Senior Manager, GCP Quality Assurance
About this role
About the Role
The Senior Manager, GCP Quality Assurance will lead and ensure quality and compliance for Madrigal-sponsored clinical trials in accordance with ICH GCP, FDA/EMA guidelines, Madrigal SOPs, and industry best practices. You will report to the Senior Director, GCP Quality and partner with cross-functional teams to promote patient safety and data integrity.
What You'll Do
- Develop, implement, and maintain clinical quality systems to ensure compliance with ICH GCP, FDA, EMA, and global requirements.
- Align the organization to ICH GCP and cultivate a quality culture from trial start through completion to promote patient safety and data integrity.
- Apply risk-based, cross-functional oversight; attend internal/external study team calls; escalate as needed.
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