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

Madrigal Pharmaceuticals seeks a Senior Director to lead post-marketing pharmacovigilance quality operations during global commercial expansion. This strategic role oversees compliance with global regulatory requirements, manages product quality complaints, and ensures patient safety through robust quality systems and risk management.

Responsibilities

• Provide strategic and operational quality oversight of global post-marketing pharmacovigilance systems and compliance
• Lead and govern product quality complaints process, including intake, investigation, trending, and safety assessment
• Establish and maintain pharmacovigilance quality systems, SOPs, and governance frameworks
• Oversee deviation management, CAPA processes, and continuous improvement initiatives
• Lead audit strategy and vendor oversight for pharmacovigilance and complaint-related service providers

Requirements

• Deep expertise in GVP, GXP, and global health authority regulations (FDA, EMA, MHRA, ICH)
• Proven experience building and maintaining compliant, risk-based pharmacovigilance quality assurance systems
• Leadership experience managing quality teams and cross-functional stakeholder engagement
• Strong knowledge of product quality complaints, deviation management, and CAPA processes
• Experience with inspection readiness, audit strategy, and regulatory interactions
• Demonstrated ability in literature surveillance and signal management oversight