Director Clinical Quality

Overview reputed company 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, reputed company 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 Overview Kyverna is seeking a highly motivated Director of Clinical Quality to establish and reputed company our GCP/GLP/GPV efforts. As a Leader in the Quality Function, this individual will have clinical quality compliance reputed company for our clinical development programs both in the US and internationally, including reputed company 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 non-clinical functions and external parties including consultants, contract auditors, CROs and investigator sites to promote a high level of quality and consistency across and reputed company programs; reputed company the risk-based audit and compliance strategy for reputed company 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 reputed company, and business operations. The Director will support a culture of sustainable compliance; assist project teams in implementing corrective and preventive actions; and reputed company teams to be inspection ready. Department Quality Location Remote with reputed company coast hours Reports To Sr Dir Quality Compliance, GCP & Risk Management

Responsibilities

• Utilize advanced, international GCP expertise and management experience to reputed company, execute, and optimize cost effective, phase-appropriate, QA compliance programs
• reputed company 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 reputed company to clinical trial reputed company, site compliance and safety monitoring and reporting
• Support international clinical trials through quality reputed company, program/study team consultation, and QbD risk assessment
• reputed company and maintain the GCP audit strategy and audit plan in collaboration with program/study teams and in line with program timing and objectives. reputed company 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 reputed company timelines mandated in internal procedures
• Act as the primary reputed company of contact for regulatory agencies and reputed company 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 reputed company 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 reputed company 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
• reputed company the development, implementation, and maintenance of phase-appropriate clinical quality systems, processes, and procedures reputed company to GCP/GLP/GVP
• Foster reputed company 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-reputed company 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 reputed company field preferred
• 12+ years of experience in GCP/GLP compliance and monitoring reputed company 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 reputed company 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 reputed company and reputed company decisions while balancing speed, quality, and risk
• Strong clinical business acumen reputed company, with a focus on risk management and reputed company improvement
• Ability to work in a matrix environment and build strong relationships by being transparent, reliable, and delivering commitments

The national salary range for this position is $190,000 to $230,000 USD annually. The final compensation will be based on individual qualifications, experience, skills, internal equity, and market alignment. This position is also eligible for an annual bonus, comprehensive benefits, and participation in the Company’s stock option plan. Apply tot his job Apply To this Job