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
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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