Senior Director of Quality Compliance, GCP Quality, and Risk Management at Kyverna Therapeutics

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Full Time

Start Date

Immediate

Expiry Date

14 Mar, 26

Salary

250000.0

Posted On

14 Dec, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Compliance, Risk Management, GCP Quality, Inspection Readiness, Supplier Qualification, Vendor Management, Auditing, Regulatory Compliance, Data Integrity, Patient Safety, Problem-Solving, Strategic Thinking, Leadership, Communication, Collaboration, Continuous Improvement

Industry

Biotechnology Research

Description

Kyverna is seeking an experienced Senior Director of Quality Compliance, GCP Quality, and Risk Management. In this leadership role, you will establish scalable, risk-based quality infrastructure to ensure operational excellence, compliance, and inspection readiness across Kyverna’s clinical and operational activities. In addition, this role provides GCP quality oversight across CAR-T clinical programs, ensuring patient safety, data integrity, and compliance. The role offers the opportunity to support supplier oversight, and collaborate across functions to ensure consistent, high-quality performance aligned with global regulatory standards. If you're passionate about transforming patient care through innovative therapies, join us and help advance life-changing treatments for autoimmune diseases. Title: Senior Director of Quality Compliance Location: Emeryville, CA (Hybrid twice a week) OR Remote west coast hours Travel: up to 25% \n 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. \n The national salary range for this position is from $220,000 to $250,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position, and the actual salary may vary based on various factors, including without limitation individual education, experience, tenure, skills and abilities, as well as internal equity and alignment with market data. This position is also eligible for bonus, benefits, and participation in Company’s stock option plan.

Responsibilities

The Senior Director will establish a scalable quality infrastructure to ensure compliance and operational excellence across clinical activities. Responsibilities include managing inspection readiness, providing GCP quality oversight, and developing supplier qualification strategies.