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J. Greene

James Greene

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Curriculum Vitea

Curriculum Vitea (0.4 MB)


  • B. Sci. Computer Science (California Lutheran University, 1987)

Professional Experience

  • 30 years professional work experience (USA / Germany / Switzerland)
  • Certified Project Manager - PMI PMP® (Project Management Professional, 2009-2018) and PRINCE2
  • Certified Representative for Computerised Systems Validation (CSV-Beauftragter / Concept Heidelberg)
  • Certified Auditor for Quality Management Systems (ISO 9001:2015) (QM-Auditor / TÜV Süd)
  • Leadership experience: Managing Director (AG/Corp., GmbH/Inc. and sole proprietorship), Department head and Team leader; up to 12 direct reports

Volunteer Experience

Areas of Expertise

  • Program and Project Management (PMBoK® Guide, PRINCE2)
  • Computerized Systems Validation (GAMP® 5)
  • Quality Management Systems (ISO 9001)
  • Service Management Processes (ITIL / ISO 20000)
  • Risk Management Systems
  • Technology Migrations
  • Software Development and Deployment
  • Web technologies

Industry Experience

  • Life Science Industries (Pharma, Med Tech, Suppliers)
  • High-Frequency Electrical Engineering
  • Chemical Industry
  • Educational Institutions
  • Non-profit Organisations

Technical Core Competencies

  • Information Technology Project and Program Management
  • Operational Change Management (SAP Solution Manager)
  • Information Security
  • Web Publishing and Programming

Language Skills

  • English (mother tongue)
  • German (B1 language certificate "sehr gut")

Major Projects

  • Validation Manager for operational Change Management (ChaRM) for an international pharmaceuticals company.
  • Validation Lead for a medical device manufacturer preparing for an FDA inspection
  • Audit support by the suppler assessment for a cloud-based pharmcovigilence system (Veterinary products)
  • Program management for a series of IT infrastructure carve-outs following 3 concurrent corporate divestitures. (Chemicals industry)
  • Program management for the IT infrastructure integration following a corporate merger. (Chemicals industry)
  • Validation Manager by the development of a cloud (PaaS)-based reporting system (Pharmaceuticals industry)
  • Program management of a global technology migration (IT Infrastructure, Chemicals industry).
  • Planning a global e-mail migration from Lotus Domino to MS Exchange for an international pharmaceuticals company.
  • Leading the development of financial forecasting tools for a clinical trial management system for a major pharmaceuticals company
  • Leading the migration (re-configuration) of hundreds of Windows®-based end-user workstations
  • Design the standard desktop configuration for a major pharmaceutical company
  • Document and publish the global client / server system standards for a major pharmaceuticals company
  • Manage the international roll-out of a client / server information system
  • Design and implement the Internet presence for a medical equipment manufacturer
  • Engineering and quality assurance of Entrust Public Key Infrastructure client tools

See Also ...

My LinkedIn Profile
My XING Profile
My Curriculum Vitae
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