Kristen Schmit
Quality and Clinical professional. Traveling sailor, scuba diver, skier and motorcycle rider.
- Role
- Independent Quality Systems and Clinical Compliance Consultant at Verdiva Bio
- Location
- Cambridge, MA, US
- LinkedIn followers
- 500 followers
Experience
Independent Quality Systems and Clinical Compliance Consultant
Feb 2025 — Present · 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
1984 — 1988
Skills
- Pharmaceutical Industry
- Sop
- Fda
- Life Sciences
- Continuous Improvement
- Technology Transfer
- Pharmacovigilance
- Quality Control
- Gmp
- Cross-Functional Team Leadership
- 21 Cfr Part 11
- Medical Devices
- Capa
- Lims
- Clinical Development
- Quality System
- Ich-Gcp
- V&V
- Document Management
- Process Simulation
- Gcp
- Biopharmaceuticals
- Project Management
- Six Sigma
- Quality Auditing
- Software Documentation
- Edc
- Root Cause Analysis
- Ctms
- Glp
- Validation
- R&D
- Training
- Iso 13485
- U.s. Title 21 Cfr Part 11 Regulation
- CRO
- Biotechnology
- Regulatory Affairs
- Lifesciences
- Change Control
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