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

Madrigal Pharmaceuticals

About The Position

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 for integrating 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.

Requirements

Bachelor’s or advanced degree in Life Sciences, Pharmacy, Nursing, or related discipline. Advanced degree preferred
12+ years in pharmaceutical or biopharmaceutical industry, including significant experience in post-marketing PV QA and at least 5 years in QA (GVP and GMP)
Demonstrated leadership in global PV QA programs and complaint systems
Proven experience leading and supporting regulatory inspections (FDA, EMA, MHRA, etc.) and implementing CAPAs
Strong understanding of ICH, GVP Modules, FDA 21 CFR, EU PV requirements , EU Vol4
Deep understanding of post-marketing pharmacovigilance processes and risk-based quality systems
Direct experience governing Product Quality Complaints and their interface with Safety and GMP systems
Lifecycle surveillance, trending, and signal triage across deviations / complaints / stability / APR-PQR, risk assessment and prioritization
Product quality governance, decision documentation, and action tracking, recurrence prevention and effectiveness verification
Cross-functional leadership, escalation, and executive-ready risk / decision communication
Inspection readiness narratives and evidence package discipline, rapid response coordination for emerging signals
Partner governance alignment for product issues across sites / CMOs (as applicable
Excellent communication, leadership, and stakeholder-management skills
Strong analytical, decision-making, and attention-to-detail skills

Responsibilities

Provide strategic and operational Quality oversight of global post-marketing pharmacovigilance systems, ensuring compliance with FDA, EMA, MHRA, ICH, and other global health authority requirements
Maintain and expand a robust global Quality PV framework to ensure processes align with GVP, ICH, and other quality system requirements across all markets
Serve as the primary Quality partner to Safety for governance of safety processes, including case management, signal management, aggregate reporting, and risk management activities
Lead Quality risk management for PV, including identification, mitigation, and escalation of compliance risks impacting patient safety
Lead and support regulatory inspections, audits, and health authority interactions related to PV
Develop 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 system
Monitor key quality metrics and PV system performance indicators to drive proactive compliance management
Provide Quality oversight of global literature surveillance processes, ensuring compliant identification, assessment, documentation, and reporting of safety information from scientific and medical literature.
Own 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 Affairs
Oversee 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 requirements
Oversee complaints trending and analysis to identify signals or emerging risks impacting product quality or patient safety.
Establish, maintain, and continuously improve PV-related quality systems, SOPs, and work instructions appropriate for a mid-sized, global organization.
Oversee deviations, investigations, CAPAs, change controls, and effectiveness checks related to PV and PQC activities.
Ensure inspection readiness through proactive gap assessments, internal audits, and compliance monitoring.
Develop and track meaningful quality metrics to support management review and decision-making.
Serve as the QA representative on the PV governance board and Safety Management Team
Provide Quality input to safety agreements and vendor Quality oversight for global service providers
Provide Quality Oversight of PV and complaint-related vendors, service providers, and partners.
Lead qualification, auditing, and ongoing performance monitoring of external PV vendors.
Review and approve quality agreements and ensure clear delineation of roles and responsibilities for PV service providers.
Lead and mentor a global team of PV QA professionals.
Function as a key Quality liaison to Safety, Manufacturing, Supply Chain, Regulatory Affairs, Medical Affairs, and Commercial teams.
Provide guidance and training to internal stakeholders on PV and complaint-related quality requirements.
Contribute to governance forums and leadership discussions impacting product quality, patient safety, and compliance.
Drive strategic quality initiatives to strengthen compliance culture and inspection readiness.
Partner with senior leadership to shape the Quality vision and support global commercial growth.