Senior Director of Quality Compliance, GCP Quality, and Risk Management

Responsibilities

• Inspection readiness and management:
• 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.
• GCP Quality
• 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.
• Supplier Qualification & Vendor Management:
• 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.
•  Product Complaints:
• 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.
• Compliance Risk Management & Quality Assurance:
• Identify, assess, and manage compliance risks across internal operations and external partnerships.

Qualifications

• Degree in Life Sciences, Pharmacy, or related field. 
• 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.