Manager, GCP Quality Assurance - Remote

Overview

The Manager, GCP Quality Assurance will be responsible for ensuring quality and compliance of Madrigal-sponsored clinical trials with applicable GCP regulations, ICH GCP guidelines, Madrigal SOPs, and current industry standards and best practices.

In Short

• Responsible for GCP/Clinical Quality Assurance activities.
• Ensure compliance with GCP, FDA, EMA, and global regulatory requirements.
• Develop and maintain clinical quality systems and processes.
• Engage with external vendors and manage quality agreements.
• Conduct or manage internal/external audits and prepare audit reports.
• Support inspection readiness activities.
• Collaborate cross-functionally to promote patient safety and data integrity.
• Stay updated on global regulations and industry best practices.
• Contribute to the annual audit plan and Quality Management Reviews.
• Coordinate services provided by external QA vendors.

Requirements

• 5+ years of experience in clinical quality assurance.
• Strong understanding of GCP, GLP, and drug development processes.
• Ability to develop collaborative relationships.
• Experience in inspection preparation and regulatory agency inspections.
• Knowledge of eQMS systems, such as Veeva.
• BS in a scientific or relevant discipline.
• Excellent communication and organizational skills.
• Occasional travel for team meetings and audits.

Benefits

• Flexible paid time off (PTO).
• Medical, dental, and vision insurance.
• Life and disability insurance.
• Bonus and equity eligibility.
• Comprehensive benefits package.