1d ago
Associate Director, Clinical Quality Assurance
Redwood City, California, United States
$186k-$233k / year
full-timelead Hybridbiotech
๐ Tech Stack
๐ผ 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.
๐ฏ 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.
๐ 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.
โจ Nice to Have
- Good knowledge of Computer System Validation.
- Experience with deviation/CAPA management systems.
- Audit management experience.
๐ Benefits & Perks
- ๐ฐ Competitive base pay ($186k-$233k).
- ๐ Robust equity awards.
- ๐ฅ Strong benefits package.
- ๐ Significant learning and development opportunities.
- ๐ข Hybrid work model.
๐จ Hiring Process
Estimated timeline: 2-4 weeks ยท AI estimate
- 1Recruiter Screenยท 30 min
- 2Hiring Manager Interviewยท 60 min
- 3Technical Interviewยท 60 min
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