Senior Manager, Clinical Quality Assurance

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🏄 California – Remote

🏄 California – Remote

💵 $165k - $180k / year

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

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Arcus Biosciences

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

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. Located in the San Francisco bay area, Arcus specializes in protein therapeutics, immuno-oncology, medicinal chemistry, and large molecule drug discovery. The company is focused on the discovery, development, and commercialization of novel combination therapies to treat cancer in areas of high unmet need, operating in a dynamic and team-driven environment.

📋 Description

• Support clinical study teams as a core team member through study management meetings, study document review, and GCP-related QA consultation • Identify and escalate serious non-compliance issues, including assessment of serious breaches • Maintain expertise in global GCP regulations and internal policies affecting clinical study conduct • Serve as Clinical QA point of contact for assigned clinical functional areas and projects • Support management of study-specific deviations, events, and CAPAs in the GCP/PV space • Collaborate with CRO quality counterparts, including participation in QA-QA meetings • Participate in internal and external GCP audits and manage assigned audit lifecycle activities, including scheduling, planning, agendas, execution, reports, response evaluation, CAPAs, and closure • Maintain audit execution results in Arcus’s electronic quality management system, preferably Veeva Quality Vault, and report compliance trends • Present audit findings and related information to departmental personnel • Work with auditees to complete corrective and preventive actions • Support QA activities during partner audits and regulatory inspections • Participate in inspection readiness and pre-approval inspection preparation with study teams, functional areas, partners, and CROs • Support strategic quality and compliance process improvement initiatives • Lead audits of investigator sites, internal functional/process areas, and clinical vendors (GCP, GCLP, GPvP) • Support Investigator Site Audits

🎯 Requirements

• Bachelor of Science/Bachelor of Art in a relevant discipline required; Biological or Life Sciences preferred • 6+ years in pharmaceutical drug development in Clinical Quality Assurance and/or GCP-related discipline • Quality Auditor/Manager certification preferred • Excellent working knowledge and interpretation of ICH Guidelines and domestic and international GCP regulations • Experience leading audits of GCP/GCLP/GPvP vendors, investigator sites, and internal clinical functional areas • Experience managing inspection readiness activities and supporting FDA, EMA, and other health authority inspections • Ability to build and maintain positive relationships across the organization • Self-motivated; able to take initiative, ownership, and manage multiple responsibilities under tight timelines • Excellent customer-service orientation and high degree of professionalism • Ability to work with limited direction • Excellent oral and written communication skills • Ability to work in a standard office setting and use standard office equipment, including a computer • Ability to lift, carry, push, and pull materials and objects weighing up to 25 pounds

🏖️ Benefits

• Stock programs • Performance-based bonus • Comprehensive benefits package