Madrigal Pharmaceuticals logo
Madrigal Pharmaceuticals

Madrigal is focused on developing therapeutics to improve the lives of patients with metabolic and fatty liver diseases.

Associate Director, GCP Quality Oversight

Location

United States

Posted

3 days ago

Salary

$165K - $201K / year

Seniority

Senior

Bachelor Degree10 yrs expEnglishGoogle Cloud Platform

Job Description

Associate Director, GCP Quality Oversight

Madrigal Pharmaceuticals

• Leads GCP quality oversight for global clinical program(s) to ensure sustained compliance, inspection readiness across internal teams. • Implements standards for risk-based oversight, issue management rigor, translating quality signals into cross-functional actions that protect participants and data integrity. • Oversees quality performance across a portfolio of programs and studies, ensuring measurable recurrence reduction. • Provides executive-ready reporting on quality risks, trends, and readiness. • May lead/mentor GCP quality staff.

Job Requirements

  • Minimum 10 years in clinical quality assurance
  • Minimum 3 years experience in a clinical operations role at a CRO or Sponsor
  • Demonstrated experience conducting and/or overseeing vendor, investigator site, Document/TMF, and process audits.
  • BS+ in Life Sciences or related discipline (Preferred)
  • Experience leading global health authority inspection readiness and responses (e.g., FDA) across sponsor-led and outsourced models (Preferred)
  • Experience implementing/optimizing eQMS workflows and quality metrics frameworks for GCP oversight at scale; Veeva Quality a plus (Preferred)

Benefits

  • flexible paid time off
  • medical insurance
  • dental insurance
  • vision insurance
  • life insurance
  • disability insurance
  • 401(k) offerings (traditional, Roth, and employer match)
  • additional voluntary benefits like supplemental life insurance, legal services
  • mental health benefits through Employee Assistance Program

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