Remote GCP QA Senior Manager

Madrigalpharma; Pennsylvania; Hybride; USD 147 000 - 180 000; Plein temps

Avantages offerts par ce poste

Equity

401(k) plan

Comprehensive benefits

Résumé du poste

Madrigal is seeking a Senior Manager, GCP Quality Assurance to oversee GCP compliance for Madrigal-sponsored trials. The role emphasizes audit leadership, vendor oversight, and CAPA management, ensuring data integrity and patient safety throughout development programs.

The ideal candidate has deep GCP knowledge, extensive QA auditing experience, and strong cross-functional collaboration across R&D, regulatory, and operations.

Qualifications

• Minimum 7 years in clinical quality assurance.
• Experience auditing clinical trial vendors/sites/TMFs.
• 3-5 years in a clinical operations role at a CRO or Sponsor.
• GCP knowledge; GVP/GLP knowledge a plus.

Responsabilités

• Develop and maintain quality systems to ensure ICH GCP compliance.
• Lead audits of vendors, sites, and TMFs.
• Manage CAPAs and quality events through to closure.
• Support inspections and readiness activities with global regulators.
• Collaborate with cross-functional teams across R&D functions.

Connaissances

GCP knowledge

Auditing

Regulatory compliance

Cross-functional collab

Communication

Formation

BS in scientific discipline

Outils

Veeva eQMS

Description du poste

Madrigal is seeking a Senior Manager, GCP Quality Assurance to oversee GCP compliance for Madrigal-sponsored trials. The role emphasizes audit leadership, vendor oversight, and CAPA management, ensuring data integrity and patient safety throughout development programs.

The ideal candidate has deep GCP knowledge, extensive QA auditing experience, and strong cross-functional collaboration across R&D, regulatory, and operations.