Sr. Manager, Quality Systems

📋 Description

• • Kyverna Therapeutics is at the vanguard of cell therapy innovation, dedicated to developing transformative treatments for patients battling debilitating autoimmune diseases. As a clinical-stage biopharmaceutical company, we are driven by a patient-centered mission and a set of core values: Stay True to Why, Collaborate to Accelerate, Lead with Clarity, Boldly Innovative, and Own the Outcome. We are seeking a highly skilled and motivated Senior Manager, Quality Systems to join our growing team and play a pivotal role in ensuring the quality and compliance of our groundbreaking cell therapies.
• • This critical role will provide comprehensive quality expertise to support the development and eventual commercialization of Kyverna’s innovative products. You will be instrumental in ensuring adherence to all relevant US, EU, and ICH regulatory requirements, maintaining the integrity and robustness of our Quality Management System (QMS).
• • A primary focus of this position will be the active management, development, implementation, and reporting of key Quality Systems. This includes, but is not limited to, overseeing and optimizing processes for Deviations, Investigations, Corrective and Preventive Actions (CAPAs), Change Controls, Quality Metrics, and the effective utilization of our electronic Quality Management System (eQMS).
• • You will serve as a recognized subject matter expert (SME) and a trusted strategic partner to various cross-functional teams, including Technical Operations, Clinical Development, Regulatory Affairs, and others. Your insights and guidance will be crucial in shaping and executing our quality strategy.
• • The Senior Manager, Quality Systems will hold overall responsibility for the execution, scalability, and continuous improvement of Kyverna’s QMS. This involves anticipating future needs, identifying opportunities for enhancement, and implementing robust systems that can grow and mature alongside the organization.
• • You will be expected to lead and mentor team members, fostering a culture of quality excellence and continuous learning. This includes providing training, guidance, and support to ensure the team's effectiveness and professional development.
• • A key aspect of this role involves collaborating closely with internal stakeholders to identify quality risks and implement effective mitigation strategies. You will proactively assess processes and systems to ensure compliance and drive operational efficiency.
• • You will be responsible for developing and maintaining key quality documentation, including Standard Operating Procedures (SOPs), Work Instructions, and other QMS-related documents, ensuring they are current, accurate, and aligned with regulatory expectations.
• • The role requires meticulous attention to detail in reviewing and approving quality-related documents, such as batch records, validation protocols, and reports, ensuring they meet established quality standards.
• • You will actively participate in internal and external audits, including regulatory inspections, and will be responsible for coordinating responses and implementing necessary follow-up actions.
• • Driving a culture of quality is paramount. You will champion quality principles throughout the organization, promoting awareness and understanding of regulatory requirements and best practices.
• • This position offers a unique opportunity to contribute to the advancement of cutting-edge cell therapies and make a significant impact on the lives of patients with autoimmune diseases. You will be part of a dynamic and collaborative environment where innovation is encouraged and quality is paramount.
• • You will contribute to the development and implementation of quality agreements with external partners and suppliers, ensuring their compliance with Kyverna’s quality standards.
• • The Senior Manager will also be involved in the review and approval of validation strategies and reports for critical equipment, processes, and computer systems, ensuring their suitability for intended use.
• • You will monitor and analyze quality metrics to identify trends, areas for improvement, and potential risks, reporting these findings to senior management.
• • This role requires a proactive approach to problem-solving, utilizing data-driven insights to address quality issues and implement sustainable solutions.
• • Ultimately, you will be a key contributor to Kyverna’s mission, ensuring that our products are developed and manufactured to the highest quality standards, meeting the needs of the patients we serve.