Senior Director of Quality Assurance Operations
Kyverna Therapeutics
full-time
Posted on:
Location Type: Remote
Location: California • United States
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Salary
💰 $240,000 - $270,000 per year
Job Level
About the role
- 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.
Requirements
- 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
- Eligible for an 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 AssuranceGxP regulationsFDAEMAICHregulatory submissionsquality investigationsrisk assessmentsprocess optimizationQA oversight
Soft skills
leadershipstrategic thinkingoperational executioninfluencepragmatic decision-makingsolutions-oriented mindsetcommunicationcollaborationproblem-solvingrisk management