Madrigal Pharmaceuticals
Associate Director, Quality Change Management
PA - Conshohocken - Office, USA · Director · Full-time
Sponsorship not specifiedDetected 27 days ago
Supply ChainPerformance ManagementCompensationGMPFDA RegulatoryLeadershipCommunication
About the role
- Every member of our Madrigal team is connected by our shared purpose: leading the fight against 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).
Responsibilities
- Own change control standards, templates, decision rights, and review cadences, ensure consistent risk-based assessments
- Cross-Functional & Partner Alignment
- Coordinate change reviews across Quality / CMC / MSAT / Supply Chain and external partners, align timelines and dependencies
- Own change KPIs and continuous improvement actions, drive predictable throughput without compromising quality
Requirements
- 10-12 years GMP QA / QMS with change control leadership experience
Nice to have
- 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
- Inspection readiness traceability, documentation rigor, and effectiveness / verification discipline
- Veeva Vault Quality (eQMS) proficiency to manage change controls end-to-end (risk, approvals, traceability, closure)
- Key Competencies
Compensation
- Madrigal's Total Rewards strategy is based on a biotech industry peer group comparator and is inclusive of base pay, bonus and equity.
Company info
- 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.
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