Kyverna Therapeutics
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The company is pioneering CAR T-cell therapies, leveraging the transformational power of T cells to potentially provide sustained, treatment-free remission for autoimmune conditions. Kyverna's lead CAR T-cell therapy candidate, KYV-101, is advancing through clinical trials targeting various autoimmune diseases, including multiple sclerosis, myasthenia gravis, systemic sclerosis, and lupus nephritis. Their pipeline features innovative chimeric antigen receptor (CAR) T-cell therapies in both autologous and allogeneic formats aimed at B cell-driven autoimmune diseases.
cell therapy • autoimmune • lupus
Director, Quality Compliance and Risk Management
April 8
Kyverna Therapeutics
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The company is pioneering CAR T-cell therapies, leveraging the transformational power of T cells to potentially provide sustained, treatment-free remission for autoimmune conditions. Kyverna's lead CAR T-cell therapy candidate, KYV-101, is advancing through clinical trials targeting various autoimmune diseases, including multiple sclerosis, myasthenia gravis, systemic sclerosis, and lupus nephritis. Their pipeline features innovative chimeric antigen receptor (CAR) T-cell therapies in both autologous and allogeneic formats aimed at B cell-driven autoimmune diseases.
cell therapy • autoimmune • lupus
📋 Description
• Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. • The Kyverna therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells at the origin of autoimmune and inflammatory diseases. • Be at the forefront of cell therapy innovation by joining scientists, industry veterans and healthcare visionaries and help transform how autoimmune diseases are treated. • Reports to: VP GxP Quality Head • Location: Emeryville, CA (Hybrid twice a week) preferred or Remote with west coast hours. • We are seeking a Director of Quality Compliance and Risk Management to lead and evolve our global quality compliance strategy. • This role will shape the inspection readiness program, lead audits, and elevate the compliance culture across Kyverna’s development and manufacturing platforms. • You’ll be a hands-on leader who can manage high-impact initiatives, guide cross-functional partners, and build scalable quality systems in support of our growing pipeline.
🎯 Requirements
• 10+ years of experience in GxP quality compliance in the pharmaceutical or biotechnology sector, with at least 5 years in biologics or cell/gene therapy. • BS/MS/PhD in life sciences, pharmacy, or related field. • Extensive knowledge of applicable regulatory frameworks: FDA (21 CFR Parts 11, 210, 211, 600+), EMA, ICH, EudraLex Volume 4, PIC/S, and ISO/USP standards. • Skilled auditor with proven experience conducting global supplier and internal audits. • Strong understanding of biologics manufacturing, QC, and QA processes. • Demonstrated ability to lead cross-functional initiatives and mentor QA teams. • Excellent communication, analytical thinking, and project management skills. • Ability to work in a fast-paced, matrixed environment while balancing compliance, business needs, and innovation.
🏖️ Benefits
• Eligible for bonus • Participation in Company’s stock option plan
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