Sr. Manager, Quality Management System (QMS)

About the company

Kyverna Therapeutics is a patient-focused biopharmaceutical company at the clinical stage, building cell therapies for people living with autoimmune diseases. The organization is driven by a set of core values centered on purpose, collaboration, innovation, accountability, and clarity, and it aims to advance the future of autoimmune disease treatment.

This role is for a Senior Manager, Quality Management System (QMS), who will contribute quality expertise to support the development and eventual commercialization of the company’s products in line with applicable US, EU, and ICH standards. The position will own and improve core quality systems, including deviations, investigations, CAPAs, change control, quality metrics, and the electronic quality management system (eQMS), while partnering across Technical Operations, Clinical, Regulatory Affairs, and other teams as the company scales.

Role overview

The Senior Manager will function as both a subject matter expert and a cross-functional partner, helping ensure the quality system is effective, scalable, inspection-ready, and continuously improving as the organization grows.

Key responsibilities

• Own and maintain the procedures, SOPs, and workflows that support deviations, investigations, CAPAs, change controls, quality metrics, and other foundational QMS processes.
• Provide quality oversight for IT systems that support GxP-related activities.
• Lead or assist with the setup, validation, configuration, and ongoing optimization of the eQMS, with attention to stage-appropriate design and future scalability.
• Work directly within the eQMS to review, process, and manage quality records in day-to-day operations.
• Collaborate with internal teams to define data governance requirements, system settings, user access, and reporting needs for quality systems.
• Protect data integrity, traceability, and compliance of quality records in line with regulatory expectations, including ALCOA+ principles.
• Track QMS performance, identify inefficiencies or gaps, and lead improvement efforts.
• Recommend revisions to quality policies and procedures and implement process enhancements that support growth and regulatory readiness.
• Build, analyze, and present quality metrics and KPIs for routine quality review meetings.
• Perform trend analysis and data reviews to surface risks, recurring issues, and improvement opportunities.
• Develop and conduct training on QMS processes, data integrity, and eQMS usage.
• Support inspection readiness and help ensure compliance with cGMP expectations, regulatory requirements, and internal quality standards.
• Strengthen collaboration across functions and help foster a culture of transparency, engagement, and ownership for quality.
• Complete additional tasks as assigned.

Requirements

• A bachelor’s degree in Computer Science, Life Sciences, or a closely related discipline, or equivalent practical experience.
• Proven experience implementing, running, and improving an eQMS, including configuration, validation support, and lifecycle management.
• At least 8 years of experience in pharma or biotech, with 6 or more years focused on Quality Systems or Quality Assurance.
• Solid understanding of quality data management, reporting, and data integrity principles.
• Direct experience handling deviations, investigations, CAPAs, and change controls in a regulated setting.
• Experience working with validated computerized systems for regulated quality records.
• Demonstrated ability to enhance eQMS functionality to improve compliance, usability, and reporting.
• Strong command of Microsoft Office and related business tools.
• Ability to juggle multiple priorities in a fast-moving environment while maintaining strong attention to detail.
• Well organized, self-directed, and effective both independently and in cross-functional settings.
• Excellent written and verbal communication skills, with the ability to influence stakeholders at all levels.

Location and reporting

This position reports to the Sr. Director, Quality Systems. The role is based in Emeryville, CA with a hybrid schedule of two days per week onsite, or it may be performed remotely if eligible.

Compensation and benefits

The estimated national salary range for this role is USD 160,000 to USD 180,000 per year. Final pay may differ depending on education, experience, tenure, skills, abilities, internal equity, and market alignment. The role is also eligible for a bonus, benefits, and participation in the company stock plan.