Senior Manager, GCP Quality Assurance
Madrigal Pharmaceuticals · Pennsylvania, PA
QualityRemoteFull-time$147k–$180kCompany career page
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Role summary
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.
What they're looking for
- 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
What you'll be doing
- 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
Privacy & handoff
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