Kyverna Therapeutics · 1 day ago
Director, Quality Control
Emeryville, CA
Full-time
Hybrid
Director/Executive
$190K/yr - $220K/yr
10+ years expKyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. The Director, Quality Control provides strategic and operational leadership for Quality Control activities, ensuring compliance with global regulatory requirements while enabling efficient pipeline advancement and commercial execution.
BiotechnologyLife ScienceTherapeutics
Responsibilities
Establishes and maintains effective oversight of external contract testing laboratories, serving as the primary QC subject-matter expert. This includes conducting on-site evaluations to assess technical capability, compliance status, and quality performance, and ensuring alignment with internal standards and regulatory expectations
Provides direct leadership for QC contributions to regulatory submissions, including INDs and BLAs. Accountable for authoring and/or reviewing QC-related sections of submissions, with specific ownership of stability strategies, specification strategies, and batch analysis data. This includes performing gap assessments, identifying and communicating risks, and providing clear recommendations to Quality Management to support robust stability and specification programs
Manages QC inspection readiness and plays a lead role in regulatory inspections, including developing and maintaining inspection task mapping, preparing teams and partners for inspections, interfacing directly with health authorities as appropriate, and ensuring timely and effective responses to inspection findings
Serves as technical SME and provides oversight of all analytical method activities including method transfers, method qualification/validation, and compendial method verification. Reviews and approves qualification/validation protocols, executed data packages, and reports
Oversight of day-to-day activities including ensuring completion and maintenance of all required GxP, and company-mandated training; establishing recurring QC governance forums with defined agendas; ensuring accurate documentation of decisions and action items; and driving issues to resolution
Leads the development, maintenance, oversight, and continuous improvement of QC policies, procedures, processes, and tools. This includes release testing, stability program management, sample management and traceability, reference/standard program, critical reagents program, sample retains, analytical equipment qualification and maintenance, etc. across programs and lifecycle stages
Serves as main point of contact for OOS/OOT lab investigations. Provides guidance and strategy on impact, closure, and prevention
Builds, leads, and develops high-performing QC teams including setting clear expectations, mentoring senior staff, supporting succession planning, and fostering a culture of quality, accountability, and continuous improvement across both internal teams and external partners
Responsible for strategic planning related to QC staffing, capabilities, and infrastructure. This includes making recommendations on resource allocation, capital expenditures, and inspection capabilities to support current and future program needs
Prepares and delivers regular updates to the Technical Operations Leadership Team and other senior stakeholders on QC performance, metrics, trends, and risks. Following leadership alignment, the Director, QC drives execution of agreed-upon actions across Technical Operations and cross-functional teams, with clear timelines and accountability
Qualification
Required
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
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
Preferred
A Master's degree or advanced scientific degree is preferred
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
2025-12-17
Company data provided by crunchbase