Hybrid Director, Quality Control

at Kyverna Therapeutics

• Job title: Director, Quality Control
• Job type: Full Time
• Experience level: Lead
• Salary: $190,000 - $220,000 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Emeryville, United States

About the role

• Leading Quality Control operations for biopharmaceutical company Kyverna Therapeutics. Overseeing compliance and strategic leadership in cell therapy development and commercialization.

Responsibilities

• Provides enterprise-level strategic and operational leadership for Quality Control activities supporting both development and commercial programs.
• Serves as the primary point of accountability for QC oversight across the organization, including outsourced testing networks, stability programs, regulatory submissions, and global inspection readiness.
• Partners closely with Technical Development, Quality Assurance, Regulatory Affairs, and other cross-functional stakeholders to ensure compliance with global regulatory requirements while enabling efficient pipeline advancement and commercial execution.
• Responsible for building and sustaining a scalable, inspection-ready QC organization.
• Drives continuous improvement across the quality system, provides strategic input into program and manufacturing decisions, and represents QC to the executive level.
• Has significant influence on regulatory outcomes, operational performance, and the overall credibility of the company’s quality function.

Requirements

• A minimum of 10 years of progressive Quality Control experience in a biotechnology or pharmaceutical environment is required.
• A Bachelor’s degree in a scientific discipline is required; a Master’s degree or advanced scientific degree is preferred.
• Demonstrated experience supporting cellular therapy and or autoimmune disease programs is required.
• Direct, hands-on involvement in IND and BLA submissions, stability program design and execution, and regulatory inspections is required.
• Strong working knowledge of global GMP regulations, outsourced laboratory oversight models, and integrated quality systems is required.
• Proven ability to lead in a matrixed, fast-paced environment, balancing strategic leadership with operational execution.
• Exceptional verbal, written, and interpersonal communication skills, with the ability to clearly convey complex scientific and regulatory information to diverse audiences.
• Demonstrated ability to independently manage multiple priorities with sound judgment, limited oversight, and a high degree of accountability.
• A collaborative leadership style with a strong track record of partnering effectively across Technical Operations, Quality, Regulatory Affairs, and other cross-functional teams.

Benefits

• Annual bonus
• Comprehensive benefits
• Participation in the Company’s stock option plan