Lead, Clinical Quality Assurance - Remote

Arcus Biosciences, Inc.; United States; Remote; USD 130,000 - 145,000; Full time

Benefits offered by this job

Stock options

Performance bonus

Comprehensive benefits package

Job summary

Arcus Biosciences, Inc. is seeking a Manager, Clinical Quality Assurance to support QA activities across clinical development and study teams. You will oversee quality plans, audits, and vendor oversight, ensuring compliance with ICH-GCP and Arcus SOPs.

You’ll partner with clinical functions, lead training, and monitor QA metrics while coordinating with CROs and internal teams in a dynamic biopharma setting.

Qualifications

• Bachelor’s degree in scientific, health sciences or quality-related field.
• 3+ years in pharmaceutical drug development GCP and/or Clinical QA.
• Trained in international GCP regulations (FDA/EMA/ICH).
• Experience with quality and GCP compliance issues.
• Quality certification and clinical supply QA management experience desirable.
• Strong cross-functional stakeholder management experience.
• Solid knowledge of drug development processes (Ph I–IV).
• Flexible with a risk-based approach to quality and ownership across functions.
• Ability to influence, negotiate, and build relationships with stakeholders.
• Strong project management, leadership, and organization skills.

Responsibilities

• Collaborate with stakeholders to track QA activities and inspect readiness.
• Manage electronic quality management systems for ongoing QA work.
• Support external GCP audits of CROs and suppliers.
• Support Investigator site audits for applicable trials.
• Support internal process audits for clinical and pharmacovigilance.
• Identify and escalate significant compliance issues; assist investigations.
• Join study teams to ensure ICH-GCP compliance and SOP adherence.
• Liaise with CRO Quality Team for ongoing issue review.
• Assist in developing GCP training materials for clinical functions.
• Collect audit/inspection data and present trends for QA monitoring.
• Ensure timely completion of tasks with status updates.
• Expand expertise in international GCP regulations and Arcus policies.
• Coordinate training requirements with training functions as needed.
• Provide support during internal audits and regulatory inspections.
• Contribute to Inspection Readiness program improvements.
• Participate in quality and compliance initiatives.

Skills

GCP compliance

Cross-functional collaboration

Regulatory knowledge

Documentation & reporting

Project management

Communication skills

Risk assessment

Vendor management

Audit support

Quality systems

Education

Bachelor’s degree in scientific/health sciences or quality-related field

Tools

MS Word

Excel

Project

Visio

PowerPoint

Clinical databases

Quality databases

Job description

Arcus Biosciences, Inc. is seeking a Manager, Clinical Quality Assurance to support QA activities across clinical development and study teams. You will oversee quality plans, audits, and vendor oversight, ensuring compliance with ICH-GCP and Arcus SOPs.

You’ll partner with clinical functions, lead training, and monitor QA metrics while coordinating with CROs and internal teams in a dynamic biopharma setting.