SUMMARY Manager and Project Coordinator of Scientific Systems with over 25 years of experience in the Pharmaceutical and Scientific field. Well versed in FDA Regulations for scientific data collection validation. Proven ability to work in coordination with Clients and Project Teams to conform to FDA Regulations. Ability to meet deadlines, working independently or as a team member. Expertise includes: * Instem Centrus Suite (submit, submit Requester, SENDView (CVS) * CVS (Validations, Change Control, Periodic Review) * Provantis * Developing Global SOP's for Validation * GxP * Supporting Non-Clinical Safety GLP and non-GLP projects both Global and Local.

Highlights:

• Pathology
• Toxicology
• CVS
• Pre-clinical
• Validation
• GLP
• Legacy
• Project Leader