Jobs and Careers

Director of Quality Compliance

UKRemotefull_timeVerifiedPosted 11 Sept 2025

💰 $235,000/yr($200,000/yr – $235,000/yr)

About the role

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
Biopharma experience required to be considered for this role. No exceptions.
Kyverna is seeking an experienced Director of Quality Compliance and Risk Management to lead and optimize our GxP quality systems and risk management framework. In this leadership role, you will establish scalable, risk-based quality infrastructure to ensure operational excellence, compliance, and inspection readiness across Kyverna’s clinical and operational activities. The role offers the opportunity to build and mentor a quality team, support supplier oversight, and collaborate across functions to ensure consistent, high-quality performance aligned with global regulatory standards. If you're passionate about transforming patient care through innovative therapies, join us and help advance life-changing treatments for autoimmune diseases. Title: Director of Quality Compliance Location: Emeryville, CA (Hybrid twice a week) OR Remote west coast hours Travel: up to 20%Reports To: VP GxP Quality Head

Responsibilities

Supplier Qualification & Vendor Management:
Develop and implement a supplier qualification strategy to assess and monitor external partners, contract manufacturing organizations (CMOs), and contract service providers (CSPs).
Create a risk-based audit and supplier assessment strategy to support clinical program timelines and operational goals.
Lead supplier qualification audits and manage internal and external auditors to ensure compliance with GxP and regulatory requirements.
Collaborate with procurement, manufacturing, and technical teams to evaluate supplier performance and support vendor risk management processes.
Establish and maintain supplier quality agreements, defining expectations for compliance and quality standards.
Independently manage domestic and international audits and lead efforts for continuous improvement of quality systems.

Compliance Risk Management & Quality Assurance:
Identify, assess, and manage compliance risks across internal operations and external partnerships.
Design and execute a risk-based quality management system (QMS) aligned with regulatory requirements and industry best practices.
Oversee the development and implementation of corrective and preventive actions (CAPA) to address quality issues and mitigate risks.
Ensure ongoing monitoring and continuous improvement of quality compliance processes and systems.

Inspection Readiness & Audit Management:
Lead the organization’s inspection readiness program to prepare for FDA, EMA, and other health authority inspections.
Conduct mock audits, inspection training, and readiness assessments to support teams across clinical, manufacturing, and technical operations.
Serve as the primary point of contact during regulatory inspections and ensure rapid resolution of any inspection findings.
Manage internal audits to ensure compliance with GxP and regulatory expectations.

Cross-Functional Collaboration & Leadership:
Collaborate closely with manufacturing, regulatory affairs, clinical operations, and external partners to align quality objectives with operational goals.
Provide guidance on GxP requirements and regulatory changes, ensuring they are integrated into business operations.
Build, lead, and mentor a high-performing quality assurance team, fostering a culture of excellence and continuous improvement.

Operational Excellence & Compliance
Collaborate with cross-functional teams (Manufacturing, Clinical Operations, Regulatory Affairs) to identify risks and implement corrective and preventive actions (CAPAs).
Define and maintain policies, procedures, and processes aligned with best industry practices and regulatory requirements.
Lead investigations into critical quality issues and product complaints, driving root cause analysis and CAPA implementation.
Monitor evolving regulatory landscapes (FDA, EMA, ICH) to ensure company processes remain compliant with global standards.
Promote a culture of continuous improvement and sustainable compliance throughout the