Director of Quality Compliance

Director of Quality Compliance

Kyverna is seeking an experienced Director of Quality Compliance and Risk Management. In this leadership role, you will establish scalable, risk-based quality infrastructure to ensure operational excellence, compliance, and inspection readiness across Kyverna's clinical and operational activities. The role offers the opportunity to support supplier oversight, and collaborate across functions to ensure consistent, high-quality performance aligned with global regulatory standards. If you're passionate about transforming patient care through innovative therapies, join us and help advance life-changing treatments for autoimmune diseases.

Title : Director of Quality Compliance

Location : Emeryville, CA (Hybrid twice a week) OR Remote west coast hours

Travel : up to 20%

Responsibilities :

• Inspection readiness and management :
• Develop program to track, monitor and report inspection readiness activities, their status and residual risk.
• Identify resources and timing for performing mock inspections both for Kyverna and external parties (CDMOs, CROs, Clinical sites, suppliers)
• Manage and report on progress of findings and remediation activities. Develop process for responding to inspection findings and archiving the inspection history information.
• Develop inspection management process for Kyverna Health Authority inspections including needed roles, organization of inspection process, training of SMEs and inspection-related roles, document handling and information sharing processes.
• Develop notification and escalation procedures for information exchange including notification and management of Health Authority Inspections and outcomes.
• Lead mock inspections of external parties and the resulting follow-up
• Continue to mature inspection process for Kyverna in line with Business Maturity.
• Supplier Qualification & Vendor Management :
• Develop and implement a supplier qualification strategy to assess and monitor external partners, contract manufacturing organizations (CMOs), and contract service providers (CSPs).
• Create a risk-based audit and supplier assessment strategy to support clinical program timelines and operational goals.
• Lead supplier qualification audits and manage internal and external auditors to ensure compliance with GxP and regulatory requirements.
• Collaborate with procurement, manufacturing, and technical teams to evaluate supplier performance and support vendor risk management processes.
• Establish and maintain supplier quality agreements, defining expectations for compliance and quality standards.
• Independently manage domestic and international audits and lead efforts for continuous improvement of quality systems.
• Product Complaints :
• Develop and manage system for monitoring product complaints
• Establish mechanism for integrating medical and technical assessments where warranted and manage the reporting timing
• In collaboration with other stakeholders ensure timely adjudication of customer complaints.
• Track and trend complaints by type to ensure no hidden trends exist.
• Establish and administer the product recall process. In collaboration with other stakeholder groups, ensure the Product Recall process is robust and timely.
• Compliance Risk Management & Quality Assurance :
• Identify, assess, and manage compliance risks across internal operations and external partnerships.

Qualifications :

The salary range for this position in Northern California is from $200,000 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.