Teams at Editas Medicine

Manage and improve phase-appropriate quality systems and vendor management to advance EDIT-401 into clinic. Administer Veeva document/QMS and ComplianceWire LMS, author and approve GMP documentation, oversee supplier qualification and audits, monitor quality/compliance metrics, and support QA operations including record reviews and dispositions.

Senior QA Specialist provides GMP quality oversight for EDIT-401 clinical candidate: batch record review, lot disposition, QA review of assay validation and test methods, CDMO oversight, authoring and approving GMP documentation, maintaining quality systems, vendor management, and supporting quality event management to ensure regulatory compliance for clinical manufacturing.

Lead QC analytical strategy for in vivo gene medicines (gRNA, mRNA, LNP): oversee method development/validation/transfer, GMP testing, specifications, stability programs, regulatory documentation, cross-functional teams, and external CDMO/CMO oversight to support IND/CTA and clinical manufacturing.