Senior Manager, GCP Quality Assurance

Madrigal Pharmaceuticals seeks a Senior Manager for GCP Quality Assurance to oversee clinical trial compliance, quality systems, and regulatory adherence across sponsored studies. The role ensures alignment with ICH GCP guidelines, FDA/EMA requirements, and company standards while managing vendor relationships, audits, and quality investigations.

Responsibilities

• Develop, implement, and maintain clinical quality systems ensuring ICH GCP and global regulatory compliance
• Conduct and manage internal and external audits of vendors, sites, and TMFs; prepare audit reports
• Lead quality event investigations, manage CAPAs, deviations, and quality metrics through closure
• Review clinical program documents including protocols, informed consents, and investigator brochures
• Coordinate inspection readiness activities and support regulatory agency inspections

Requirements

• Minimum 7 years clinical quality assurance experience in biopharmaceutical or CRO industry
• 3-5 years clinical operations experience at CRO or sponsor level with cross-functional study management
• Demonstrated GCP knowledge; GVP/GLP certifications preferred
• Experience auditing clinical trial vendors, sites, TMFs, or internal R&D processes
• BS in scientific or relevant discipline with equivalent work experience
• Proficiency with eQMS systems such as Veeva
• Inspection preparation and health authority inspection support experience preferred