaining alignment across packaging operations, engineering, facilities, quality assurance, customer service, sales and IT departments as well as alignment with corporate management and other PCI locations to ensure consistent delivery to PCI’s customers label design and implementation changes for product bottle, carton labels as well as shipper and pallet labels across thousands of SKUs and customers
  • Integration and master data changes in JD Edwards
  • Integration with Tracelink as well as other specific customer ERP systems such as SAP, Oracle EBS, JD Edwards
  • Alignment of implementation strategies with all of PCI Philadelphia major customers and the PCI customer account teams. Lead all customer calls and status meetings with PCI’s major customers.

PMO and UDI Subject Matter Expert Consultant

Confidential, Newark, DE

  • The overall Program Lead for the Siemens Global UDI initiative which includes all products manufactured across 8 plants worldwide as well as OEMs. Solution included integration with SAP as well as integration with MicroScan LVS for barcode label generation and verification. Responsible for the progress of all day to day activities of all work streams and to ensure on time and on budget delivery.

MES Assessment, Program Leader

Confidential

  • Led a detailed operational and financial feasibility study to evaluate the implementation of a potential multi-site manufacturing execution system. Included assessment of capability and multi-site analysis of operations, processes, equipment, infrastructure, cost benefit analysis of Camstar vs SAP ME.
  • PMO and Change Management, Testing and Compliance Lead
  • Oracle EBS R12 Upgrade and Computer Systems Validation
  • Financials, Order to Cash, Procure to Pay, Warehouse Management, Discrete Manufacturing suite
  • PMO and Implementation Change Management, Testing and Compliance Team Lead
  • Multi-Site implementation and Computer Systems Validation of Oracle EBS R11i
  • Financials, Order to Cash, Procure to Pay, Process Manufacturing suite
  • Manhattan WMS
  • Quality Management System review and development
  • SAP Business One implementation and Computer Systems Validation
  • FICO, MM
  • Oracle EBS implementation, Upgrade and Computer Systems Validation
  • Financials, Order Management, Procure to Pay, Learning Management, Tutor implementation
  • Oracle EBS implementation Lead
  • Financials, Order to Cash, Procure to Pay
  • Oracle EBS implementation, Upgrade and Support
  • Financials, Order to Cash, Procure to Pay, Configurator
  • Oracle EBS implementation
  • Financials, Order to Cash, Procure to Pay
  • Financials, Order to Cash, Procure to Pay

Confidential, Newark, DE

Core Team Lead, Design to Cost Project

Lead the product engineering function to improve design of Siemens upcoming release of a new integrated solution of diagnostics analyzers with objectives of realizing a 30% reduction in cost savings resulting from improvements in material sourcing, product design and manufacturing processes as well as benchmarking competitor offerings.

Oracle Warehouse Management Implementation Program Lead

Confidential, Los Angeles, CA

Successfully led the implementation of Oracle Warehouse Management R12.2.4 process and system transformation at one of the leading vitamin manufacturers and packagers in the world. Completed all sprints of three implementations of Oracle WMS at different multi-site campuses in California and South Carolina in just seven months. Tasks included Program Management, best practice process re-engineering, configuration the broader solution including Oracle ASCP, MRP, Order Management, Financials and Process Manufacturing.

Sr. Supply Chain Consultant and Risk Supplier PMO Lead

Confidential, Flanders, NJ

Responsible for forming and leading a strategic cross functional task force to ensure key risk suppliers performed and delivered for a key multi-billion-dollar global product launch. Responsible for developing and leading all aspects of the Supplier Performance program including identification of the problem suppliers; developing measurement metrics, data collection in SAP ECC, leading meetings with key suppliers, training new supplier relationship managers and buyers and ongoing supplier quality, cost and delivery performance metrics.

PMO and Project Manager

Confidential, Norwich, CT

  • Global Manufacturing AX for Pharma temporary Project Leader for implementation of Microsoft Dynamics and AX for Pharma ERP solution.

Oracle Supply Chain Technology Subject Matter Expert Consultant

Confidential, Wayne, PA

  • Led the serialization and warehouse management integration track of newly combined companies to a single Oracle ERP warehouse management solution used across seventeen manufacturing, warehouse distribution and service centers all over the world. Transition included moving to full serial tracking through the entire supply chain including all contract manufacturers, all internal and third party logistics providers as well as deliveries to customers. Transition included leading the design, development, testing, implementation, training and support for all facilities all over the world. Modules included AR, Order Management, Procurement, Warehouse Management. Part of a core leadership group that helped grow an ERP implementation consultancy from startup to acquisition.
  • Financials, Order to Cash, Procure to Pay
  • Financials, Order to Cash, Procure to Pay
  • Oracle EBS implementation
  • Oracle EBS Upgrade
  • Financials, Order Management, Tutor
  • Oracle EBS implementation, Upgrade & Support
  • Financials, Order to Cash, Procure to Pay, Discrete Manufacturing
  • Order to Cash, Advanced Pricing
  • Oracle EBS implementation Lead
  • Financials, Order to Cash, Discrete Manufacturing, Shipping Execution
  • Oracle EBS implementation
  • PMO and Change Management, Testing and Compliance Lead
  • Financials, Order to Cash, Procure to Pay, Discrete Manufacturing, Warehouse Management, Installed Base
  • Microsoft Dynamics NAV support and Computer Systems Validation
  • Oracle EBS implementation; Financials, Order to Cash, Procure to Pay, Discrete Manufacturing suite, CRM
  • PMO and Change Management, Testing and Compliance Lead
  • SAP ME 6.1 implementation and Computer Systems Validation
  • Manufacturing Execution, MI
  • JD Edwards Enterprise One implementation and Computer Systems Validation
  • SAP ECC 6.0 implementation and Computer Systems Validation; FICO, MM, PP, CRM

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