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This position was posted on May 3, 2026 and is likely no longer accepting applications. We've kept it here for historical reference. Check out the similar jobs below!
Job Overview
Location
Remote
Job Type
Full-time
Category
Product Management
Date Posted
May 3, 2026
Full Job Description
đź“‹ Description
- • Senior Specialist, Quality Assurance Operations (Contract) – A critical role supporting Kyverna Therapeutics’ mission to develop cell therapies for autoimmune diseases by ensuring compliance with US, EU, and ICH regulatory standards during product development and commercialization.
- • Day-to-day responsibilities include providing quality expertise to support QA Operations, executing batch record review and disposition activities, contributing to continuous improvement of QA processes, and collaborating closely with cross-functional teams to maintain regulatory compliance.
- • Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company guided by core values: Stay True to Why, Collaborate to Accelerate, Lead with Clarity, Boldly Innovative, and Own the Outcome, dedicated to transforming treatment for autoimmune diseases through innovative cell therapies.
- • In this role, the Sr. Specialist will deepen expertise in pharmaceutical quality systems, regulatory compliance (FDA, EMA, ICH), batch record management, and cross-functional collaboration within a growing biotech organization, gaining hands-on experience in early-stage cell therapy development and commercialization readiness.
🎯 Requirements
- • Bachelor’s degree in Life Sciences, Chemistry, Engineering, or related field
- • Minimum 3+ years of experience in Quality Assurance within pharmaceutical, biotechnology, or medical device industries
- • Strong knowledge of cGMP, ICH guidelines, FDA 21 CFR Part 210/211, and EU GMP regulations
- • Experience with batch record review, deviation management, and change control systems
- • Ability to work remotely or hybrid (Emeryville, CA) for a 6+ month contract
- • Excellent communication and collaboration skills for cross-functional team engagement
🏖️ Benefits
- • Competitive hourly rate of $55–$65/hour (National)
- • Fully remote or hybrid work option (Emeryville, CA)
- • Opportunity to contribute to cutting-edge cell therapy development for autoimmune diseases
- • Exposure to global regulatory frameworks (US, EU, ICH) in a fast-growing clinical-stage biotech
- • Collaborative, mission-driven culture aligned with Kyverna’s core values
- • Professional growth in QA Operations within a specialized biopharmaceutical niche
Skills & Technologies
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About Kyverna Therapeutics, Inc.
Kyverna Therapeutics is a clinical-stage cell-therapy company developing engineered Treg and CAR-T cell treatments for autoimmune diseases. It combines synthetic biology with cellular engineering to create next-generation regulatory T cells that selectively suppress pathologic immune activity. Its lead candidate, KYV-101, is an autologous CD19 CAR-Treg therapy in Phase 1/2 trials for lupus nephritis and systemic sclerosis. Headquartered in Emeryville, California, Kyverna operates a cGMP manufacturing facility and is advancing a pipeline of programmable cell therapies aimed at resetting immune tolerance in chronic inflammatory disorders.
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