Senior Director of Quality Compliance, GCP Quality, Risk Management
Kyverna Therapeutics
full-time
Posted on:
Location Type: Hybrid
Location: Emeryville • California • 🇺🇸 United States
Visit company websiteSalary
💰 $220,000 - $250,000 per year
Job Level
Senior
Tech Stack
Google Cloud Platform
About the role
- Establish scalable, risk-based quality infrastructure to ensure operational excellence, compliance, and inspection readiness across Kyverna’s clinical and operational activities.
- Provide GCP quality oversight across CAR-T clinical programs, ensuring patient safety, data integrity, and compliance.
- Support supplier oversight and collaborate across functions to ensure consistent, high-quality performance aligned with global regulatory standards.
Requirements
- Degree in Life Sciences, Pharmacy, or related field.
- 15+ years in GxP compliance and quality management within the biotechnology or pharmaceutical industry.
- 8+ years of inspection readiness and management is a must
- Experience with autologous/allogeneic cell therapy or genetically modified products is strongly preferred.
- In-depth knowledge of international GMP and GCP 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.
Benefits
- This position is also eligible for bonus
- benefits
- participation in Company’s stock option plan.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
GxP compliancequality managementinspection readinessautologous cell therapyallogeneic cell therapygenetically modified productsGMP regulationsGCP regulationsICH guidelinesquality systems management
Soft skills
leadershipproblem-solvingstrategic thinkingrisk managementverbal communicationwritten communicationcollaborationrelationship buildinginfluencingself-starter