Director, Clinical Quality
Kyverna
- Emeryville, CA
- Permanent
- Full-time
- Utilize advanced, international GCP expertise and management experience to develop, execute, and optimize cost effective, risk-based, quality assurance and compliance programs.
- Develop and implement a strategic vision for GCP/GLP Quality Assurance to align with business objectives. Design and build the GCP/GLP Quality Unit.
- Drive the execution of a scalable, cost effective, and risk-based quality assurance 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 risk assessment.
- Participate in Site activation, initiation and qualification activities as required.
- 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.
- Plan/strategize inspection readiness activities to support program/study team.
- Establish and manage a robust quality management system to support clinical operations including developing and implementing policies, procedures, and processes that align with industry best practices and regulatory requirements. Continuously evaluate and enhance the quality systems to drive efficiency and compliance. ยท Lead investigations into significant quality issues related to GCP elements, product handling, administration, or safety. Facilitate identification of root cause, and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities.
- Oversee the development, implementation, and maintenance of quality systems, processes, and procedures related to GCP/GLP and clinical trial oversight.
- Recruit, train, and mentor a high-performing team of quality assurance professionals.
- 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 legislation and relevant parts of GxP guidelines, requirements and practices and ensure that the information is integrated into the Quality and Operating processes within Kyverna and the organizations supporting clinical development.
- Advanced degree in life sciences, pharmacy, or a related field.
- Minimum of 10 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 cells and tissues, particularly genetically modified cells as therapies.
- Proven track record in developing and implementing quality systems 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 environment.
- Demonstrated strong leadership capability with ability to make and act on decisions while balancing speed, quality, and risk.
- 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 ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives.
- Ability to work in a matrix environment and build strong relationships by being transparent, reliable, and delivering on commitments.
- Self-starter, works effectively in teams.