Teams at Kyverna Therapeutics

Lead strategy and execution of an in-house Trial Master File (TMF) function, transitioning from outsourced to internal operations. Ensure TMFs are inspection-ready across study lifecycle, manage Veeva Vault eTMF implementations and migrations, define governance and KPIs, partner cross-functionally, and support regulatory inspections and audits.

Lead QC oversight for clinical cell therapy manufacturing and external CMO labs. Own product specifications, stability programs, method validation/transfer, investigation of OOS/OOT events, COA generation, KPI monitoring, and risk-based quality management to support multi-phase clinical programs.

Lead and oversee CDMO execution for cell therapy clinical and commercial programs. Drive supplier performance, GMP compliance, audits, change control, investigations, and Person-in-Plant activities. Implement metrics, operational improvements, risk-based quality strategies, and supplier relationship management. Coordinate cross-functional stakeholders, support regulatory readiness, mentor team members, and support due diligence. Travel to manufacturing sites as needed (up to 25%).