Madrigal Pharmaceuticals
Senior Manager, Deviation Management – Quality Assurance
PA - Conshohocken - Office, USA · Senior · Full-time
Sponsorship not specified$148k-$180kDetected 27 days ago
Performance ManagementCompensationCadenceGMPFDA RegulatoryLeadershipCommunicationProblem Solving
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 deviation standards, templates, training expectations, and governance cadence (triage, backlog, aging, escalation)
- Ensure consistent severity classification and impact assessment expectations across teams / sites / partners
- Drive RCA rigor and evidence standards, coach investigators and ensure high-quality conclusions and documentation
- Own deviation trending and management review inputs, identify systemic themes and drive cross-functional actions
- Maintain inspection-ready deviation records and process narratives, support audits / inspections and responses
Requirements
- 7-10 years in GMP QA / QMS with strong deviation / investigation leadership experience
Nice to have
- Experience with eQMS workflows and continuous improvement / problem-solving facilitation
- Deviation governance, investigation quality standards, and cycle-time / backlog management, escalation, and action closure discipline
- RCA facilitation, CAPA linkage, and effectiveness verification, recurrence prevention, and trending insights
- Cross-functional leadership, escalation, and executive-ready risk / decision communication
- Inspection readiness documentation rigor, audit narrative development, and evidence retrieval readiness
- Veeva Vault Quality (eQMS) proficiency to drive deviation workflow execution, CAPA linkage, and trending
- Key Competencies
- By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization.
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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