Kristen Schmit
Independent Quality Systems and Clinical Compliance Consultant @Verdiva Bio
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WORK HISTORY
Independent Quality Systems and Clinical Compliance Consultant @Verdiva Bio
San Francisco, CA, US
Developed strategy for enterprise-wide, risk-based Quality Management System build (process, systems, and organizational design).• Established governance framework for computerized systems supporting Clinical, CMC, Regulatory, and Quality functions.• Implemented lifecycle risk management practices including validation planning, change control, and vendor qualification.• Provided QA oversight for clinical trial processes to ensure regulatory compliance and inspection readiness.• Supported qualification and validation of enterprise Records Management systems aligned with Part 11 and Annex 11 requirements.
EDUCATION
Plymouth State College
Psychology
SKILLS
ABOUT KRISTEN SCHMIT
Quality and Clinical professional. Traveling sailor, scuba diver, skier and motorcycle rider.
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