Debra Bartel
VP of Quality Assurance
- Role
- Sr VP of Quality Assurance at ProPharma
- Location
- Chicago, IL, US
- LinkedIn followers
- 500 followers
About Debra Bartel
I have great enthusiasm for applying practical, effective approaches to meeting the…
Experience
Sr VP of Quality Assurance
Jun 2021 — Present · Chicago, IL, US
Leads US and international service delivery teams for GxP Quality Assurance services, including IT QMS development, Computer System Validation / Computer Software Assurance, Data Integrity, and IT GxP Compliance (e.g, Part 11, Annex 11).Provides IT GxP compliance consulting for pharmaceutical, biotech, and medical device companies, CROs, and IT services providers, including IaaS, PaaS, and SaaS.
Education
University of Wisconsin
Master of Business Administration (M.B.A.)
1994
University of Wisconsin
BS, Management Information Systems
1988
Skills
- Project Management
- Training Development and Delivery
- Compliance with Regulations & Standards: Fda, Eudralex, Ich, Gamp
- Change Management
- Six Sigma
- Quality Control
- Focus Groups
- IT Governance Design and Implementation
- Quality Assurance
- U.s. Title 21 Cfr Part 11 Regulation
- Process Improvement
- Auditing and Audit Prepration
- Pmp
- Leadership
- 21 Cfr Part 11
- Personnel Management
- Validation
- Cross-Functional Team Leadership
- Lifesciences
- Strategy
- Financial Analysis and Modeling
- Process Design and Improvement - Cssgb Certified
- Project Management - Pmp Certified
- Quality System
- Quality Program Development
- IT System Design and Deployment
- Pharmaceutical Industry
- Business Process Improvement
- Fda
- U.s. Food and Drug Administration (Fda)
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