Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, Stay True to Why, Collaborate to Accelerate, Lead with Clarity, Boldly Innovative, and Own the Outcome, we are committed to transforming the future of treatment for autoimmune disease. Join us at the forefront of cell therapy innovation and help redefine what’s possible.
We are seeking a Senior Manager, Quality Management System (QMS) to provide quality expertise supporting the development and commercialization of Kyverna’s products in compliance with relevant US, EU, and ICH requirements. This role will be responsible for actively managing, developing, implementing, and reporting on Quality Systems, including Deviations, Investigations, CAPAs, Change Controls, Quality Metrics, and electronic Quality Management Systems (eQMS). The Senior Manager, Quality Management System will serve as a subject matter expert and strategic partner across Technical Operations, Clinical, Regulatory Affairs, and other cross-functional teams, with overall responsibility for the execution, scalability, and continuous improvement of Kyverna’s Quality Management System as the organization grows and matures.
Title: Sr. Manager, Quality Management System (QMS)
Reports to: Sr. Director, Quality Systems
Location: Emeryville, CA (Hybrid – twice a week) or Remote Eligible
Responsibilities
- Manage and maintain processes, SOPs, and workflows for Deviations, Investigations, CAPA, Change Control, Quality Metrics, and other core QMS programs.
- Provide QA oversight of Information Technology systems supporting GxP processes.
- Lead or support the implementation, configuration, validation, and optimization of the electronic Quality Management System (eQMS), ensuring phase-appropriate design and scalability.
- Provide hands-on expertise in the day-to-day execution, review, and management of QMS records within the eQMS.
- Partner with internal stakeholders to define data governance, system configuration, user roles, and reporting requirements for quality systems.
- Ensure data integrity, traceability, and compliance of quality system data in accordance with regulatory expectations (e.g., ALCOA+ principles).
- Monitor overall QMS 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.
- Develop, compile, analyze, and present quality metrics and KPIs for routine quality management review.
- 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.
- Perform other duties as assigned.
Qualifications
- 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.
Skills Required
- Bachelor's degree in Computer Science, Life Sciences, or related field, or equivalent relevant experience.
- Minimum of 8 years in the pharmaceutical or biotechnology industry, including 6+ years in Quality Systems / Quality Assurance.
- Demonstrated experience implementing, administering, and improving an eQMS, including system configuration, validation support, and lifecycle management.
- 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.
- Strong working knowledge of quality system data management, reporting, and data integrity principles (e.g., ALCOA+).
- Proven ability to develop and implement enhancements to eQMS to improve usability, compliance, and reporting.
- Provide QA oversight of IT systems supporting GxP processes and ensure data integrity and traceability.
- Strong proficiency with Microsoft Office Suite and related business applications.
- Excellent written and verbal communication skills and ability to collaborate cross-functionally.
What We Do
Kyverna is a cell therapy company engineering and developing a new class of curative living medicines for inflammatory and autoimmune diseases. Using its SmarTcell™ approach which includes synReg-T cell and synNotch CAR-T technology platforms, Kyverna reprograms T cells to target and selectively suppress or eliminate autoreactive immune cells. The company’s goal is to develop therapies that are selective, potent and durable to tame autoimmunity. We build interdisciplinary teams that bring a broad range of experiences and scientific expertise together to develop medicines that will free patients from the siege of autoimmune diseases and bring curiosity for exploring and creating the unknown. Our commitment to our employees is to foster an open, supportive, and inclusive environment where we create opportunities for individuals to learn and grow to their full potential at every level. synNotch is a trademark of Gilead/Kite.
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