Madrigal Pharmaceuticals
Senior Manager, GMP Quality Assurance
PA - Pennsylvania – Remote, USA · Senior · Full-time
Sponsorship not specified$147k-$180kDetected 27 days ago
Product ManagementNegotiationSupply ChainPerformance ManagementGMPFDA 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
- 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
- Drive management and resolution of deviations and change controls with contractors and CMOs. Assess impact of deviations and changes on product quality and compliance
- 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
- Owns and drives the Batch Disposition process within Veeva
- Escalate and manage critical quality risks impacting product supply or compliance
- Drive management and resolution of deviations and change controls with contractors and CMOs.
Nice to have
- Candidate should have experience managing commercial external manufacturers and QA review of batch documentation and quality events
- Must have strong interpersonal, negotiation, presentation, and communication skills
- Knowledge and expertise in principles and practice of current Good Manufacturing Practices (GMPs) from development through commercial applications
- Knowledge of FDA regulations and ICH Guidelines in the pharmaceutical and/or biotech manufacturing environment
- Knowledge of risk management.
- Ability to make rational, timely, and compliant risk-based decisions
- Strong deviation impact assessment capability and documentation rigor
- Experience with Veeva Quality/Docs and Veeva QMS modules is highly desirable
Compensation
- Madrigal offers a competitive Total Rewards strategy to attract and retain top talent and is inclusive of base pay, bonus, equity, and a generous benefits package.
Benefits
- Support responses to FDA, EMA, and/or other health authority inspections
- Ensures compliance to applicable regulations, including U.S. and global health authorities
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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