VP, Quality

Responsibilities

• Build and Lead the Global Quality organization, ensuring proper and effective quality oversight and governance for all GxP disciplines across internal and external operations.
• Establish and uphold global quality standards for cell therapy programs, ensuring alignment with health authority requirements and industry best practices.
• Ensure product submissions, product performance, and compliance concerns are adjudicated in an effective way that is commensurate with prevailing and emerging regulatory expectations and in line with established Standards and Policies.  
• Serve as an integral member of Kyverna executive management, contributing to corporate and functional strategy. Building cross-functional relationships and representing the Quality function and quality standards on program and strategy teams.
• Ensure Quality is a strategic enabler of innovation, resource prioritization, effective risk management in line with the corporate phase of operations.
• Maintain expert, up-to-date knowledge of international GxP regulations and guidance. Serve as Kyverna’s primary point of contact with Health Authority inspectorates, leading global inspections, audits, and inspection-readiness initiatives.
• Design and implement robust, risk-based quality management systems and operations that ensure compliance across clinical trial execution, development, manufacturing, testing, and logistics operations. Develop escalation frameworks for timely and robust issue communication, management and resolution.
• Provide Quality oversight for international clinical trials, technical operations and external engagement, including due diligence, qualification, and ongoing management of Contract Manufacturing, Contract Research Organizations, and Strategic Partners. Ensure alignment with evolving regulatory expectations for cell and gene therapy products.
• Provide decisive leadership for significant compliance events, deviations, or product issues that could affect patient safety or business continuity, ensuring timely communication and effective mitigation.
• Provide strategic leadership for Inspection Readiness including vendor selection and oversight, planning and training of all cross-function team members, and preparation for inspections including key vendors and investigator sites.
• Build, mentor, and empower a high-performing Quality team with clear accountability, efficient decision-making, and an unwavering commitment to excellence.
• Partner closely with R&D, Manufacturing, Regulatory, and Commercial leaders to ensure cohesive implementation of Quality policies and timely resolution of quality-related matters.
• Represent Kyverna in global industry forums, scientific boards, and regulatory working groups to influence and shape evolving standards in cell and gene therapy regulation.

Qualifications

• Degree in Life Sciences or equivalent discipline
• 15+ years of experience in Biotech with at least 5 years leading the Quality function. 
• Prior experience with Cell Therapies is a must.
• Established track record of success supporting early and late stage CMC and clinical product development teams. Cell therapy product characterization, method bridging, comparability, control strategy experience is a plus.
• Proven track record of developing robust and agile Quality Processes and Practices for Development and Commercial operations. 
• Proven track record overseeing complex inspection readiness programs and driving successful outcomes across multiple regulatory agency inspections.
• Strong knowledge of applicable regulatory requirements, including FDA and EMA regulations and ICH guidelines, with an emphasis on requirements associated with the study of cells and tissues, particularly genetically modified cells as therapies.
• Excellent verbal, written and presentation skills to effectively communicate with all levels of management.
• Excellent leadership skills with the ability to influence and collaborate effectively across cross-functional teams.
• Strong analytical and problem-solving skills, with a focus on risk management and continuous improvement.
• Demonstrated expertise in critical thinking, influence, negotiation, problem solving, strategic thinking and leadership in a matrix environment.
• Demonstrated strong leadership capability with ability to make and act on decisions while balancing speed, quality, and risk.