Senior Manager, GMP Quality Assurance

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. Role Overview This role is a key member of the Quality Assurance team, responsible for quality oversight of external GMP manufacturers (CMOs/CDMOs) supporting commercial drug substance, drug product, and finished product. This individual serves as the primary quality liaison across internal functions (e.g., MSAT, Supply Chain, Regulatory) and external partners to ensure compliance with global regulatory requirements and Madrigal’s Quality Management System. The Senior Manager is expected to drive quality strategy, enable risk‑based decision‑making, and lead continuous improvement initiatives and lead GMP batch disposition for an expedited portfolio to enable timely, compliant release decisions that protect patient safety and ensure supply continuity. Establishes review standards, cycle‑time expectations, and escalation pathways for exceptions, ensuring decisions are risk‑based, consistent, and well documented. Partners with Manufacturing/CMOs, Quality Operations, and Supply Chain to improve right‑first‑time documentation and reduce disposition cycle time. Maintains inspection readiness through strong documentation control, traceable decision rationales, and clear release narratives. Drives continuous improvement to reduce recurring documentation errors and ensures timely deviation management to ensure continuous supply. Product Quality and Disposition Lead batch record review strategy and ensure consistent, compliant, well‑documented release decisions. Lead 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 Ensure quality oversight across the commercial product lifecycle, including PPQ, routine manufacturing, and post‑approval changes. Ensure effectiveness of Quality Agreements. Drive management and resolution of deviations and change controls with contractors and CMOs. Assess impact of deviations and changes on product quality and compliance. Quality Systems, Compliance, and Inspection Readiness Oversee documentation and closure of external deviations and change control in the QMS. 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. Produce deliverables such as RFT and SOP/WI updates to ensure compliance. Make risk‑based quality decisions impacting product disposition and supply continuity. Owns and drives the Batch Disposition process within Veeva. Provide quality oversight of late stage / clinical manufacturing activities supporting commercial supply, as applicable. Risk Management and Continuous Improvement Escalate and manage critical quality risks impacting product supply or compliance. Support internal and external audits/inspections as requested. Support responses to FDA, EMA, and/or other health authority inspections. Ensures compliance to applicable regulations, including U.S. and global health authorities. Provide quality leadership and influence cross‑functional decision making to ensure compliant and efficient supply of commercial products. Qualifications BS or MSc in a scientific discipline, with at least 7 years of experience in GMP pharmaceutical/biotech manufacturing, including disposition / release or quality operations and oversight of external CMOs/CDMOs for commercial products. Experience managing commercial external manufacturers and QA review of batch documentation and quality events. Strong interpersonal, negotiation, presentation, and communication skills. Strong knowledge of design, development, and/or reviews of QA standards and procedures (e.g., policy documents and SOPs). 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. Skilled in developing collaborative internal and external relationships. Experience with Veeva Quality/Docs and Veeva QMS modules is highly desirable. Experience in pharmaceutical / biotech manufacturing networks and external manufacturing batch release interfaces (preferred). Experience supporting inspections with batch disposition narratives and evidence packages. Key Competencies RCA facilitation, CAPA linkage, and effectiveness verification, recurrence prevention, and trending insights. Partner governance and performance management across sites / CMOs for deviation quality and responsiveness (as applicable). Inspection readiness documentation rigor, audit narrative development, and evidence retrieval readiness. Benefits & Compensation Competitive Total Rewards strategy to attract and retain top talent – base pay, bonus, equity, and a generous benefits package. Full‑time employees are eligible for base salary, bonus, equity, and a comprehensive benefits suite. Base salary determined by candidate’s qualifications, skills, education, experience, business needs, and market demands – good faith estimate: $147,000 – $180,000 per year. Equity, flexible paid time off, medical, dental, vision, life/disability insurance, 401(k) offerings (traditional, Roth, and employer match). Additional voluntary benefits: supplemental life insurance, legal services, and other offerings. Mental health benefits through our Employee Assistance Program for employees and their family. Additional benefits in accordance with applicable federal, state, and local laws. Committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process. Equal Opportunity & Application Security Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristics protected by applicable federal, state, or local law. We are committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process. If you need assistance, please contact View email address on click.appcast.io. Applications are being accepted on an ongoing basis and can be submitted through our Madrigal Careers site. Please be aware that we have received reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals’ Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites… Any correspondence with regard to employment would come from an authorized madrigalpharma.com email address. We recommend that you do not respond to unsolicited offers or open suspicious attachments. For questions regarding the legitimacy of job‑related contacts, contact View email address on click.appcast.io. #J-18808-Ljbffr