Director, Clinical Quality

Revolution Medicines

Redwood City, United States
$201,000—$251,000 usd py
On-site
Gcp quality systems procedures
Risk-based gcp audit program
Manage external gcp auditors
Revolution Medicines is seeking a Director of Clinical Quality to oversee quality assurance for clinical trials, specifically focused on RAS-addicted cancers. The role requires extensive experience in clinical quality assurance and regulatory compliance, with a focus on late-stage clinical studies

Job Summary

  • Provide quality and compliance oversight for RevMed-sponsored clinical trials with respect to SOPs, regulatory requirements, and industry standards.
  • Manage external GCP auditors, support regulatory inspections, and ensure CAPA plans adequately address findings.
  • Manage a team of clinical QA professionals and contractors, mentoring QA staff and building positive professional relationships.

Matching Summary

Match Score: 85

Revolution Medicines is seeking a Director of Clinical Quality to oversee quality assurance for clinical trials, specifically focused on RAS-addicted cancers. The role requires extensive experience in clinical quality assurance and regulatory compliance, with a focus on late-stage clinical studies.

Salary

$201,000—$251,000 USD

Skills & Requirements

Must-have

  • GCP Quality Systems procedures
  • risk-based GCP audit program
  • manage external GCP auditors
  • support regulatory inspections
  • oversee study documentation TMF
  • quality reviews of Clinical Study Documents
  • manage clinical QA professionals

Nice-to-have

  • support learning and open communication
  • build positive professional relationships

Key Requirements

  • Bachelor of Science in scientific or technical discipline
  • Minimum 15 years pharmaceutical clinical quality assurance experience
  • Extensive knowledge of ICH E6, FDA, EMA, HC, PMDA
  • Experience with phase-appropriate quality systems
  • Experience in regulatory inspections
  • Professional and respectful communication skills
  • Ability to work on multiple projects

Work Rights

Not specified

Tailored Resume

Cover Letter