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

Madrigal Pharmaceuticals is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH). They are seeking a Senior Director, Product Quality Lead to oversee post-marketing pharmacovigilance activities, ensuring compliance with global regulatory expectations while enabling efficient operations.

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
• 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

Requirements:

• Bachelor's or advanced degree in Life Sciences, Pharmacy, Nursing, or related discipline
• 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