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Managing Consultant Resume

SUMMARY

  • Design, fielding, operational management, and sustainment, of global GxP Quality Management Systems (QMS) including SOPs, eTMF, CRO, CMO and submission publishing. Biotech & Pharmaceutical industry compliance & business processes.
  • Enterprise Content Management (ECM), Document Management Thought Leader with more than 20 years’ experience in successfully guiding operational, compliance, strategic, budgetary, and financial aspects of GxP & non - GxP cost centers up to $20M and 300+ global matrixed resources.
  • Design, implementation, acceptance, and governance of more than 60 on premise and cloud-based enterprise GxP / non-GxP ECM & e-Discovery solutions to clients around the world in the Aviation, Banking, Biotech, Government, Insurance, Legal, Life Sciences and Manufacturing industries.

TECHNICAL SKILLS

  • Global Cloud based SharePoint Office 365 implementation supporting 12,000+ users - Biotech
  • Enterprise SharePoint intranet, collaboration - Biotech
  • SharePoint Document Management System (DMS) - State Government
  • GxP OpenText / Documentum upgrades - Biotech
  • Electronic Trial Master File (eTMF) upgrade - Biotech
  • Veeva Vault Commercial, Contract Manufacturing Organization (CMO) & Contract Research Organization (CRO) collaboration portal – Biotech (multiple clients)
  • OpenText Documentum SOPs based on DIA and other Metadata standards – Biotech (multiple clients)
  • Paraexel e-Submissions solution - Biotech (multiple clients)
  • 80+ Commercial Sitecore Web Content Management (WCS) Global Internet Sites – Biotech
  • SharePoint & Autonomy e-Discovery collaboration portal – Legal, Media & Entertainment
  • Document Management Managed Services (DMMS) Centers of Excellence (COE) in Bangalore, Mumbai & Hyderabad – Life Sciences and Aviation
  • OpenText & QMS eTMF – Biotech
  • Qumas QMS and Electronic Lab Notebook (ELN) Standard Operating Procedure (SOP) – Biotech
  • HP Quality Center upgrade – Biotech
  • MacAfee anti-virus software – Biotech
  • Enterprise Windows 10 upgrade - Biotech
  • GxP Validated Systems
  • Content, taxonomy, and classification schemes based on industry standards including DIA Reference Model
  • Daily, Weekly & Monthly Stakeholder Updates and Executive Leadership Presentations
  • Monthly and annual budgets, reports
  • Project and financial plans, team management, value creation
  • ITIL based IT roadmaps
  • Project charter and Responsible, Accountable, Consulted and Informed (RACI)
  • User, business, and functional requirements
  • System and design specifications
  • Quality / audit documentation, traceably matrix, user and acceptance testing
  • COTS vendor evaluation including Alfresco, IBM FileNet, Generis CARA, Kofax, Microsoft SharePoint, OpenText Documentum, Sitecore, Veeva Vault & other 3rd party alternatives

PROFESSIONAL EXPERIENCE

MANAGING CONSULTANT

Confidential

Responsibilities:

  • Key member of the Information Technology Advisory Council (ITAC) extended ECM global steering committee
  • Directed global matrix staff at multiple layers
  • Recommended & directed selection & implementation of GxP & non-GxP ECM technologies & IT projects which support business & functional objectives
  • Ensured compliance of ECM managed GxP systems, with processes enabling compliance & resources trained & focused on ensuring compliance. Develops & enforces necessary policies & procedures which facilitate compliance & organizational objectives. Ensured the continuous improvement, rationalization & management of existing GxP systems & operations.
  • Oversaw projects & ensures their delivery in accordance with project goals, time scales & costs

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