Director, Project Integration and Quality Systems
Professional Experience
15+ years experience leading multi-functional project teams in all aspects of the FDA-regulated medical device product development cycle. Specific expertise in program management, in-vitro diagnostic assay design, product development, design control processes, quality systems, ISO/GMP environments, regulatory submission documentation (510K, PMA, CE Mark), and Phases 1-4 clinical drug trial management.
- Director, Operations, Innovenn
- Director, Operations, Improvita
- Corporate Portfolio Manager, Innovenn
- Project Manager, CPS, Covance
- Project Manager, Clinical Data Analysis & Reporting Organization, Covance
- Senior Manager, R&D, Hologic
Certifications
- Master’s Certificate Project Management
- Six Sigma Green Belt
Education
Bachelor of Science in Genetics from the University of Wisconsin – Madison
