Associate Director, Development Quality – OSD at Madrigal Pharmaceuticals in Conshohocken, PA

Job description

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. Provides modality-focused development QA leadership for oral programs, ensuring phase-appropriate oversight, risk management, and compliant execution across internal teams and external partners. Owns program-level quality strategy, governance cadence, and readiness milestones and ensures development documentation is traceable and inspection-ready. Partners with CMC and clinical supply stakeholders on control strategy evolution, tech transfer readiness, and issue management. Supports efficient progression toward commercialization while maintaining compliance and predictable execution. Key Responsibilities Program QA Leadership (Oral) Own quality strategy, governance cadence, and risk register for assigned oral programs, define and track readiness milestones Guide application of QMS processes (deviations / CAPA / change control) in development context and ensure timely closure Produce deliverables such as program quality plans, readiness trackers, and decision / action logs Partner Oversight & Inspection Readiness Oversee external vendors / CMOs supporting oral development activities as applicable, ensure governance and escalation pathways Maintain inspection-ready documentation, narratives, and evidence packages for program scope Produce deliverables such as vendor governance packs, audit readiness checklists, and inspection evidence indexes Required Qualifications BS+ Life Sciences / Engineering (or related) 10–12 years QA experience with development-stage oversight Demonstrated cross-functional leadership and risk-based judgment Preferred Qualifications Experience in pharmaceutical / biotech oral product development and clinical supply interfaces (preferred) Experience with external development networks and inspection support Key Competencies Development QA governance, phase-appropriate oversight, and readiness milestone management for oral programs Change management (impact assessment, stakeholder mapping, communications, training / SOP readiness, adoption measurement) Partner governance and performance management across CMOs / vendors, inspection readiness evidence discipline Cross-functional leadership, escalation, and executive-ready risk / decision communication Quality risk management, issue triage, and timely action closure across development stakeholders Veeva Vault Quality (eQMS) proficiency to track program quality events, vendor oversight, and readiness documentation Madrigal’s Total Rewards strategy is based on a biotech industry peer group comparator and is inclusive of base pay, bonus and equity. Our equity offers meaningful opportunity allowing our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization. All employees receive equity, which we believe reinforces our ownership culture.