Madrigal Pharmaceuticals
Associate Director, GLP Quality
PA - Conshohocken - Office, USA · Director · Full-time
Sponsorship not specified$163k-$200kDetected 27 days ago
AuditingClinical TrialsFDA RegulatoryLeadershipCommunicationProblem SolvingGxPRegulatory Affairs
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 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
- 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
- Partner with Regulatory Affairs to support quality aspects of IND, CTA, IMPD, NDA/BLA/MAA, or related submissions
Requirements
- 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
Nice to have
- Hands-on experience auditing and managing CROs, contract laboratories, and other GxP vendors supporting non-clinical programs
- Experience supporting cross-functional quality interfaces spanning non-clinical, CMC, and clinical development
- Experience in a mid-sized biotech with both commercial and development-stage assets
- Deep knowledge of non-clinical quality, GLP oversight, and vendor governance
- Strong risk assessment, decision-making, and problem-solving capability
- Inspection readiness and audit leadership with a focus on pragmatic, compliant execution
- Key Competencies
- We comply with all applicable minimum wage laws.
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.
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.