Associate Director, Clinical Quality Assurance (Audits & Inspections) - Remote

Overview

This position supports the Clinical Quality Assurance function by providing GCP compliance oversight and support to Arcus Clinical Development therapeutic areas.

In Short

• Provide expertise and guidance on regulatory and GCP requirements.
• Manage health authority inspections and audits.
• Lead audits of investigator sites and clinical vendors.
• Participate in the development of GCP-related Policies and SOPs.
• Support inspection readiness activities.
• Mentor junior members of the CQA organization.
• Identify and escalate compliance issues.
• Collaborate with clinical functional areas.
• Manage annual audit programs.
• Contribute to quality and compliance initiatives.

Requirements

• 8 to 10 years of experience in a GCP related discipline.
• Expert knowledge of global GCP regulations.
• Experience leading audits of clinical vendors and sites.
• Strong analytical and strategic assessment skills.
• Ability to influence and negotiate cross-functionally.
• Bachelor’s degree in a medical or health sciences related field.
• Strong computer literacy in MS Office and Veeva Vault.
• Ability to travel up to 30% domestically and internationally.

Benefits

• Competitive market-based salary.
• Participation in stock programs.
• Performance-based bonus.
• Comprehensive benefits package.