Kyverna Therapeutics · 11 hours ago
Senior Director of Quality Assurance Operations
United States
Full-time
Hybrid
Director/Executive
$240K/yr - $270K/yr
15+ years expKyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. They are seeking a Senior Director of Quality Assurance Operations to provide strategic and operational leadership for QA activities supporting the development and commercialization of Kyverna’s cell therapy portfolio, ensuring a robust quality system across GxP operations.
BiotechnologyLife ScienceTherapeutics
Responsibilities
Provide enterprise-level leadership for QA Operations supporting clinical and commercial cell and gene therapy programs
Ensure consistent, compliant execution of QA oversight across manufacturing, testing, packaging, labeling, and distribution activities
Establish and maintain a scalable, phase-appropriate QA operating model aligned with Kyverna’s growth trajectory
Ensure inspection readiness across all programs and sites; lead preparation for and management of global regulatory inspections
Provide strategic input into regulatory submissions, responses, and agency interactions related to QA operations
Serve as the primary QA point of accountability for external CMOs, CDMOs, contract laboratories, and other GxP service providers
Lead qualification, oversight, performance monitoring, and remediation of external partners, including audits and governance forums
Ensure quality agreements are in place, effective, and consistently executed
Serves as QA leader in quality-related discussions, investigations, risk assessments, change controls, etc. to resolve potential product quality issues and to ensure they are appropriately addressed and justified
Provides QA compliance expertise and guidance in conducting investigations in regards to quality deviations, laboratory investigations, change controls, etc
Partner closely with CMC, Manufacturing, Technical Development, Supply Chain, Clinical Operations, and Regulatory Affairs to enable compliant and efficient execution
Provide quality leadership in program, manufacturing, and operational decision-making, balancing risk, compliance, and speed
Influence and lead by example as a quality advocate while maintaining a pragmatic, solutions-oriented mindset
Drive process optimization, digital enablement, and standardization across QA Operations
Identify and mitigate quality and compliance risks proactively
Contribute to Quality and company-level strategic planning initiatives
Qualification
Required
Bachelor's degree in a scientific or engineering discipline; advanced degree preferred
15+ years of progressive experience in Quality Assurance within biotech or pharmaceutical environments
Demonstrated experience supporting clinical and commercial manufacturing, preferably in cell and gene therapy or other advanced modalities
Deep knowledge of global GxP regulations and expectations, including FDA, EMA, and ICH
Proven track record of leading QA oversight of external manufacturing and testing partners
Experience building and scaling QA operations in a growing organization
Strong inspection management experience with a history of successful regulatory outcomes
Experience supporting both late-stage development and commercial launch
Strategic thinker with strong operational execution capabilities
Credible, confident quality leader who can influence at senior and executive levels
Pragmatic and risk-based decision-maker with sound judgment
Benefits
Annual bonus
Comprehensive benefits
Participation in the Company’s stock option plan
Company
Kyverna Therapeutics
Kyverna Therapeutics is pioneering a new class of therapies and cures for serious autoimmune diseases.
51-200 employees
H1B Sponsorship
Kyverna Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2023 (1)
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$295MKey Investors
Oxford Finance LLCNorthpond Ventures
2025-12-17Post Ipo Equity· $100M
2025-11-03Post Ipo Debt· $25M
2024-02-08IPO
Leadership Team
Marc Grasso
Chief Financial Officer
Tom Van Blarcom
Senior Vice President, Head of Research
Recent News
2026-01-02
Company data provided by crunchbase