Michael Schwartz
Head of Quality Assurance @Orna Therapeutics
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WORK HISTORY
Head of Quality Assurance @Orna Therapeutics
Watertown, MA, US
Spearheaded the Quality Assurance team for Phase I mRNA product pipeline for targeted oncology therapies · Implementing the GxP Quality Management System (Good Laboratory, Clinical, and Manufacturing Practices) · Customer Relationship Management/set up all Quality Agreements for CDMO oversight for Investigational Product · Developed comprehensive training programs for entire site preparing for GxP Inspection Readiness and Regulatory Compliance · Championed continuous process improvement initiatives, streamlining internal workflows and effective quality-related cycle times
SKILLS
ABOUT MICHAEL SCHWARTZ
Dynamic and results-driven Quality Compliance Executive with polyvalent Good…
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