Associate Director, GCP Quality Oversight

Madrigal Pharmaceuticals

Lead GCP quality oversight in global clinical programs for Madrigal's liver therapeutics. Ensure compliance and data integrity while mentoring GCP quality staff.

Posted 7/2/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $165,000 - $201,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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

Comp & perks

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Clinical Quality AssuranceGCP Quality OversightRisk-Based OversightIssue ManagementQuality Metrics FrameworksProcess AuditsDocument/TMF AuditsGlobal Health Authority InspectionsData IntegrityMeasurable Recurrence Reduction

Soft Skills

LeadershipMentoringCommunicationCollaborationReporting