Madrigal Pharmaceuticals
Executive Director, Development Quality Lead
PA - Conshohocken - Office, USA · Director · Full-time
Sponsorship not specified$277k-$338kDetected 27 days ago
CompensationCadenceFDA 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
- Support tech transfer and scale-up readiness planning with CMC / clinical supply stakeholders
- Partner / Vendor Oversight & Inspection Readiness
- Oversee development partners / vendors as applicable, drive issue resolution and oversight governance
- Maintain inspection readiness plans, evidence packages, and training / standards for development quality
Nice to have
- Experience in pharmaceutical / biotech development quality and supporting development inspections / submission readiness (preferred)
- Development QA governance, phase-appropriate oversight, and readiness milestone management, documentation traceability discipline
- Cross-functional leadership, escalation, and executive-ready risk / decision communication
- Control strategy evolution partnering with CMC and clinical supply, tech transfer / scale-up readiness alignment
- Veeva Vault Quality (eQMS) proficiency to manage development QMS records and inspection-ready traceability
- Key Competencies
- By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization.
- We comply with all applicable minimum wage laws.
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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This listing is sourced directly from Madrigal Pharmaceuticals's careers page and normalized into a canonical job model.