Job | Kyverna Therapeutics Platform & Pipeline Opportunity CAR T-Cell Therapy Pipeline Clinical Trials and Expanded Access Patients Experience Stiff Person Syndrome Myasthenia Gravis Multiple Sclerosis Lupus Nephritis Systemic Sclerosis Inside Kyverna Leadership Mission & Values Education & Events Publications Videos Investors News Careers Contact --> ← Back Sr Manager, QA Operations Emeryville, CA Quality Full Time 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. Title : Sr Manager, QA Operations Location: Emeryville, CA (Hybrid) preferred. Open to remote Reports To: Sr Director, Quality Assurance Operations
Responsibilities Service as primary Quality Assurance Point of contract for Contract Development and Manufacturing Organizations (CDMOs), providing strategic quality oversight and partnership management. Provide end-to-end oversight of Quality Operations across CDMOs (Plasmid, Viral Vector, and Cell Therapy Manufacturing and Testing), including Master Batch Record review and approval, product disposition, and continuous improvement of QA operational processes. Lead batch release activities for clinical and commercial products, ensuring compliance with applicable regulatory
requirements and internal quality standards. Support Qualified Person (QP) certification activities by ensuring batches meet registered specifications, regulatory
requirements, and current GMP expectations. Review and approve OOS, OOT, deviations, supplier change notifications, change controls, and related CAPAs, ensuring timely resolution and effective implementation. Monitor and report key quality and operational metrics related to product lifecycle and product journey milestones. Support Patient Operations in the on-boarding and continued performance of the apheresis collection centers and cell therapy labs according to program plans and strategy. Ensure adherence to cGMP regulations, ICH guidelines, and Kyverna SOPs Drive and support continuous improvement initiatives to enhance quality systems, operational efficiency, compliance, and inspection readiness. Support inspection readiness, other goals, and deliverables as required.
Qualifications Bachelors or Masters in life sciences, Biology, Biochemistry, Chemical Engineering, Biotechnology or other related major. 8+ years of pharmaceutical manufacturing and/or Quality Assurance experience, with at least 2 years experience in the field of cell/gene therapies preferred. Experience with cGMP manufacturing and GDP as well as global regulatory regulations and
requirements for biopharmaceutical products and ATMPs. Strong Project Management skills and ability to manage multiple projects simultaneously. Independently motivated, detail oriented and good problem-solving ability. Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders. Domestic and international travel required, approximately 10% (including travel to CDMOs and/or Suppliers and internal business meeting, as needed). Excellent verbal, written and presentation skills and effectively communicate with all levels of management. Ability to work in a matrix environment and build strong relationships by being transparent, reliable, and delivering on commitments. The national salary range for this position is from $160K to $180K USD annually. This salary range is an estimate of what we reasonably expect to pay for this position, and the actual salary may vary based on various factors, including without limitation individual education, experience, tenure, skills and abilities, as well as internal equity and alignment with market data. This position is also eligible for
bonus,
benefits, and participation in Company’s stock plan. Apply for this job Links Home Platform & Pipeline Patients Inside Kyverna Education & Events Investors Careers Contact About Kyverna is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. Our lead CAR T-cell therapy candidate mivocabtagene (miv-cel, KYV-101), is advancing through clinical development with sponsored clinical trials across two broad areas of autoimmune disease: rheumatology and neurology, including Phase 2 trials for stiff person syndrome, multiple sclerosis, and myasthenia gravis, a Phase 1/2 trial for systemic sclerosis, and two ongoing multi-center, open-label Phase 1/2 trials in the United States and Germany for patients with lupus nephritis. Kyverna’s pipeline includes next-generation chimeric antigen receptor (CAR) T-cell therapies in both autologous and allogeneic formats with properties intended to be well suited for use in B cell-driven autoimmune diseases. FOLLOW US ON SOCIAL Privacy Policy (US) Privacy Policy (EU/UK) Designed by Elegant Themes | Powered by WordPress
Salary
$160,000 - $180,000
Location
Emeryville, CA
Total raised
$322.0M
Last stage
Public
Investors
Jeffrey Greve
Co-Founder
No applications, no recruiter spam. Just the intro.
A few questions to make sure this role is the right shape for you. Two minutes.
I write the intro, send it to the founder, and handle the back-and-forth.
If they’re a yes, I book the chat. You show up — that’s the whole job-hunt.