Reports To: Sr Director, Quality Assurance Operations
Responsibilities
- Review executed batch records and supporting documentation to ensure accuracy, completeness, and compliance with applicable requirements.
- Support batch disposition and product release activities while maintaining adherence to established timelines.
- Consistently meet production release schedules and quality deliverables.
- Proactively identify, investigate, and escalate quality and compliance issues to Quality Management.
- Provide quality oversight and guidance regarding documentation discrepancies, deviations, and compliance-related matters.
- Maintain and update the vendor change notification tracking system and support the monitoring of key quality and operational performance metrics.
- Partner with cross-functional teams to facilitate the timely assessment, implementation, and closure of vendor change notifications.
- Support quality system processes, including deviations, change controls, CAPAs, and vendor change management activities.
- Ensure compliance with cGMP regulations, ICH guidelines, and company SOPs and quality standards.
- Author, review, revise, and maintain SOPs and other controlled documents to standardize and improve business processes.
- Contribute to continuous improvement initiatives and enhancements to the Quality Management System (QMS).
- Support inspection readiness activities, internal and external audits, and perform additional responsibilities as assigned.
Requirements
- 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
- Ability to work in a matrix environment and build strong relationships by being transparent, reliable, and delivering on commitments.
The national salary range for this position is from $110,000. to $135,000. USD annually. This salary range is an estimate of what we reasonably expect to pay for this position, and the actual salary may vary based on various factors, including without limitation individual education, experience, tenure, skills and abilities, as well as internal equity and alignment with market data. This position is also eligible for bonus, benefits, and participation in Company’s stock plan.
Skills Required
- Bachelor's degree in a life sciences discipline or equivalent experience
- Minimum of 6 years experience in Quality Assurance or related role within biotech, pharmaceutical, or cell/gene therapy industries
- Knowledge and experience with cGMP regulations, ICH guidelines, and Quality Management Systems (QMS)
- Experience with deviations, change controls, CAPAs, vendor change management, and batch record review
- Ability to author, review, revise, and maintain SOPs and controlled documents
- Demonstrated ability to manage multiple priorities in a fast-paced environment with strong attention to detail
- Highly organized, self-motivated, able to work independently and follow through on responsibilities
- Excellent written and verbal communication skills and ability to collaborate across organizational levels
- Ability to work in a matrix environment and build strong cross-functional relationships
What We Do
Kyverna is a cell therapy company engineering and developing a new class of curative living medicines for inflammatory and autoimmune diseases. Using its SmarTcell™ approach which includes synReg-T cell and synNotch CAR-T technology platforms, Kyverna reprograms T cells to target and selectively suppress or eliminate autoreactive immune cells. The company’s goal is to develop therapies that are selective, potent and durable to tame autoimmunity. We build interdisciplinary teams that bring a broad range of experiences and scientific expertise together to develop medicines that will free patients from the siege of autoimmune diseases and bring curiosity for exploring and creating the unknown. Our commitment to our employees is to foster an open, supportive, and inclusive environment where we create opportunities for individuals to learn and grow to their full potential at every level. synNotch is a trademark of Gilead/Kite.
