Director of Quality Compliance
Remote
Quality /
Full Time /
Remote
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
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
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 organization.
Qualifications
- Advanced degree in Life Sciences, Pharmacy, or related field.
- 10+ years in GxP compliance and quality management within the biotechnology or pharmaceutical industry.
- Experience with autologous/allogeneic cell therapy or genetically modified products is strongly preferred.
- In-depth knowledge of FDA, EMA regulations, and ICH guidelines, particularly those related to cell-based therapies.
- Track record of managing quality systems across product lifecycles, including preparation for health authority inspections.
- Strong leadership in matrix environments with experience influencing cross-functional teams.
- Expertise in problem-solving, strategic thinking, and risk management.
- Exceptional verbal and written communication, with the ability to present complex topics to stakeholders at all levels.
- Self-starter who thrives in collaborative environments, with the ability to build strong relationships based on trust and transparency.
The salary range for this position in Northern California is from $200,000 to $235,000 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
