Senior Director, Product Quality Lead (Post-Marketing and Pharmacovigilance
Core
Lead and mature the global post-marketing pharmacovigilance (PV) quality function, ensuring compliance with global regulatory expectations while enabling scalable operations for a biopharmaceutical company treating MASH.
Role type
Senior Director, Product Quality Lead (Post-Marketing and Pharmacovigilance)
Builds
Global PV quality frameworks, compliant complaint systems, and inspection-ready evidence packages for a novel therapeutic (Rezdiffra) targeting liver disease.
Domain
Biopharmaceuticals / Pharmacovigilance / Regulatory Compliance
Deliverable
client delivery
Required skills
GVP, GXP, global health authority expectations, risk-based PV QA systems, regulatory inspection leadership, CAPA management, deviation handling, literature surveillance governance, Product Quality Complaint (PQC) oversight, vendor qualification and auditing, cross-functional leadership, strategic quality planning.
Preferred skills
Advanced degree in Life Sciences/Pharmacy/Nursing, 12+ years in pharma/biopharma with 5+ in QA, experience leading FDA/EMA/MHRA inspections, deep knowledge of ICH GVP Modules, FDA 21 CFR, EU PV requirements, EU Vol4.
Technologies
None explicitly stated
Responsibilities
Provide strategic and operational Quality oversight of global post-marketing PV systems; Lead Quality risk management for PV including identification and mitigation of compliance risks; Lead and support regulatory inspections, audits, and health authority interactions; Develop and execute the global PV audit strategy; Own and govern the global Product Quality Complaint process; Establish and maintain PV-related quality systems, SOPs, and work instructions; Lead and mentor a global team of PV QA professionals.
Seniority
Senior Director, strategic leadership with hands-on operational oversight
