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 wif 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 teh world in teh Aviation, Banking, Biotech, Government, Insurance, Legal, Life Sciences and Manufacturing industries.
• 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

TECHNICAL SKILLS

• 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 - Cambridge, Massachusetts

Responsibilities:

• Business Analysis, Solutions Architecture, Program and Project Management of ECM on premise, cloud and factory-based solutions. Specific areas include industry expert evaluation of next generation Life Sciences tool sets including Alfresco, Generis CARA, OpenText Documentum and Veeva Vault.

ENTERPRISE CONTENT MANAGEMENT

Confidential - Foster City, California

Responsibilities:

• Key member of teh 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, wif processes enabling compliance & resources trained & focused on ensuring compliance. Develops & enforces necessary policies & procedures which facilitate compliance & organizational objectives. Ensured teh continuous improvement, rationalization & management of existing GxP systems & operations.
• Oversaw projects & ensures their delivery in accordance wif project goals, time scales & costs

ENTERPRISE CONTENT MANAGEMENT

Confidential - Cambridge, Massachusetts

Responsibilities:

• Responsible for global ECM & EGA capabilities in Confidential including OpenText Content Server 10, SharePoint, Intranet Portals, Paraexel Insight Publisher & other GxP applications.

ECM & Confidential CONSULTING SERVICES

Confidential - Boston, Massachusetts

Responsibilities:

• ECM Project Management / Confidential & Business Analysis. C
• unsel wif business and IT as a trusted partner while applying quality standards to all SDLC work products including IT roadmaps, user, business and functional requirements, system and design specifications, quality / audit documentation, traceably matrix, RACI, user, and acceptance testing development.
• Experience wif SharePoint 2010, Qumas, Documentum, HP Autonomy, Clearwell & OpenText. Clients included Biogen, Madison Square Garden, Shire HGT, State of Massachusetts and teh RiverStone Group.

ENTERPRISE DOCUMENT MANAGEMENT

Confidential – Cambridge, Massachusetts

Responsibilities:

• Document management & e-Discovery global managed services for teh Aviation, Biotech, and sectors.
• Managed a team of 300 offshore & onshore technical resources.
• Established / enhanced strategic global partnerships wif Dell, EMC Documentum, HP, Microsoft, OpenText, PTC, SDL & UGS Siemens.

MANAGING DIRECTOR

Confidential – Burlington, Massachusetts

Responsibilities:

• Knowledge and document management software solutions. Responsibilities for $10M NA business included business development, operational and sustainment operations management, and customer satisfaction.
• Enterprise implementations included Bankers Systems, EDS, GE Energy, GE Medical Systems, Invensys, Rockwell Collins, Schlumberger, Up-to-date & teh USMC.