Nkarta, Inc.

QA Engineer

• Proactively provide GCP QA support for clinical development activities to protect patient safety & wellbeing, maintain data integrity, and support operational excellence
• Independently conduct Clinical Investigator Site Audits, GCP Document Audits (Clinical Study Reports and Trial Master Files), internal Process Audits and support Vendor/System audits
• Author and manage Audit Plans and Audit reports
• Facilitate ongoing quality improvement through communication of audit results, CAPAs and GCP guidance and consultation to clinical teams
• Manage health authority inspection preparation activities and provide leadership and oversight during inspections
• Review and provide input to clinical documentation (e.g. protocols, study reports, IBs, ICFs, etc.)
• Compile and analyze audit metrics to communicate trends to business groups
• Maintains a high level of expertise in GCP drug development regulations, ICH guidelines and internal policies and procedures that may impact drug development.
• Conduct GCP training sessions for business groups
• Build out the GCP function to support pivotal readiness
• Manage direct reports (if applicable)

Senior Director, Head of GCP Quality Assurance