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Owner Resume

SUMMARY

  • Quick learner, pragmatic leader and team player with very successful history of partnering with functional teams and delivering solutions that meet or surpass expectations while maintaining the right mix of technology and business process innovation
  • Highly experienced in supporting Regulatory, Quality, R&D, Clinical, manufacturing and supply chain processes in FDA regulated environment. Experience selecting, designing, developing, validating, deploying and supporting ERP, PLM (Windchill), QMS (Trackwise), finished goods labeling (PrisymID - Medica Web), MES (CAMSTAR) and other off the shelf and home grown GxP software solutions.
  • Led teams in the design, development, deployment and support of new global solution for product labeling at manufacturing and distribution sites as well as at contract manufacturer sites. (PrisymID-Medica Web)
  • Led teams in the design, development, implementation and support of new global solution for complaint handling, CAPA and NC, UDI submissions (GUDID)- (Trackwise).
  • Leadership role in program/projects involving migration from HIBC to GS1 barcode as part of UDI initiative. IT lead on team that set standards around the use of GS1, data definitions and implementation strategy to ensure compliance with standard and UDI.
  • Strong understanding of R&D/new product introduction, document management and change control processes and how these processes relate to downstream systems and processes. Experience supporting R&D, RA/QA, Document management teams in defining and implementing strategies and solutions for generating and managing design history files, device master records and device history records.
  • Experience designing and developing eDHR solutions and local solutions for quality data collection to support acceptance activities -incoming and in process-.
  • Proven track record with process standardization and application rationalization as a means to achieve economies of scale, cost reductions and simplification of the overall enterprise architecture.
  • Delivered multiple solutions of global scope supporting the globalization and standardization of various business processes.
  • Highly experienced in working with multicultural and virtual teams around the world, building strong and everlasting professional relationships in the process
  • One of select group of 6 IT leaders chosen to perform scoping, planning and subsequent implementation for the company’s largest project involving divestiture and integration efforts lasting two years

TECHNICAL SKILLS

  • ERP, PLM, MES, QMS, Product Labeling, PRMS, Windchill, Trackwise, CAMSTAR, Medica Web (PrisymID), LabelView, CTMS, Argus Safety
  • RFID, Java, J2EE, EJB, Swing, Hibernate, JBoss/Wildfly, JDBC, JMX, SOAP and REST Web Services (XML, JSON), AngularJS, XSL, AS400/iSeries, OS400, DB2400, Service Programs, Subfiles, Amazon AWS and SQS
  • Java, J2EE, JBoss/Wildfly, JMS, Web Services (SOAP,REST -XML, JSON-), Drools, OS400 API’s, RPGLE, Service Programs, Data Queues
  • Linux, Samba,Apache, MySQL, Spring, Struts

PROFESSIONAL EXPERIENCE

Owner

Confidential

Responsibilities:

  • IT consulting services and software products

Senior IT Manager

Confidential

Responsibilities:

  • Member of the IT leadership team supporting Global Quality and Operations. Responsible for budgeting, roadmaps.
  • Responsible for design, development, validation, deployment and support for global labeling solution.
  • Successfully deployed solution to 7 divisions, over 30 manufacturing sites, distribution centers and contract manufacturers
  • Responsible for support of MES and asset management solutions
  • Responsible for keeping validated GxP systems in state of control after initial validation and deployment and responsible for providing support during FDA, internal and notified body audits.

Associate IT Director

Confidential

Responsibilities:

  • Member of IT global solutions team
  • Responsible for making Make vs Buy decisions, budgeting, roadmaps.
  • Worked very closely with business leaders in analyzing business needs, recommending solutions and putting together business cases for the implementation of global solutions.
  • Selected and implemented multiple solutions to address business needs in Quality, Regulatory, Asset Management, Calibration, Product Labeling
  • Managed three teams responsible for design, development, validation and deployment of global NC, CAPA solution, Complaint Handling, quality data collection, calibration. asset management and clinical systems.
  • Team was comprised of 12 FTE’s and 8 contractors.
  • Responsible for full validation of all systems and ensuring systems were kept in state of control.
  • Provided evidence of validation, state of control during FDA and notified body audits.

Programmer, Technical Manager, Manager, Senior Manager

Confidential

Responsibilities:

  • Held multiple roles of increasing responsibility from individual contributor (Programmer) to Senior Manager
  • Designed, developed, validated and deployed solutions using ERP, PLM, web applications, etc. supporting manufacturing, quality, logistics, R&D processes.
  • Partnered with business leaders to analyze the need to standardize certain key processes prior to implementing automated solution.
  • Designed, developed and successfully implemented automated solutions for lot and serial numbering processes across multiple manufacturing sites.
  • Worked on multiple projects developing integration and data collection solutions with shop floor support systems such as laser markers, SPC (InfinityQS) and others
  • Managed small and medium size teams of full time employees and interns
  • Provided support and traveled to multiple company sites outside of the United States
  • Managed separate team responsible for service and support.
  • Completed initiatives leading to increased customer satisfaction.

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