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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