4h ago

Associate Director/Director, GCP Quality Assurance

South San Francisco, California, United States
full-timedirectorbiotechnology

Description

You will provide hands-on quality oversight and GCP guidance to clinical study teams and vendors, ensuring compliance with regulatory requirements and data integrity. You'll lead audit activities, manage CAPAs, and drive a culture of quality as the company advances its GPCR-targeted pipeline.

Requirements

  • Bachelor's degree in life sciences or related field; advanced degree preferred
  • 10+ years of Quality Assurance experience in biopharmaceutical industry with progressive Clinical QA responsibility
  • Minimum 8+ years of hands-on GCP audit experience (investigator sites, CROs, clinical vendors)
  • Strong working knowledge of ICH GCP and applicable global regulatory requirements
  • Ability to operate independently and build processes in a lean environment

Responsibilities

  • Provide hands-on quality oversight and GCP guidance to clinical study teams and CROs/vendors
  • Review and assess key clinical documents (protocols, monitoring plans, TMF plans, data management plans)
  • Lead and execute GCP audit activities (CROs, vendors, investigator sites), including CAPA evaluation and follow-up
  • Provide day-to-day quality guidance for issue management, deviations, and inspection readiness
  • Contribute to development and tracking of GCP quality metrics for continuous improvement
0 views 0 saves 0 applications