Why This Job is Featured on The SaaS Jobs
Quality operations roles are a useful lens into how regulated, innovation-led companies operationalise “release-ready” work. Although this listing sits in clinical-stage therapeutics rather than a classic SaaS product org, the underlying operating model will feel familiar to SaaS professionals who have worked in governance-heavy environments where auditability, traceability, and controlled change are central to delivery.
For a career built around SaaS, the transferable value is the discipline behind scalable operations: structured documentation, exception handling, and tight feedback loops across functions. Work spanning batch record review, disposition, and quality system processes builds muscle in risk-based decision making and process optimisation, which maps well to SaaS domains like compliance programs, platform operations, and regulated customer workflows. The contract format also signals concentrated exposure to execution cadence and measurable throughput.
This role best suits professionals who prefer detail-oriented work, clear standards, and cross-functional coordination over open-ended product exploration. It aligns with someone comfortable owning reviews end to end, escalating issues with precision, and improving systems incrementally. Remote or hybrid setup points to a working style that values written communication and disciplined follow-through across distributed stakeholders.
The section above is editorial commentary from The SaaS Jobs, provided to help SaaS professionals understand the role in a broader industry context.
Job Description
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, Stay True to Why, Collaborate to Accelerate, Lead with Clarity, Boldly Innovative, and Own the Outcome, we are committed to transforming the future of treatment for autoimmune disease. Join us at the forefront of cell therapy innovation and help redefine what's possible.
Position Summary
We are seeking a Sr. Specialist, Quality Assurance Operations (QA Ops) for a temporary assignment. The Sr. Specialist will provide quality expertise to support QA Operations in the development and commercialization of Kyverna’s products, ensuring compliance with applicable US, EU, and ICH regulatory requirements. The Sr. Specialist will contribute to the execution and continuous improvement of QA Operations as the organization continues to grow and evolve. This role requires strong collaboration with cross-functional teams, particularly in supporting batch record review and disposition activities.
Title: Senior. Specialist, Quality Assurance Operations (Contract)
Reports to: Sr Director, Quality Assurance Operations
Location: Remote or Hybrid (Emeryville, CA)
Duration: 6+ Months
Hourly Rate: $55–$65/hour (National)
Responsibilities
- Review executed batch records and associated documentation for accuracy and compliance
- Support batch release and disposition activities
- Must consistently meet production schedule release timelines
- Ability to identify and escalate issues to Quality Management
- Provide quality guidance on documentation discrepancies and compliance issues
- Maintain and update vendor change notifications tracker
- Assist with quality system processes, including deviations, change controls, CAPAs, and vendor change notifications
- Ensure adherence to cGMP regulations, ICH guidelines, and Kyverna SOPs
- Contribute to quality system enhancements and continuous process improvement initiatives
- Perform additional duties as assigned
Qualifications
- Bachelor’s degree in a life sciences discipline (e.g., biology, immunology, biochemistry) or equivalent experience
- Minimum of 6 years of experience in Quality Assurance or a related role within biotech, pharmaceutical, or cell/gene therapy industries
- Strong ability to manage multiple priorities in a fast-paced environment with keen attention to detail
- Highly organized, self-motivated, and capable of working independently while following through on responsibilities
- Excellent written and verbal communication skills, with the ability to collaborate effectively across all organizational levels
