Kyverna Therapeutics · 3 hours ago
Director, Clinical Quality
Emeryville, CA
Full-time
Hybrid
Director/Executive
$190K/yr - $230K/yr
12+ years expKyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. They are seeking a highly motivated Director of Clinical Quality to establish and lead GCP/GLP/GPV efforts, ensuring compliance and quality in clinical development programs. The role involves collaboration with internal and external parties to promote high standards of quality and consistency across programs.
BiotechnologyLife ScienceTherapeutics
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 and support to these teams on quality-related matters
Maintain expert up-to-date knowledge on GCP/GVP/GLP legislation/guidelines, requirements and practices. Ensure that the information is integrated into Kyverna Clinical Development processes and procedures
Qualification
Required
Bachelor's degree in a scientific discipline is required
12+ years of experience in GCP/GLP compliance and monitoring within the biotechnology or pharmaceutical industry, with a focus on autologous and allogeneic cell therapy treatments preferred
Strong knowledge of applicable regulatory requirements, including FDA and EMA regulations and ICH guidelines, with an emphasis on requirements associated with the study of ATMPs, particularly genetically modified cells as therapies
Proven track record in maturing/managing phase-appropriate, risk-based clinical QMS (e.g. ICH E6 (R3), QbD) and processes in a clinical setting
Successful management of audits and inspections by regulatory agencies
Excellent verbal, written and presentation skills to effectively communicate with all levels of management
Demonstrated expertise in critical thinking, influence, negotiation, problem solving, strategic thinking and leadership in a matrix, cross-functional environment
Demonstrated strong leadership capability with ability to make and act on decisions while balancing speed, quality, and risk
Strong clinical business acumen skill, with a focus on risk management and continuous improvement
Ability to work in a matrix environment and build strong relationships by being transparent, reliable, and delivering commitments
Preferred
Advanced degree in life sciences, pharmacy, or a related field preferred
Strong knowledge of applicable regulatory requirements, including FDA and EMA regulations and ICH guidelines, with an emphasis on requirements associated with the study of ATMPs, particularly genetically modified cells as therapies
Benefits
Annual bonus
Comprehensive benefits
Participation in the Company’s stock option plan
Company
Kyverna Therapeutics
Kyverna Therapeutics is pioneering a new class of therapies and cures for serious autoimmune diseases.
51-200 employees
H1B Sponsorship
Kyverna Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2023 (1)
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$295MKey Investors
Oxford Finance LLCNorthpond Ventures
2025-12-17Post Ipo Equity· $100M
2025-11-03Post Ipo Debt· $25M
2024-02-08IPO
Leadership Team
Marc Grasso
Chief Financial Officer
Tom Van Blarcom
Senior Vice President, Head of Research
Recent News
2026-01-16
Company data provided by crunchbase