Similar Jobs
See allManager, Quality Assurance
Rezolute
US
GMP
GxP
FDA
Global GxP Regulatory Intelligence Compendia Manager (Contract)
Vertex Pharmaceuticals
US
GMP
Analytical
Project Management
QMS Training Manager
Celcuity
US
GxP
Veeva
MS Office
Associate Director, Drug Product Development & Manufacturing
Mineralys Therapeutics
US
GMP
FDA
ICH
Clinical Research Associate
Kyverna Therapeutics
US
Clinical Operations
Site Management
ICH-GCP
Responsibilities:
- Lead and execute internal audits across GMP, GCP, and GPV systems.
- Conduct GxP audits in accordance with applicable regulatory requirements.
- Perform risk assessments and drive continuous improvement initiatives.
Qualifications:
- ASQ Certified Quality Auditor (CQA) or equivalent certification required.
- Minimum of 10+ years of experience in the pharmaceutical or biotechnology industry.
- Strong working knowledge of GMP, GCP, GPV, and GLP regulations.
Preferred Qualifications:
- Experience in quality management within a GxP-regulated environment.
- Experience supporting cell and/or gene therapy products.
- Strong strategic thinking and project management skills.
Kyverna Therapeutics
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, we are committed to transforming the future of treatment for autoimmune disease.