Kyverna is seeking an experienced Senior Director of Quality Compliance, GCP Quality, and Risk Management to establish scalable, risk-based quality infrastructure to ensure operational excellence, compliance, and inspection readiness across Kyverna’s clinical and operational activities.
Requirements
- Develop program to track, monitor and report inspection readiness activities, their status and residual risk.
- Identify resources and timing for performing mock inspections both for Kyverna and external parties (CDMOs, CROs, Clinical sites, suppliers)
- Manage and report on progress of findings and remediation activities.
- Develop process for responding to inspection findings and archiving the inspection history information.
- Develop inspection management process for Kyverna Health Authority inspections including needed roles, organization of inspection process, training of SMEs and inspection-related roles, document handling and information sharing processes.
- Develop notification and escalation procedures for information exchange including notification and management of Health Authority Inspections and outcomes.
- Lead mock inspections of external parties and the resulting follow-up
- Continue to mature inspection process for Kyverna in line with Business Maturity.
- Provide GCP quality oversight across CAR-T clinical programs, ensuring patient safety, data integrity, and compliance.
- Develop and implement a strategic vision for GCP/GLP Quality Assurance to align with business objectives.
- Design and build the GCP/GLP Quality Unit.
- Lead GCP audits of clinical sites, CROs, and associated vendors.
- Drive global inspection readiness for CAR-T and ATMP regulatory expectations; serve as key inspection lead.
- Oversee quality at the manufacturing–clinical interface including apheresis, cell processing, release, and infusion steps.
- Provide GCP Quality safety oversight including documentation and quality control of CRS, ICANS, and long-term follow-up requirements.
- Mature processes and provide leadership for deviation investigations, root cause analyses, and CAPA management for GCP and CAR-T related issues.
- Deliver GCP and CAR-T specific training to internal teams, investigators, and apheresis/treatment sites.
- Develop and implement a supplier qualification strategy to assess and monitor external partners, contract manufacturing organizations (CMOs), and contract service providers (CSPs).
- Create a risk-based audit and supplier assessment strategy to support clinical program timelines and operational goals.
- Lead supplier qualification audits and manage internal and external auditors to ensure compliance with GxP and regulatory requirements.
- Collaborate with procurement, manufacturing, and technical teams to evaluate supplier performance and support vendor risk management processes.
- Establish and maintain supplier quality agreements, defining expectations for compliance and quality standards.
- Independently manage domestic and international audits and lead efforts for continuous improvement of quality systems.
- Develop and manage system for monitoring product complaints
- Establish mechanism for integrating medical and technical assessments where warranted and manage the reporting timing
- In collaboration with other stakeholders ensure timely adjudication of customer complaints.
- Track and trend complaints by type to ensure no hidden trends exist.
- Establish and administer the product recall process. In collaboration with other stakeholder groups, ensure the Product Recall process is robust and timely.
- Identify, assess, and manage compliance risks across internal operations and external partnerships.
- Qualify Life Sciences, Pharmacy, or related field degree with 15+ years in GxP compliance and quality management within the biotechnology or pharmaceutical industry.
- 8+ years of inspection readiness and management is a must
- Experience with autologous/allogeneic cell therapy or genetically modified products is strongly preferred.
- In-depth knowledge of international GMP and GCP regulations and ICH guidelines, particularly those related to cell-based therapies.
- Track record of managing quality systems across product lifecycles, including preparation for health authority inspections.
- Strong leadership in matrix environments with experience influencing cross-functional teams.
- Expertise in problem-solving, strategic thinking, and risk management.
- Exceptional verbal and written communication, with the ability to present complex topics to stakeholders at all levels.
- Self-starter who thrives in collaborative environments, with the ability to build strong relationships based on trust and transparency.
Benefits
- Bonus
- Benefits
- Participation in Company’s stock option plan
