Senior Clinical Quality Assurance Manager - Remote

Overview

The Senior Clinical Quality Assurance Manager at WEP Clinical oversees the maintenance and compliance of the Quality Management System, ensuring adherence to quality principles and Good Clinical Practice (GCP) regulatory requirements.

In Short

• Oversee quality assurance framework for clinical services.
• Ensure compliance with GCP, FDA, EMA, and internal standards.
• Manage quality records and processes including deviations and CAPAs.
• Conduct risk assessments to identify potential quality risks.
• Perform audits and inspections to assess compliance.
• Host client and regulatory inspections, coordinating audits.
• Monitor and deliver training on quality assurance principles.
• Oversee external vendors for compliance with quality standards.
• Identify and implement process improvements for clinical services.
• Serve as the key quality contact for projects.

Requirements

• Bachelor’s degree or higher in pharmaceutical sciences, life sciences, or nursing.
• 7+ years of experience in clinical research focusing on quality assurance.
• In-depth knowledge of clinical trial methodologies and regulatory requirements.
• Experience with decentralized clinical trials and remote patient monitoring is a plus.
• Expertise in developing quality assurance systems and change management.

Benefits

• Join a mission-driven organization dedicated to advancing clinical research.
• Be part of a dynamic team that encourages innovation and collaboration.
• Opportunity to make a real difference in clients' and patients' lives.