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Kyverna Therapeutics is a clinical-stage cell therapy company with the mission of engineering a new class of therapies for autoimmune diseases. The Kyverna therapeutic platform combines advanced T cell engineering and synthetic biology technologies to suppress and eliminate the 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.
Kyverna is recruiting a highly motivated Senior Manager of Computer Software Assurance (Computer System Validation) in its Quality organization to help advance its mission to free patients from the siege of autoimmune disease. The ideal candidate will build and lead a Software Quality Assurance (CSA) program focusing on GAMP 5 and Health Authority (Part 11 and Annex 11) compliance for systems wholly managed by Kyverna as well as assessing and communicating risks associated with the the compliance of systems managed by Kyverna contract service providers (CSP) and partners. Adherence to phase appropriate regulatory requirements, enhancing quality compliance, and maintaining the highest standards of quality in CSA for technical, clinical, and regulatory operations is the mission of this role.
The Senior Manager will be responsible for creating and executing a CSA program for Kyverna including quality management elements (SOPs and policies), lifecycle management (validation, change management, risk assessment), and assessing the compliance of computerized systems utilized by Kyverna CSPs in support of clinical operations, manufacturing, and regulatory systems. The role will report to the Head of GxP Quality.
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The salary range for this position is from $140,000 - $155,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted 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 option plan.
Kyverna is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Kyverna is committed to the principle of equal employment opportunity for all employees and does not discriminate on the basis of race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets
Full Time
$134k-168k (estimate)
02/07/2024
05/30/2024
kyvernatx.com
Emeryville, CA
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