Director, Product Quality Lead

Role: Product Quality Lead within Quality Sciences and Knowledge Management, focusing on advancing global quality initiatives and ensuring product compliance and excellence in a biopharma setting. Responsibilities: drive risk management, oversee investigations and change controls, support CMC strategies for late-phase clinical or commercial biologics, contribute to quality performance monitoring, lead or participate in cross-functional quality system improvements, and ensure regulatory inspection readiness. Collaborate across R&D, manufacturing, and regulatory teams to embed quality standards in product development and lifecycle management. Requirements: Bachelor's degree in life sciences or related field with 8+ years of relevant industry experience; advanced degree and 10+ years preferred; 5+ years of managerial experience; deep expertise in quality systems, risk management frameworks (e.g., ICH Q9), and regulatory compliance (FDA, EMA). Skills in quality investigations, technological innovations, and global training are essential. High-Value: biologics, late-stage clinical (Phases 2-3) or commercial products, CMC strategies, risk management, regulatory inspections, and global quality governance. WorkSetup: Hybrid with up to 20% travel.