Madrigal Pharmaceuticals
Senior Director, Product Quality Lead (Post-Marketing and Pharmacovigilance
PA - Pennsylvania – Remote, USA · Director · Full-time
Sponsorship not specified$244k-$299kDetected 27 days ago
Product ManagementAuditingSupply ChainGMPFDA RegulatoryPharmacovigilanceLeadershipCommunicationMentoringGxPRegulatory Affairs
About the role
- 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.
- 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.
- integrating signals from deviations, complaints, stability, and APR / PQR to proactively identify and mitigate risk.
Responsibilities
- 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
- 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
- Own and govern the global Product Quality Complaint process, ensuring compliant intake, investigation, documentation, trending, and closure.
- 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.
- Establish, maintain, and continuously improve PV-related quality systems, SOPs, and work instructions appropriate for a mid-sized, global organization.
Nice to have
- 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
- Key Competencies
- Deep understanding of post-marketing pharmacovigilance processes and risk-based quality systems
Compensation
- Madrigal offers a competitive Total Rewards strategy to attract and retain top talent and is inclusive of base pay, bonus, equity, and a generous benefits package.
Benefits
- 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
- Lead and support regulatory inspections, audits, and health authority interactions related to PV
- Provide Quality oversight of global literature surveillance processes, ensuring compliant identification, assessment, documentation, and reporting of safety information from scientific and medical literature.
Company info
- 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.
- 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.
- Lead and mentor a global team of PV QA professionals.
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