Director, Quality Compliance and Risk Management

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.

• Strategic Leadership
• Design and implement scalable, risk-based quality compliance and auditing programs across global operations operations.
• Build and lead cross-functional inspection readiness teams to ensure end-to-end regulatory preparedness.
• Define the quality roadmap to support clinical and commercial development goals.

• Audit Oversight & Risk Management
• Lead domestic and international audits of internal functions, suppliers, and contract manufacturing/testing partners.
• Manage contracted and internal auditors in the execution of the audit plan and inspection readiness activities.
• Manage all stages of the audit lifecycle: resourcing, scheduling, planning, reporting, follow-up, CAPA management, and closure.
• Conduct due diligence assessments and develop vendor risk mitigation strategies in collaboration with external quality and operations.

• Compliance Operations
• Develop and maintain systems to monitor and reduce compliance risks while ensuring data integrity.
• Ensure alignment with FDA, EMA, and ICH regulations, with a focus on advanced biologics and genetically modified cell therapies.
• Support investigations and implement corrective/preventive actions (CAPA) across the product lifecycle.

• Internal Enablement & Leadership
• Serve as a subject matter expert on global compliance requirements and industry trends.
• Guide and mentor a team of quality professionals; manage cross-functional collaboration with regulatory, clinical, technical ps, supply chain, and patient operations teams.
• Support continuous improvement of SOPs, audit templates, and training programs to mature Kyverna’s Quality Management System (QMS).

• 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.

The salary range for candidates residing in California for this position is $195,000 USD to $235,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted 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 option plan.

Kyverna is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Kyverna is committed to the principle of equal employment opportunity for all employees and does not discriminate on the basis of race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets