Remote Clinical QA Manager – GCP & Compliance

Arcus Biosciences, Inc.; Hayward (CA); Vor Ort; USD 130.000 - 145.000; Vollzeit

Benefits dieser Stelle

Stock options

Performance-based bonus

Benefits package

Zusammenfassung

Arcus Biosciences, Inc. in Hayward, CA is seeking a Manager, Clinical Quality Assurance to support annual quality plan execution, supervise QA activities across clinical development and study teams, and ensure compliance with ICH-GCP and Arcus SOPs.

You will coordinate audits, manage electronic QMS, collaborate with CROs and suppliers, contribute to training, and help inspector readiness, with a focus on risk-based quality and effective issue resolution.

Qualifikationen

• Bachelor’s degree in scientific, health sciences or quality-related field.
• 3+ years in pharmaceutical drug development GCP/Clinical QA.
• Knowledge of USA FDA, EMA, ICH-GCP guidelines.
• Experience managing quality and GCP compliance issues.
• Cross‑functional stakeholder management and risk-based quality mindset.
• Strong project management, leadership, and communication skills.
• Flexible with a risk-based approach to quality and ownership across functions.
• Ability to influence, negotiate cross-functionally, and build relationships.

Aufgaben

• Collaborate with stakeholders to gather up-to-date QA activity data.
• Manage electronic quality management systems for ongoing QA tasks.
• Support external GCP audits of service providers and CROs.
• Support Investigator site and internal process audits.
• Identify and escalate significant compliance issues; assist investigations.
• Participate in study teams to ensure ICH-GCP adherence and SOP compliance.
• Develop training materials and support GCP training needs.
• Assist in training material development for GCP and SOPs.

Kenntnisse

GCP knowledge

Cross-functional mgmt

Project management

Quality governance

Regulatory awareness

Project leadership

Communication skills

Risk assessment

Ausbildung

Bachelor’s degree in scientific/health sciences

Quality certification

Tools

MS Word

Excel

Project

Visio

PowerPoint

Clinical/Quality databases

Jobbeschreibung

Arcus Biosciences, Inc. in Hayward, CA is seeking a Manager, Clinical Quality Assurance to support annual quality plan execution, supervise QA activities across clinical development and study teams, and ensure compliance with ICH-GCP and Arcus SOPs.

You will coordinate audits, manage electronic QMS, collaborate with CROs and suppliers, contribute to training, and help inspector readiness, with a focus on risk-based quality and effective issue resolution.