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 data integrity, traceability, and compliance of quality system data in accordance with regulatory expectations.
Monitor overall quality system effectiveness, identify gaps or inefficiencies, and drive continuous improvement initiatives.
Recommend updates to quality policies and procedures and implement process improvements aligned with organizational growth and regulatory readiness.
Perform trending and data analysis to identify risks, systemic issues, and opportunities for improvement.
Create and deliver training programs related to QMS processes, data integrity, and eQMS functionality.
Support inspection readiness and ensure adherence to cGMPs, regulatory mandates, and internal quality standards.
Build and maintain strong cross-functional relationships and foster a culture of engagement, transparency, and quality ownership.

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 reviewing 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 electronic Quality Systems 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, electronic Quality Management System – eQMS

Key skills