Associate Director, CQA
Arcus Biosciences
full-time
Posted on:
Location Type: Remote
Location: Remote • California • 🇺🇸 United States
Visit company websiteSalary
💰 $185,000 - $200,000 per year
Job Level
Senior
Tech Stack
Google Cloud PlatformVault
About the role
- Work with study management teams to facilitate adherence to Quality and Regulatory Compliance
- Ensure conformance to domestic and international quality regulations and GCP guidelines
- Participate in day-to-day QA Compliance operations
- Provide GCP compliance oversight and support to Arcus Clinical Development therapeutic areas
- Provide expertise regarding applicable regulatory, Good Clinical Practice, and Arcus Standard Operating Procedure requirements
- Support the management of study-specific deviations/events/CAPAs in the GCP/PV space
- Collaborate with CRO quality counterparts
- Participate in internal and external GCP audits
- Maintain up to date audit results in Arcus electronic quality management system (Veeva Quality Vault, preferred)
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
- Must have the ability to build and maintain positive relationships with department management, peers, and other colleagues across the organization
- Self-motivated with the ability to take initiative, ownership and manage multiple responsibilities while shifting priorities quickly under tight timelines
- Must have excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction
- Excellent oral and written communication skills.
Benefits
- Opportunity to participate in stock programs
- Performance-based bonus
- Comprehensive benefits package
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
GCP complianceQuality Assuranceaudit managementregulatory compliancedeviation managementCAPA managementinspection readinessICH Guidelinesclinical study oversightVeeva Quality Vault
Soft skills
relationship buildingself-motivationinitiativeownershipmulti-taskingcustomer service orientationprofessionalismcommunication skills