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
