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

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

Responsibilities
- Provide strategic and operational Quality oversight of global post-marketing pharmacovigilance systems (FDA, EMA, MHRA, ICH, and other global requirements)
- Maintain and expand a robust global Quality PV framework aligned to GVP/ICH and applicable quality system requirements
- Partner with Safety on safety governance (case management, signal management, aggregate reporting, risk management)
- Lead PV quality risk management (identify, mitigate, escalate patient-safety compliance risks)
- Lead/support regulatory inspections, audits, and health authority interactions for PV
- Develop/execute a global, risk-based PV audit strategy covering internal processes, affiliates, vendors, and partners
- Partner with PV operations on CAPA management, deviation handling, and PV continuous improvement
- Monitor quality metrics and PV performance indicators
- Provide Quality oversight of global literature surveillance processes
- Own/govern global Product Quality Complaint (PQC) process (intake, investigation, documentation, trending, closure) and ensure proper safety-impact assessment/escalation
- Maintain a validated global PQC system (GxP)
- Oversee deviations/investigations/CAPAs/change controls/effectiveness checks related to PV and PQC
- Ensure inspection readiness via gap assessments, internal audits, and compliance monitoring
- Lead and mentor a global team of PV QA professionals; liaison with Safety, Manufacturing, Supply Chain, Regulatory, Medical, and Commercial
- Provide guidance/training; drive quality initiatives; support global commercial growth
- Provide Quality oversight of PV/complaint vendors (qualification, auditing, performance monitoring) and review/approve quality agreements

Qualifications (Preferred)
- Bachelor’s or advanced degree in Life Sciences, Pharmacy, Nursing, or related field (advanced degree preferred)
- 12+ years in pharma/biopharma, including significant post-marketing PV QA experience and at least 5 years in QA (GVP and GMP)
- Demonstrated leadership in global PV QA and complaint systems
- Proven experience leading/supporting regulatory inspections (FDA/EMA/MHRA) and implementing CAPAs
- Strong knowledge of ICH, GVP Modules, FDA 21 CFR, EU PV requirements, EU Vol 4

Benefits
- Competitive Total Rewards: base pay, bonus, equity, and comprehensive benefits (flexible PTO; medical/dental/vision; life/disability; 401(k) with match; plus other voluntary/mental health benefits).

Application
- Apply via the Madrigal Careers site (applications accepted on an ongoing basis).