Associate Director, GLP Quality

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.

We are seeking an experienced Senior Manager, GLP Quality to provide phase-appropriate quality oversight for non-clinical development activities across a growing portfolio of programs. This role requires strong knowledge of US and EU regulatory expectations, risk-based vendor oversight, and the ability to operate effectively in a virtual biotech environment with a global network of CROs, laboratories, consultants, and development partners.

The Senior Manager will lead GLP quality oversight for regulated non-clinical studies and external partners, ensuring compliance, documentation integrity, and inspection readiness. This individual will drive audit strategy, issue management, CAPA effectiveness, and continuous improvement while partnering cross-functionally with Development, Regulatory, CMC, Technical Operations, Clinical, and external vendors to support progression of key programs (e.g., Investigational New Drug (IND) submissions).

Key Responsibilities

GLP Oversight & Vendor Governance

• Lead quality oversight of non-clinical studies conducted at CROs, contract laboratories, bioanalytical laboratories, toxicology sites, and other external partners supporting development programs
• Develop and maintain a risk-based vendor oversight model, including qualification, onboarding, performance monitoring, audits, issue escalation, and periodic review
• Plan, conduct, and manage GxP audits; drive timely closure of findings and CAPAs with effectiveness verification
• Review study- and vendor-related quality documentation, including protocols, reports, deviations, CAPAs, change controls, quality agreements, and data integrity concerns, as applicable

Issue Management, Inspection Readiness & QMS Support

• Lead investigations, root cause analysis, and CAPA activities associated with non-clinical quality events and vendor performance issues, including trending and recurrence prevention
• Maintain inspection readiness for non-clinical activities through controlled documentation, evidence packages, and support for regulatory inspections, partner audits, and due diligence reviews
• Provide guidance and training to internal teams and external partners to reinforce GLP expectations, documentation discipline, and quality standards
• Contribute to the design, implementation, and continuous improvement of phase-appropriate QMS processes relevant to non-clinical development in a virtual company model

Cross-Functional Partnership

• Provide quality input to governance forums, program teams, and functional leadership on compliance risks, mitigation strategies, and business impact
• Partner with Regulatory Affairs to support quality aspects of IND, CTA, IMPD, NDA/BLA/MAA, or related submissions
• Collaborate across Development, CMC, Technical Operations, and Clinical to ensure quality interfaces are managed effectively across development programs
• Support the build-out of scalable quality infrastructure and mentor junior team members as needed

Required Qualifications

• BS in Life Sciences or related discipline; advanced degree preferred
• 10+ years of GLP QA or non-clinical quality experience, including audit and vendor oversight responsibilities
• Strong knowledge of applicable US and EU regulatory requirements for non-clinical development and GLP-regulated activities
• Demonstrated experience overseeing outsourced activities in a virtual or highly outsourced biotech or pharmaceutical environment
• Strong risk-based judgment, documentation integrity, and issue management capability