Director of Quality Compliance - Remote

Overview

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.

In Short

• Lead and optimize GxP quality systems and risk management framework.
• Establish scalable, risk-based quality infrastructure.
• Build and mentor a quality team.
• Support supplier oversight and vendor management.
• Ensure compliance with global regulatory standards.
• Manage internal and external audits.
• Design and execute a risk-based quality management system.
• Prepare the organization for regulatory inspections.
• Collaborate with cross-functional teams.
• Promote a culture of continuous improvement.

Requirements

• Advanced degree in Life Sciences, Pharmacy, or related field.
• 10+ years in GxP compliance and quality management.
• Experience with cell therapy or genetically modified products preferred.
• In-depth knowledge of FDA, EMA regulations, and ICH guidelines.
• Track record in managing quality systems across product lifecycles.
• Strong leadership in matrix environments.
• Expertise in problem-solving and strategic thinking.
• Exceptional communication skills.
• Self-starter who thrives in collaborative environments.

Benefits

• Opportunity to transform patient care through innovative therapies.
• Collaboration with a team of experts.
• Leadership role in a growing company.
• Mentorship and professional development opportunities.
• Work in a hybrid model with remote options.