Provide quality expertise supporting the development and commercialization of Kyverna’s products in compliance with relevant US, EU, and ICH requirements.
Actively manage, develop, implement, and report on Quality Systems, including Deviations, Investigations, CAPAs, Change Controls, Quality Metrics, and electronic Quality Management Systems (eQMS).
Serve as a subject matter expert and strategic partner across Technical Operations, Clinical, Regulatory Affairs, and other cross-functional teams.
Ensure execution, scalability, and continuous improvement of Kyverna’s Quality Management System as the organization grows and matures.

Bachelor’s degree in Computer Science, Life Sciences, or a related field, or equivalent relevant experience.
Demonstrated experience implementing, administering, and improving an eQMS, including system configuration, validation support, and lifecycle management.
Minimum of 8 years of experience in the pharmaceutical or biotechnology industry, including 6+ years in Quality Systems / Quality Assurance.
Strong working knowledge of quality system data management, reporting, and data integrity principles.
First-hand experience managing and overseeing deviations, investigations, CAPAs, and change controls in a regulated environment.
Experience using validated computerized systems to manage regulated quality records.
Proven ability to develop and implement enhancements to eQMS to improve usability, compliance, and reporting.
Strong proficiency with Microsoft Office Suite and related business applications.
Ability to manage multiple priorities in a fast-paced, evolving environment with strong attention to detail.
Highly organized, self-motivated, and capable of working independently while effectively collaborating cross-functionally.
Excellent written and verbal communication skills, with the ability to influence and interact effectively at all levels of the organization.

Senior Manager, Quality Management System, QMS

Key skills