1d ago

Associate Director, Clinical Quality Assurance

Redwood City, California, United States

$186k-$233k / year

full-timelead Hybridbiotech

๐Ÿ›  Tech Stack

๐Ÿ’ผ About This Role

You'll provide leadership and compliance support for RevMed's clinical trials within Quality Assurance. You'll enable risk-based quality management and a culture of quality across clinical teams. This role offers the chance to support GCP audits and inspections and contribute to inspection readiness for a late-stage oncology company.

๐ŸŽฏ What You'll Do

  • Provide GCP compliance support to clinical functions.
  • Participate in clinical study execution teams for risk-based quality management.
  • Perform quality review of clinical trial documents.
  • Support planning and conduct of GCP audits and inspections.

๐Ÿ“‹ Requirements

  • Bachelor's degree in scientific or technical discipline.
  • 10+ years of experience in GCP Quality in pharma/biotech.
  • 8 years in audit, inspection readiness, or CAPA management.
  • Extensive knowledge of ICH GCP and FDA regulations.

โœจ Nice to Have

  • Good knowledge of Computer System Validation.
  • Experience with deviation/CAPA management systems.
  • Audit management experience.

๐ŸŽ Benefits & Perks

  • ๐Ÿ’ฐ Competitive base pay ($186k-$233k).
  • ๐Ÿ“ˆ Robust equity awards.
  • ๐Ÿฅ Strong benefits package.
  • ๐Ÿ“š Significant learning and development opportunities.
  • ๐Ÿข Hybrid work model.

๐Ÿ“จ Hiring Process

Estimated timeline: 2-4 weeks ยท AI estimate

  1. 1Recruiter Screenยท 30 min
  2. 2Hiring Manager Interviewยท 60 min
  3. 3Technical Interviewยท 60 min
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