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KY
Director, Clinical Quality
KyvernaEmeryville, United Statesfull_timeVerifiedPosted 26 Jan 2026
💰 $230,000/yr($190,000/yr – $230,000/yr)
About the role
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.
Position OverviewKyverna is seeking a highly motivated Director of Clinical Quality to establish and lead our GCP/GLP/GPV efforts. As a Leader in the Quality Function, this individual will have clinical quality compliance oversight for our clinical development programs both in the US and internationally, including oversight of contract labs supporting clinical studies and non-clinical studies, ensuring our adherence to regulatory requirements, and maintaining the highest standards of quality in our clinical development programs. This position will collaborate with internal clinical and nonclinical functions and external parties including consultants, contract auditors, CROs and investigator sites to promote a high level of quality and consistency across and within programs; develop the risk-based audit and compliance strategy for all programs. Additionally, this position will independently manage domestic and international risk-based audits of; investigator sites, study documents, databases, vendors, partners, and internal systems in compliance with GCP, GLP, and Company policies and procedures; assess impact of audit findings on subject safety, data integrity, and business operations. The Director will support a culture of sustainable compliance; assist project teams in implementing corrective and preventive actions; and enable teams to be inspection ready.
Department: QualityLocation: Remote with West coast hoursReports To: Sr Dir Quality Compliance, GCP & Risk Management
Position OverviewKyverna is seeking a highly motivated Director of Clinical Quality to establish and lead our GCP/GLP/GPV efforts. As a Leader in the Quality Function, this individual will have clinical quality compliance oversight for our clinical development programs both in the US and internationally, including oversight of contract labs supporting clinical studies and non-clinical studies, ensuring our adherence to regulatory requirements, and maintaining the highest standards of quality in our clinical development programs. This position will collaborate with internal clinical and nonclinical functions and external parties including consultants, contract auditors, CROs and investigator sites to promote a high level of quality and consistency across and within programs; develop the risk-based audit and compliance strategy for all programs. Additionally, this position will independently manage domestic and international risk-based audits of; investigator sites, study documents, databases, vendors, partners, and internal systems in compliance with GCP, GLP, and Company policies and procedures; assess impact of audit findings on subject safety, data integrity, and business operations. The Director will support a culture of sustainable compliance; assist project teams in implementing corrective and preventive actions; and enable teams to be inspection ready.
Department: QualityLocation: Remote with West coast hoursReports To: Sr Dir Quality Compliance, GCP & Risk Management
Responsibilities
- Utilize advanced, international GCP expertise and management experience to develop, execute, and optimize cost effective, phase-appropriate, QA compliance programs.
- Develop and implement a strategic vision for GCP/GLP/GVP Quality Assurance to align with business objectives.
- Drive the execution of a scalable, cost effective, and phase-appropriate QA and compliance infrastructure related to clinical trial oversight, site compliance and safety monitoring and reporting.
- Support international clinical trials through quality oversight, program/study team consultation, and QbD risk assessment.
- Develop and maintain the GCP audit strategy and audit plan in collaboration with program/study teams and in line with program timing and objectives. Perform vendor and clinical site evaluations, as required.
- Collaborate with cross-functional teams to address findings and implement corrective and preventive actions. Maintain and update the CAPA process to ensure the audit reports and corrective actions are developed and completed within timelines mandated in internal procedures.
- Act as the primary point of contact for regulatory agencies and lead GCP health authority audits and inspections. Implement Inspection Readiness program and provide leadership for GCP inspection readiness training and preparation for MOCK BIMO interview/audits and provide GCP compliance technical support during inspections of investigator sites. Participate in regulatory agency inspections.
- Represent QA in Program Teams, sub-teams and study teams, where relevant and provide input, guidance, and oversight to ensure clinical trials are conducted in compliance with clinical protocols, GCP and other regulatory requirements.
- Enhance and manage a phase-appropriate Clinical QMS to support clinical operations including collaborating on policies, procedures, and processes that align with industry’s best practices and regulatory requirements. Continuously evaluate and enhance the QMS to drive efficiency and compliance.
- Provide compliance direction on investigations into significant quality issues related to GCP elements, product handling, administration, or safety. Facilitate identification of root cause, and development of effective corrective and preventive actions. Ensure reporting of potential or confirmed violations to regulatory authorities in collaboration with Clinical Operations and RA management.
- Oversee the development, implementation, and maintenance of phase-appropriate clinical quality systems, processes, and procedures related to GCP/GLP/GVP.
- Foster close collaboration with clinical development, regulatory affairs, clinical operations, patient operations, medical affairs, and other departments to ensure alignment and coordination in quality compliance activities. Provide guidance
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