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Quality Systems Manager

1 month ago

Emeryville, California, United States Kyverna Therapeutics Full time
Quality Systems Manager

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases.

The company's therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells at the origin of autoimmune and inflammatory diseases.

We are seeking a Quality Systems Manager to provide quality expertise to support the development and commercialization of our products in compliance with relevant US, EU, and ICH requirements.

The successful candidate will be responsible for actively managing and reporting on quality systems activities related to Deviations, Investigations, CAPAs, Change Controls, and Quality Metrics.

This role will be highly collaborative across all groups in Technical Operations with the overall responsibility to support the execution, development, and continuous improvement of the QMS programs at Kyverna as we grow and mature organizationally.

Key Responsibilities:

  • Manage processes and SOPs for Deviations, Investigations, CAPA, Change Control, and Quality Metrics.
  • Provide hands-on expertise in the day-to-day management of QMS records in our eDMS.
  • Responsible for monitoring overall quality system effectiveness and continuous improvements.
  • Create and deliver training associated with QMS programs and eQMS functionality.
  • Compile, evaluate, and prepare quality metrics for routine KPI reports.
  • Perform trending of KPIs to assist in identifying potential risks and supporting continuous improvement.
  • Adhere to all cGMPs, compliance/regulatory mandates, and quality requirements.
  • Build and maintain relationships with other departments and establish a culture of engagement and transparency with Quality.
  • Perform other duties as assigned.

Requirements:

  • Bachelor's degree in Computer Science, Life Science, or related field or applicable experience.
  • A minimum of 8 years of relevant experience in the pharmaceutical/biotechnology industry with at least 6+ years in Quality Systems/Quality Assurance.
  • First-hand experience in managing and reviewing quality system records (e.g., deviation, CAPA, investigation, change control).
  • Experience in the use of validated computer systems for management of regulated quality management system records.
  • Experience with Dot Compliance, preferred.
  • Experience developing improvements to electronic Quality Systems.
  • Strong software proficiency with Microsoft Suite and other desktop applications.
  • Ability to manage multiple projects in a dynamic environment with attention to detail.
  • A well-organized, self-motivated, and independent work style with the ability to initiate and follow through on expected duties.
  • Excellent written and verbal communication and collaboration skills with the ability to interact with all levels throughout the organization.