Associate Director, Quality Change Management

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 Quality change control governance to ensure changes are risk-assessed, compliant, and implemented with appropriate controls across internal operations and external partners. Establishes predictable, high-quality change execution by aligning stakeholders on impact assessment, readiness criteria, and documentation expectations. Partners with CMC / MSAT, Supply Chain, Operations, and Quality teams to enable tech transfers, validation readiness, and lifecycle changes. Owns change performance metrics (cycle time, aging, quality) and drives continuous improvement of the change process.

Ensures inspection-ready traceability from change initiation through closure.

• Own change control standards, templates, decision rights, and review cadences, ensure consistent risk-based assessments
• Define implementation readiness criteria, verification expectations, and closure quality standards
• Produce deliverables such as change control playbooks, review checklists, and readiness / verification templates

• Coordinate change reviews across Quality / CMC / MSAT / Supply Chain and external partners, align timelines and dependencies
• Escalate high-risk or supply-impacting changes with options, mitigation plans, and decision points
• Produce deliverables such as cross-functional change review packs, decision logs, and dependency trackers

• Own change KPIs and continuous improvement actions, drive predictable throughput without compromising quality
• Ensure inspection-ready change documentation, traceability, and evidence retrieval
• Produce deliverables such as KPI dashboards, aging / backlog reports, and inspection-ready change narratives

• BS+ in Science / Engineering (or related)
• 10-12 years GMP QA / QMS with change control leadership experience
• Demonstrated ability to lead cross-functional governance and risk-based decision making

• Experience in pharmaceutical / biotech post-approval change governance and external manufacturing changes (preferred)
• Experience with eQMS configuration and workflow optimization

• Change control governance, risk-based impact assessment, and implementation readiness criteria, predictable throughput management
• Cross-functional leadership, escalation, and executive-ready risk / decision communication
• Change management (stakeholder mapping, communications, training / SOP readiness, adoption measurement) for change process discipline
• Partner governance and performance management across sites / CMOs for…