Associate Director, GCP Quality Oversight

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH.

Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).

Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To support our continued growth, we are strengthening our workforce strategy to ensure we have the right talent, at the right time, in the right way.

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, and may lead/mentor GCP quality staff.

Key Responsibilities                         

Execution of Oversight Strategy & Key Clinical Vendor Quality Governance

• Implement GCP oversight standards and governance cadence (key vendor portfolio risk reviews, issue triage/escalation, readiness checkpoints) across global clinical programs.
• Manage quality to quality partnership with key clinical vendors, ensuring quality agreements/expectations, performance metrics, and corrective actions drive sustained improvement.
• Monitor emerging regulations, guidance documents, and industry best practices and assess impact to the overall quality management system.
• Produce deliverables such as program/study level Quality Risk Management Plans

Portfolio & Audit Management

• Drive systemic issue identification and cross-study actions based on trends (findings, deviations, CAPA performance, audit outcomes).
• Attend study team meetings to provide quality guidance and proactive risk assessment.
• Review key clinical and regulatory documents such as IBs, Protocols, Amendments, Informed Consent Forms, TMF Plans, submission documents.
• Develop and execute risk-based audit strategies and contribute to the annual GCP audit plan.
• Manage external audit partners and consultants from planning through closure activities.
• May lead and will oversee audits of clinical trial vendors, investigator sites, Documents/TMFs and internal processes.
• Provide support in and lead audit report reviews, track and follow-up on Findings and Observations
• Track and/or follow-up on Internal, Vendor/Site CAPAs, Quality Event investigations, deviations, potential serious breaches and misconduct investigations through to closure
• Analyze quality metrics and identify opportunities for process improvement and compliance enhancement.
• Act as a trusted quality advisor to R&D leadership and study teams to provide guidance to cross-functional stakeholders.
• Mentor and develop Quality team members.
• Support departmental strategic planning and resource prioritization activities.
• Produce deliverables such as Program level audit planning, quality management review metrics

Inspection Readiness & Quality Issue Escalation/Reporting

• Lead inspection readiness planning and execution for assigned or across programs, coordinating mock inspections, evidence readiness, and response governance as needed.
• Lead investigations and CAPA effectiveness across the portfolio.
• Produce deliverables such as inspection readiness activities or plans and audit/CAPA effectiveness summaries for management review.

Required Qualifications

• 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.

Preferred Qualifications

• BS+ in Life Sciences or related di