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