Senior Director, Product Quality Lead (Post-Marketing and Pharmacovigilance
Madrigal Pharmaceuticals
June 30, 2026
Remote friendly (Pennsylvania Furnace, PA)
United States
Medical Affairs
Position Summary
Senior Director, Product Quality Lead (Post-Marketing and Pharmacovigilance Quality) to lead and mature global PV Quality.
Responsibilities
- Provide strategic/operational Quality oversight of global post-marketing pharmacovigilance (PV) systems; ensure compliance with FDA, EMA, MHRA, ICH, and other health authority requirements.
- Maintain/expand global PV Quality framework aligned to GVP/ICH.
- Serve as primary Quality partner to Safety for safety governance (case/signal/aggregate reporting/risk management).
- Lead PV Quality risk management (identify, mitigate, escalate compliance risks impacting patient safety).
- Lead/support PV-related regulatory inspections, audits, and health authority interactions; develop/execute global PV audit strategy.
- Partner with PV operations on CAPA, deviation handling, and continuous improvement; monitor PV quality metrics.
- Provide Quality oversight of literature surveillance.
- Own/govern global Product Quality Complaint (PQC) process (intake, investigation, documentation, trending, closure); ensure PQC assessment/escalation for safety impact.
- Establish/improve PV-related quality systems/SOPs; oversee deviations, investigations, CAPAs, change controls, effectiveness checks.
- Ensure inspection readiness; develop/track quality metrics for management review.
- Lead qualification/auditing/performance monitoring of PV/complaint vendors; review/approve quality agreements.
- Lead/mentor global PV QA team; train stakeholders; support governance forums and quality vision.
Preferred Qualifications
- Bachelor’s or advanced degree in Life Sciences/Pharmacy/Nursing (advanced preferred).
- 12+ years in pharma/biopharma; significant post-marketing PV QA experience; 5+ years in QA (GVP/GMP).
- Leadership in global PV QA and complaint systems; experience with FDA/EMA/MHRA inspections and CAPAs.
Key Skills/Competencies
- Post-marketing PV and risk-based quality systems; PQC–Safety–GMP interfaces.
- Lifecycle surveillance/trending/signal triage; risk assessment/prioritization.
- PV/product quality governance, decision documentation, action tracking, recurrence prevention.
- Executive-ready communication and inspection readiness (narratives/evidence packages).
Benefits (as stated)
- Base salary estimate: $244,000–$299,000/year; equity, bonus.
- Comprehensive benefits: flexible paid time off, medical/dental/vision, life/disability, 401(k) (incl. match), voluntary benefits, and EAP mental health support.
Application Instructions
- Apply on an ongoing basis via the Madrigal Careers site.
Senior Director, Product Quality Lead (Post-Marketing and Pharmacovigilance Quality) to lead and mature global PV Quality.
Responsibilities
- Provide strategic/operational Quality oversight of global post-marketing pharmacovigilance (PV) systems; ensure compliance with FDA, EMA, MHRA, ICH, and other health authority requirements.
- Maintain/expand global PV Quality framework aligned to GVP/ICH.
- Serve as primary Quality partner to Safety for safety governance (case/signal/aggregate reporting/risk management).
- Lead PV Quality risk management (identify, mitigate, escalate compliance risks impacting patient safety).
- Lead/support PV-related regulatory inspections, audits, and health authority interactions; develop/execute global PV audit strategy.
- Partner with PV operations on CAPA, deviation handling, and continuous improvement; monitor PV quality metrics.
- Provide Quality oversight of literature surveillance.
- Own/govern global Product Quality Complaint (PQC) process (intake, investigation, documentation, trending, closure); ensure PQC assessment/escalation for safety impact.
- Establish/improve PV-related quality systems/SOPs; oversee deviations, investigations, CAPAs, change controls, effectiveness checks.
- Ensure inspection readiness; develop/track quality metrics for management review.
- Lead qualification/auditing/performance monitoring of PV/complaint vendors; review/approve quality agreements.
- Lead/mentor global PV QA team; train stakeholders; support governance forums and quality vision.
Preferred Qualifications
- Bachelor’s or advanced degree in Life Sciences/Pharmacy/Nursing (advanced preferred).
- 12+ years in pharma/biopharma; significant post-marketing PV QA experience; 5+ years in QA (GVP/GMP).
- Leadership in global PV QA and complaint systems; experience with FDA/EMA/MHRA inspections and CAPAs.
Key Skills/Competencies
- Post-marketing PV and risk-based quality systems; PQC–Safety–GMP interfaces.
- Lifecycle surveillance/trending/signal triage; risk assessment/prioritization.
- PV/product quality governance, decision documentation, action tracking, recurrence prevention.
- Executive-ready communication and inspection readiness (narratives/evidence packages).
Benefits (as stated)
- Base salary estimate: $244,000–$299,000/year; equity, bonus.
- Comprehensive benefits: flexible paid time off, medical/dental/vision, life/disability, 401(k) (incl. match), voluntary benefits, and EAP mental health support.
Application Instructions
- Apply on an ongoing basis via the Madrigal Careers site.