Associate Director, GCP Quality Oversight
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Job Description
Lead GCP quality oversight in global clinical programs for Madrigal's liver therapeutics. Ensure compliance and data integrity while mentoring GCP quality staff.
Responsibilities:
- 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:
- 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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