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Senior Project Manager Resume

SUMMARY

  • An innovative technical and operational leader with over 15 years of experience working with Global Fortune 500 companies as well as smaller startup companies, including Pharmaceutical, Medical Device, Security Systems, Insurance, e - Commerce and Aerospace.
  • Recognized as an experienced and effective Software Program Manager and authority on Software and Systems Regulatory Compliance and lifecycle management from requirements definition through system integration and post-release change management and support.

PROFESSIONAL EXPERIENCE

Senior Project Manager

Confidential

Responsibilities:

  • Led Confidential team in performing quantitative analysis of problem and proposed solution evaluation
  • Developed Business Case for CFO funding approval
  • Functioned as the Agile Product Owner for both development and validation - conducted user acceptance survey Validation Element owner for Business Unit developed SW Tool and Process Validation Procedures.
  • Managed SAP validation and ongoing change management
  • Managed SW Tool Validation Remediation Program

Confidential

Senior Manager IT

Responsibilities:

  • Recruited to manage Sarbanes-Oxley compliance and manage yearly SOX Audits for IT Department
  • Appointed interim Director of IT and initiated implementation of ITIL processes and tools for SOX
  • Program managed remediation of JD Edwards SOD issues - team of outside consultants and business owners, reworked all financial business processes, and validated changes passing SOX audit
  • Recruited to program manage implementation of enterprise Confidential tool for eCTD management - managed team composed of external consultants and business owners from Regulatory, Manufacturing, Purchasing, and Confidential

Confidential

Senior Manager IT

Responsibilities:

  • Recruited to support remediation of FDA 483 findings - laboratory systems and process tools
  • Defined integrated computer systems, lab automation, and Laboratory Information Management Systems modules (LabView) to improve compliance.
  • Developed Electronic Laboratory Notebooks (proof of concept).
  • Developed TrackWise - Audit Module, Incidents & Laboratory Deviations, Corrective and Preventive Action (CAPA), MedWatch, Adverse Events.
  • Developed model to assess third party product suppliers qualifications for Business Development Team - significantly reduced risk in selecting acquisitions

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