Director, Quality Control
Kyverna Therapeutics
full-time
Posted on:
Location Type: Hybrid
Location: Emeryville • California • United States
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Salary
💰 $190,000 - $220,000 per year
Job Level
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Quality Controlcellular therapyautoimmune disease programsIND submissionsBLA submissionsstability program designregulatory inspectionsglobal GMP regulationsoutsourced laboratory oversightintegrated quality systems
Soft skills
strategic leadershipoperational executionverbal communicationwritten communicationinterpersonal communicationcollaborative leadershipability to manage multiple prioritiessound judgmenthigh accountabilitypartnering effectively