Director, Clinical Quality bei Kyverna Therapeutics

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.

Qualifications

• Bachelor’s degree in a scientific discipline is required
• Advanced degree in life sciences, pharmacy, or a related field preferred
• 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.