Kyle Stoddard
Associate Director, Qa for Qc Compliance and Investigations Team @Genetix Biotherapeutics
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WORK HISTORY
Associate Director, Qa for Qc Compliance and Investigations Team @Genetix Biotherapeutics
Somerville, MA, US
Manage and Lead QC Compliance (QA for QC) Team responsible for QA Oversight and Support of Genetix/bluebird bio QC Testing supporting all clinical and commercial cell banks, plasmid, LVV, and Drug Products. QA Support of Method Lifecycle Management. Coordinate and Drive Quality Oversight Plan (QOP) for CTO and Draft and Revise bluebird bio/Genetix CTO quality agreements. QA Support of all QC owned QMS. Drive improvements to Lab Investigation (OOS, OOT, QC Trends, etc) process, procedure, communication and management. Routinely present metrics to QLT. Support DP Manufacturing Capacity Increase to exceed Genetix patient delivery goals for 2025.
EDUCATION
Bridgewater State College
Bachelor of Science - BS, Chemistry and Biology
SKILLS
ABOUT KYLE STODDARD
Associate Director, Quality Assurance
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