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Debra Bartel

Sr VP of Quality Assurance @ProPharma

Chicago, IL, US
EMAILS
[email protected]
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Jun 2021 — Present

Sr VP of Quality Assurance @ProPharma

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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

1994

University of Wisconsin

Master of Business Administration (M.B.A.)

1988

University of Wisconsin

BS, Management Information Systems

SKILLS

Project ManagementTraining Development and DeliveryCompliance with Regulations & Standards: Fda, Eudralex, Ich, GampChange ManagementSix SigmaQuality ControlFocus GroupsIT Governance Design and ImplementationQuality AssuranceU.s. Title 21 Cfr Part 11 RegulationProcess ImprovementAuditing and Audit PreprationPmpLeadership21 Cfr Part 11Personnel ManagementValidationCross-Functional Team LeadershipLifesciencesStrategyFinancial Analysis and ModelingProcess Design and Improvement - Cssgb CertifiedProject Management - Pmp CertifiedQuality SystemQuality Program DevelopmentIT System Design and DeploymentPharmaceutical IndustryBusiness Process ImprovementFdaU.s. Food and Drug Administration (Fda)

ABOUT DEBRA BARTEL

I have great enthusiasm for applying practical, effective approaches to meeting the…

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