Senior Manager, GMP Quality Assurance

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.

This role is a key member of the Quality Assurance team, responsible for quality oversight of external GMP manufacturers (CMOs/CDMOs) supporting commercial drug substance, drug product, and finished product.

This individual serves as the primary quality liaison across internal functions (e.g., MSAT, Supply Chain, Regulatory) and external partners to ensure compliance with global regulatory requirements and Madrigal’s Quality Management System.

The Senior Manager is expected to drive quality strategy, enable risk-based decision-making, and lead continuous improvement initiatives and lead GMP batch disposition for an expedited portfolio to enable timely, compliant release decisions that protect patient safety and ensure supply continuity. Establishes review standards, cycle-time expectations, and escalation pathways for exceptions, ensuring decisions are risk-based, consistent, and well documented. Partners with Manufacturing/CMOs, Quality Operations, and Supply Chain to improve right-first-time documentation and reduce disposition cycle time. Maintains inspection readiness through strong documentation control, traceable decision rationales, and clear release narratives. Drives continuous improvement to reduce recurring documentation errors and ensures timely deviation management to ensure continuous supply.

This position provides end-to-end quality oversight across the commercial supply chain, including batch disposition, external quality event management, and inspection readiness.

Key Responsibilities

Product Quality and Disposition

• Lead batch record review strategy and ensure consistent, compliant, well-documented release decisions
• Leads the review and disposition of commercial batch records for API intermediates, API, drug product, and finished product
• Own quality oversight of external manufacturers, including performance trending and governance

Manufacturing and External Partner Oversight

• Ensure quality oversight across the commercial product lifecycle, including PPQ, routine manufacturing, and post-approval changes
• Ensure effectiveness of Quality Agreements
• Drive management and resolution of deviations and change controls with contractors and CMOs.  Assess impact of deviations and changes on product quality and compliance

Quality Systems, Compliance, and Inspection Readiness

• Oversee documentation and closure of external deviations and change control in the QMS
• Maintain inspection-ready disposition evidence packages and support audit responses 
• Drive right-first-time documentation improvements with Ops / CMOs to reduce repeat errors and delays 
• Produce deliverables such as RFT and SOP/WI updates to ensure compliance
• Make risk-based quality decisions impacting product disposition and supply continuity
• Owns and drives the Batch Disposition process within Veeva
• Provide quality oversight of late stage / clinical manufacturing activities supporting commercial supply, as applicable

Risk Management and Continuous Improvement

• Escalate and manage critical quality risks impacting product supply or compliance
• Support internal and external audits/inspections as requested. Support responses to FDA, EMA, and/or other health authority inspections
• Ensures compliance to applicable regulations, including U.S. and global health authorities
• Provide quality leadership and influence cross-functional decision making to ensure compliant and efficient supply of commercial products

Preferred Qualifications

• BS