PROGRAM MANAGER Resume Cambridge, Massachusetts - Hire IT People

EXPERIENCE SUMMARY:

Biopharma industry thought leadership and proven experience in the planning, deployment & adoption of global enterprise Quality and Regulatory Information Management systems
Empower IT to drive Regulatory & Quality business process improvements resulting in quantifiable Safety, Time to Patient & Compliance improvements
Quality Management System
Quality Process Management - Change Control, Deviations & CAPAs, Effectiveness Checks
Regulatory Information Management (RIM)
Submissions Planning & Management, Registrations
Clinical - eTMF Trial Management
Leverage real world current Biopharma Iterative / agile SDLC implementation methodology to drive go-live & adoption
Financial & Portfolio Management, Leadership reporting
Building, maintaining and driving Executive sponsorship & alignment on IT value added services
Develop / revise and adopt a M&A “playbook” on the consolidation of acquired RIM, Confidential and other business critical gXp platforms
Commitment to core values including Patient Safety, Integrity, Teamwork & Perseverance

PROFESSIONAL EXPERIENCE:

PROGRAM MANAGER

Confidential, Cambridge, Massachusetts

Responsibilities:

Comprehensive IT & Business Program & Project Management capabilities for any Confidential or Confidential project
Veeva, TrackWise, Clarity, HPALM, Document OpenText, MasterControl, PAREXEL Insight Publisher, SAP
Iterative “agile” SDLC Validation & risk-based Testing methodology
Commercial Manufacturing Readiness (CMR)
Governance, Stakeholder Engagement & Communications
Business Analysis
Vendor & Portfolio Management
Testing, Training & Adoption
IT Roadmaps & Financial Planning

DIRECTOR, QUALITY SYSTEMS IT BUSINESS PARTNER

Confidential, Foster City, California

Responsibilities:

Confidential IT Business Partner responsible for global ECM capabilities including Quality Docs, CAPAs, Deviations and Electronic Trial Master File (eTMF)
Portfolio & Program Management, Quality Management Systems
Information Technology Advisory Council (ITAC), ECM Steering Committee and IT leadership teams
ECM lifecycle portfolio - responsible for the identification, prioritization, budgeting, and planning
Managed IT budgets more than $10M and global matrixed teams in the US, UK & India
Established and managed an ECM global center of excellence (COE) in Hyderabad
Management of Level 3 support for 8,000 data consumers and constituents
Solutions include Clarity, Documentum, FirstDoc, Generis Cara, Master Control, OpenText, SharePoint, & Veeva eTMF and Quality Docs

ASSOCIATE DIRECTOR, IT BUSINESS PARTNER - QUALITY SYSTEMS

Confidential, Cambridge, Massachusetts

Responsibilities:

IT Business Partner responsible for global ECM capabilities including Quality Docs, CAPAs, Deviations and Electronic Trial Master File (eTMF)
Portfolio & Program Management, Quality Management Systems
Managed global matrixed teams in the US, Italy & India
Enterprise systems consolidation & optimization (Including 12K OpenText Confidential upgrade)
Clarity, HP Quality Center, OpenText Content Server, Paraexel Insight Publisher, SharePoint & Veeva

PROJECT MANAGEMENT, PMO

Confidential, Boston, Massachusetts

Responsibilities:

ECM Project Management, PMO & Business Analysis
Apply 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.
Platforms included Clearwell, Documentum, HP Autonomy, OpenText, Qumas & SharePoint

SR. MANAGER, ECM RIGHTSHORE CENTER OF EXCELLENCE (COE)

Confidential, Fort Worth, Texas

Responsibilities:

Global Document Management outsourced services for Aviation & Pharma
Managed a global matrixed team comprised of business analysts, program managers, architects, developers and subject matter experts
Established / enhanced strategic global partnerships with Dell, EMC Documentum, HP, Microsoft, OpenText, PTC, SDL & UGS Siemens

MANAGING DIRECTOR

Confidential, Burlington, Massachusetts

Responsibilities:

Document and Cased Based Reasoning (CBR) knowledge management software solutions. Global implementations included the US Department of Defense (USMC JCALS next generation) and Lifesciences Medical Equipment web content publishing.

REGIONAL MANAGER

Confidential, Wakefield, Massachusetts

Responsibilities:

SGML Publishing & Content Management software solutions. Global implementations including Lifesciences Structured Product Labeling Space Command and Boeing.