Associate Director, CQA
Arcus BiosciencesHayward, California, United States
Posted October 23, 2025
185000 - 200000 USD year
Full Time
About the Company
Arcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.
Job Description
The Associate Director, Clinical Quality Assurance is responsible for working with study management teams to facilitate internal and external adherence to Quality and Regulatory Compliance by ensuring conformance to domestic and international quality regulations and GCP guidelines.
Requirements
- Bachelor of Science/ Bachelor of Art in a relevant discipline required (Biological or Life Sciences preferred)
- 8+ years in pharmaceutical drug development in Clinical Quality Assurance and/or GCP-related discipline
- Previous experience working with clinical study teams required
- Excellent working knowledge and interpretation of ICH Guidelines and GCP domestic and international regulations
- Experience leading audits of GCP/GCLP/GPvP vendors, investigator sites, and internal audits of clinical functional areas
- Experience managing inspection readiness activities and supporting FDA, EMA, and other health authority inspections
- Excellent oral and written communication skills
- Must possess mobility to work in a standard office setting and use standard office equipment
Benefits
- Stock programs
- Performance-based bonus
- Comprehensive benefits package
