Manager/Senior Manager, Quality Systems

Reposted 21 Days Ago
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Emeryville, CA
Hybrid
Senior level
Biotech
The Role
The Manager/Senior Manager, Quality Systems oversees quality system activities, ensuring compliance with regulations, managing documentation, and fostering collaboration across teams to improve QMS execution.
Summary Generated by Built In

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The Kyverna therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells at the origin of autoimmune and inflammatory diseases. Be at the forefront of cell therapy innovation by joining scientists, industry veterans and healthcare visionaries and help transform how autoimmune diseases are treated


Location: Emeryville (Hybrid) Two days onsite per week


We are seeking a Manager/Senior Manager, Quality Systems to provide quality expertise to support the development and commercialization of Kyverna’s products in compliance with relevant US, EU and ICH requirements. The Manager, Quality Systems will be responsible for actively managing and reporting on quality systems activities related to Deviations, Investigations, CAPAs, Change Controls, and Quality Metrics.

In addition to serving as a subject matter expert in these areas, 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.



Top Skills

Dot Compliance
Edms
Microsoft Suite
Quality Management Systems
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The Company
HQ: Emeryville, CA
55 Employees
On-site Workplace
Year Founded: 2018

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.

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