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.
Position Summary
Kyverna is seeking a Senior Director of Quality Assurance Operations to provide strategic and operational leadership for QA activities supporting the development and commercialization of Kyverna’s cell therapy portfolio. This role is accountable for ensuring a robust, inspection-ready quality system across GxP operations, including clinical and commercial manufacturing, external partners, and global supply chain activities.
The Senior Director, QA Operations serves as a key member of the Quality leadership team and a trusted partner to Technical Development, Manufacturing, CMC, Regulatory Affairs, Clinical Operations, and Supply Chain. This leader will build and scale QA operational capabilities, drive continuous improvement, and ensure compliance with global regulatory expectations while enabling efficient and timely program execution.
Job Title: Senior Director, Quality Assurance Operations
Reports To: Vice President, Quality
Location: Hybrid (Emeryville, CA) or Remote Eligible
ResponsibilitiesQA Operations LeadershipProvide enterprise-level leadership for QA Operations supporting clinical and commercial cell and gene therapy programs.Ensure consistent, compliant execution of QA oversight across manufacturing, testing, packaging, labeling, and distribution activities.Establish and maintain a scalable, phase-appropriate QA operating model aligned with Kyverna’s growth trajectory.Ensure inspection readiness across all programs and sites; lead preparation for and management of global regulatory inspections.Provide strategic input into regulatory submissions, responses, and agency interactions related to QA operations.
External Partner OversightServe as the primary QA point of accountability for external CMOs, CDMOs, contract laboratories, and other GxP service providers.Lead qualification, oversight, performance monitoring, and remediation of external partners, including audits and governance forums.Ensure quality agreements are in place, effective, and consistently executed.Serves as QA leader in quality-related discussions, investigations, risk assessments, change controls, etc. to resolve potential product quality issues and to ensure they are appropriately addressed and justified.Provides QA compliance expertise and guidance in conducting investigations in regards to quality deviations, laboratory investigations, change controls, etc.
Cross-Functional PartnershipPartner closely with CMC, Manufacturing, Technical Development, Supply Chain, Clinical Operations, and Regulatory Affairs to enable compliant and efficient execution.Provide quality leadership in program, manufacturing, and operational decision-making, balancing risk, compliance, and speed.Influence and lead by example as a quality advocate while maintaining a pragmatic, solutions-oriented mindset.
Continuous Improvement and StrategyDrive process optimization, digital enablement, and standardization across QA Operations.Identify and mitigate quality and compliance risks proactively.Contribute to Quality and company-level strategic planning initiatives.QualificationsBachelor’s degree in a scientific or engineering discipline; advanced degree preferred.15+ years of progressive experience in Quality Assurance within biotech or pharmaceutical environments.Demonstrated experience supporting clinical and commercial manufacturing, preferably in cell and gene therapy or other advanced modalities.Deep knowledge of global GxP regulations and expectations, including FDA, EMA, and ICH.Proven track record of leading QA oversight of external manufacturing and testing partners.Experience building and scaling QA operations in a growing organization.Strong inspection management experience with a history of successful regulatory outcomes.Experience supporting both late-stage development and commercial launch.Strategic thinker with strong operational execution capabilities.Credible, confident quality leader who can influence at senior and executive levels.Pragmatic and risk-based decision-maker with sound judgment.The national salary range for this position is $240,000 to $270,000 USD annually. The final compensation will be based on individual qualifications, experience, skills, internal equity, and market alignment. This position is also eligible for an annual bonus, comprehensive benefits, and participation in the Company’s stock option plan.
