Teams at Kyverna Therapeutics

Lead development and execution of a risk-based enterprise compliance program supporting commercialization readiness. Build governance, policies, monitoring, third-party diligence, training, reporting, and investigations. Serve as strategic partner to executive leadership, manage cross-functional initiatives and compliance team growth, and establish metrics to evaluate program effectiveness.

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.