Associate Director, CQA

Job not on LinkedIn

2 days ago

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

💵 $185k - $200k / year

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

🦅 H1B Visa Sponsor

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Arcus Biosciences

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Arcus Biosciences is a rapidly growing, clinical-stage, global biopharmaceutical company developing differentiated molecules and combination medicines that may have the potential to help people with cancer live longer.

501 - 1000 employees

📋 Description

• 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