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