Senior Manager, Quality Management System QMS

Kyverna Therapeutics

Senior Manager overseeing Quality Management System for a biopharmaceutical firm developing cell therapies. Ensuring compliance with US, EU, and ICH requirements while leading Quality Systems initiatives.

Posted 7/6/2026full-timeEmeryville • California • 🇺🇸 United StatesSenior💰 $160,000 - $180,000 per yearWebsite

About the role

Key responsibilities & impact

Manage and maintain processes, SOPs, and workflows for Deviations, Investigations, CAPA, Change Control, Quality Metrics, and other core QMS programs.
Provide QA oversight of Information Technology systems supporting GxP processes.
Lead or support the implementation, configuration, validation, and optimization of the electronic Quality Management System (eQMS), ensuring phase-appropriate design and scalability.
Provide hands-on expertise in the day-to-day execution, review, and management of QMS records within the eQMS.
Partner with internal stakeholders to define data governance, system configuration, user roles, and reporting requirements for quality systems.
Ensure data integrity, traceability, and compliance of quality system data in accordance with regulatory expectations (e.g., ALCOA+ principles).
Monitor overall QMS effectiveness, identify gaps or inefficiencies, and drive continuous improvement initiatives.
Recommend updates to quality policies and procedures and implement process improvements aligned with organizational growth and regulatory readiness.
Develop, compile, analyze, and present quality metrics and KPIs for routine quality management review.
Perform trending and data analysis to identify risks, systemic issues, and opportunities for improvement.
Create and deliver training programs related to QMS processes, data integrity, and eQMS functionality.
Support inspection readiness and ensure adherence to cGMPs, regulatory mandates, and internal quality standards.
Build and maintain strong cross-functional relationships and foster a culture of engagement, transparency, and quality ownership.
Perform other duties as assigned.

Requirements

What you’ll need

Bachelor’s degree in Computer Science, Life Sciences, or a related field, or equivalent relevant experience.
Demonstrated experience implementing, administering, and improving an eQMS, including system configuration, validation support, and lifecycle management.
Minimum of 8 years of experience in the pharmaceutical or biotechnology industry, including 6+ years in Quality Systems / Quality Assurance.
Strong working knowledge of quality system data management, reporting, and data integrity principles.
First-hand experience managing and overseeing 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 eQMS 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

Comp & perks

bonus
benefits
participation in Company’s stock plan.

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Quality Management Systems (QMS)Electronic Quality Management Systems (eQMS)Data AnalysisQuality Metrics DevelopmentSystem ConfigurationValidation SupportLifecycle ManagementRegulated Quality Records ManagementProcess ImprovementQuality Assurance

Soft Skills

Excellent Communication SkillsAttention to DetailOrganizational SkillsSelf-MotivatedCross-Functional Collaboration