Senior Director of Quality Assurance Operations

Responsibilities

• QA Operations Leadership
• 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.
• External Partner Oversight
• 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.
• Cross-Functional Partnership
• 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.
• Continuous Improvement and Strategy
• 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.

Qualifications

• 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.