Senior Manager, Quality Management System (QMS)

About the role

Kyverna Therapeutics is seeking a Senior Manager to lead its Quality Management System (QMS) across product development and commercialization. The role partners with Technical Operations, Clinical, Regulatory Affairs and other functions to ensure compliance with US, EU and ICH regulations while scaling the system as the company grows.

Key responsibilities

• Manage and maintain SOPs, workflows, and processes for Deviations, Investigations, CAPA, Change Control, and Quality Metrics.
• Provide QA oversight of IT systems that support GxP processes.
• Lead implementation, configuration, validation and optimization of the electronic QMS (eQMS).
• Define data governance, system configuration, user roles and reporting requirements.
• Monitor QMS effectiveness, identify gaps, and drive continuous‑improvement initiatives.
• Develop, analyze and present quality metrics and KPIs for regular review.
• Create and deliver training on QMS processes, data integrity and eQMS functionality.
• Support inspection readiness and ensure adherence to cGMP, regulatory mandates and internal standards.

Required profile

• Senior‑level experience in quality systems within a biopharmaceutical or cell‑therapy environment.
• Strong knowledge of US, EU and ICH regulatory requirements.
• Proven ability to work cross‑functionally and influence stakeholders.
• Excellent analytical, problem‑solving and communication skills.

Required skills

• Electronic Quality Management System (eQMS) implementation and validation.
• GxP process oversight.
• cGMP compliance.
• ALCOA+ data integrity principles.
• Quality metrics analysis and KPI reporting.