Bruce Griffin

Principal Compliance Manager @TetraScience

Sunnyvale, CA, US
EMAILS
b•••••••@tetrascience.com
MOBILE NUMBERS
+14•••••••24

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WORK HISTORY

May 2022 — Present

Principal Compliance Manager @TetraScience

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The Tetra Scientific Data & AI Cloud™ is the only open, cloud-native platform purpose-built for science and providing life sciences companies with the flexibility, scalability, and data-centric capabilities to enable easy access to centralized, harmonized, and actionable scientific data. I\'m delighted to be using my decades of scientific and regulatory experience to build a best-in-class GxP offering that takes advantage of the FDA\'s CSA approach, which I\'ve been advocating for over a decade. My team and I have built an ISO 9001-compliant Quality System from the ground up, We achieved ISO 9001 and ISO 27001 certifications as well as a SOC 2 Type II attestation. One of the main blockers to successful application of AI to pharmaceutical research, development, and manufacturing is data silos and proprietary formats. We\'re here to solve that problem.

EDUCATION

1986 — 1990

Santa Clara University

Bachelor of Science

SKILLS

AnalysisTechnical TrainingChange ManagementTechnical Documentation21 Cfr Part 11GxpSoftware DocumentationSdlcLifesciencesQuality AssuranceValidationHplcComputer System ValidationAnnex 11CgmpGampBiotechnologyBusiness AnalysisComplianceMedical DevicesProcess ImprovementQuality SystemTestingPharmaceutical IndustrySopFdaTechnical WritingDocumentationGmpGlpRisk ManagementLims

ABOUT BRUCE GRIFFIN

Experienced IT Compliance and Computer System Validation (CSV) and Computer Software…

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