Associate Director, Clinical Quality Assurance (Study Compliance) - Remote

Overview

This position supports the Clinical Quality Assurance function by providing GCP compliance oversight and support to Arcus Clinical Development therapeutic areas. The key activity of the role is providing expertise and guidance regarding applicable regulatory, Good Clinical Practice, and Arcus Standard Operating Procedure requirements for the conduct of clinical studies.

In Short

• Support clinical study teams as a core team member for assigned studies.
• Identify and escalate serious non-compliance issues.
• Maintain expertise in global GCP regulations.
• Act as Clinical QA point of contact for specific clinical functional areas.
• Support management of study-specific deviations/events/CAPAs.
• Collaborate with CRO quality counterparts.
• Participate in internal and external GCP audits.
• Maintain audit execution results in electronic quality management system.
• Present audit findings to departmental personnel.
• Support Quality Assurance activities during partner audits.

Requirements

• Bachelor of Science/Art in a relevant discipline required.
• Minimum of 8+ years in pharmaceutical drug development.
• Excellent knowledge of ICH Guidelines and GCP regulations.
• Ability to build and maintain positive relationships.
• Self-motivated with the ability to manage multiple responsibilities.
• Excellent customer-service orientation and professionalism.
• Excellent oral and written communication skills.
• Some experience auditing clinical investigator sites preferred.
• Ability to travel up to approximately 15% domestic and international.

Benefits

• Competitive market-based salary.
• Opportunity to participate in stock programs.
• Performance-based bonus.
• Comprehensive benefits package.