Madrigal is focused on developing therapeutics to improve the lives of patients with metabolic and fatty liver diseases.
Senior Manager, GCP Quality Assurance
Location
Pennsylvania
Posted
30 days ago
Salary
$147K - $180K / year
Seniority
Senior
Job Description
Senior Manager, GCP Quality Assurance
Madrigal Pharmaceuticals
• Responsible for GCP/Clinical Quality Assurance activities • Ensure quality and compliance of Madrigal-sponsored clinical trials • Develop, implement, and/or maintain clinical quality systems and processes • Align organization to ICH in implementing a quality culture • Engage partnership with external clinical trial vendors • Conduct or manage internal/external audits • Lead reviews, manage documentation, and track Observations/Findings • Review key clinical program or study documents
Job Requirements
- Minimum 7 years of experience in clinical quality assurance within the biopharmaceutical or CRO industry
- Minimum 3-5 years of experience in a clinical operations role at a CRO or Sponsor
- Experience in inspection preparation and/or supporting health authority/regulatory agency inspections
- Demonstrated GCP knowledge
- BS in a scientific or other relevant discipline with equivalent work experience
Benefits
- Flexible paid time off
- Medical insurance
- Dental insurance
- Vision insurance
- Life/disability insurance
- 401(k) offerings (traditional, Roth, employer match)
- Supplemental life insurance
- Legal services
- Mental health benefits through Employee Assistance Program
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