Senior Manager, Quality Systems
Kyverna Therapeutics
full-time
Posted on:
Location Type: Hybrid
Location: Emeryville • California • United States
Visit company websiteExplore more
Salary
💰 $160,000 - $180,000 per year
Job Level
About the role
- Provide quality expertise supporting the development and commercialization of Kyverna’s products in compliance with relevant US, EU, and ICH requirements.
- Actively manage, develop, implement, and report on Quality Systems, including Deviations, Investigations, CAPAs, Change Controls, Quality Metrics, and electronic Quality Management Systems (eQMS).
- Serve as a subject matter expert and strategic partner across Technical Operations, Clinical, Regulatory Affairs, and other cross-functional teams.
- Oversee execution, scalability, and continuous improvement of Kyverna’s Quality Management System as the organization grows and matures.
Requirements
- Bachelor’s degree in Computer Science, Life Sciences, or a related field, or equivalent relevant experience.
- Minimum of 8 years of experience in the pharmaceutical or biotechnology industry, including 6+ years in Quality Systems / Quality Assurance.
- Demonstrated experience implementing, administering, and improving an eQMS, including system configuration, validation support, and lifecycle management.
- Strong working knowledge of quality system data management, reporting, and data integrity principles.
- First-hand experience managing and reviewing deviations, investigations, CAPAs, and change controls in a regulated environment.
- Experience using validated computerized systems to manage regulated quality records.
- Proven ability to develop and implement enhancements to electronic Quality Systems to improve usability, compliance, and reporting.
- Strong proficiency with Microsoft Office Suite and related business applications.
- Ability to manage multiple priorities in a fast-paced, evolving environment with strong attention to detail.
- Highly organized, self-motivated, and capable of working independently while effectively collaborating cross-functionally.
- Excellent written and verbal communication skills, with the ability to influence and interact effectively at all levels of the organization.
Benefits
- This position is also eligible for bonus
- Benefits
- Participation in Company’s stock plan
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Quality SystemsDeviationsInvestigationsCAPAsChange ControlsQuality Metricselectronic Quality Management Systems (eQMS)data managementdata integrity principlessystem configuration
Soft Skills
attention to detailorganizational skillsself-motivatedcollaborationcommunication skillsinfluencing skillsability to manage multiple prioritiesindependencestrategic partnershipcontinuous improvement