Senior Director, Product Quality Lead (Post-Marketing and Pharmacovigilance

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.Position Summary We are seeking an experienced Senior Director, Product Quality Lead( Post-Marketing and Pharmacovigilance Quality) to lead and mature our global PV Quality function during an exciting phase of global commercial growth.This role provides strategic direction and operational Quality leadership and oversight of post-marketing pharmacovigilance activities, ensuring sustained compliance with global regulatory expectations while enabling efficient, scalable operations. As a key member of the Quality leadership team, you will partner closely with Pharmacovigilance, Regulatory Affairs, Manufacturing, and Commercial teams to embed quality across the full product lifecycle, with particular focus on post-marketing safety surveillance, literature monitoring, and Product Quality Complaints (PQC).This is a hands-on, strategic leadership role responsible for shaping risk-based PV QA systems, and mentoring a team committed to world-class patient safety practices. The position will be responsible forintegrating signals from deviations, complaints, stability, and APR / PQR to proactively identify and mitigate risk. Establishes product-specific quality strategies and leads cross-functional product quality forums with decision logs and action tracking. Maintains inspection readiness through robust product quality narratives and evidence packages. Supports rapid response to emerging product quality concerns and ensures actions are implemented effectively.The ideal candidate will bring deep expertise in GVP, GXP, and global health authority expectations, with proven experience in building and maintaining compliant, efficient, and risk-based PV QA systems.Key ResponsibilitiesPharmacovigilance Quality OversightProvide strategic and operational Quality oversight of global post-marketing pharmacovigilance systems, ensuring compliance with FDA, EMA, MHRA, ICH, and other global health authority requirementsMaintain and expand a robust global Quality PV framework to ensure processes align with GVP, ICH, and other quality system requirements across all marketsServe as the primary Quality partner to Safety for governance of safety processes, including case management, signal management, aggregate reporting, and risk management activitiesLead Quality risk management for PV, including identification, mitigation, and escalation of compliance risks impacting patient safetyLead and support regulatory inspections, audits, and health authority interactions related to PVDevelop and execute the global PV audit strategy and risk-based audit program covering internal processes, affiliates, vendors, and partners.Partner with PV operations to ensure effective CAPA management, deviation handling, and continuous improvement of the PV systemMonitor key quality metrics and PV system performance indicators to drive proactive compliance managementProvide Quality oversight of global literature surveillance processes, ensuring compliant identification, assessment, documentation, and reporting of safety information from scientific and medical literature.Product Quality Complaints (PQC) oversightOwn and govern the global Product Quality Complaint process, ensuring compliant intake, investigation, documentation, trending, and closure.Ensure appropriate assessment of PQCs for potential safety impact, with timely escalation to Pharmacovigilance and Regulatory AffairsEnsure appropriate assessment of PQCs for potential safety impact, with timely escalation to Pharmacovigilance and Regulatory AffairsOversee PQC processes across internal teams and external partners, ensuring alignment with GMP, GDP, and PV requirements.Lead complaint system KPI and metrics to identify systemic issues and drive continuous improvement.Maintenance of a validated global Product Quality Complaint system in compliance with GXP requirementsOversee complaints trending and anal