Director, Product Quality Leader (PQL)

Role: Serve as a technical quality expert for biologics during clinical development through post-commercialization, acting as the single point of contact for all quality aspects within the CMC team. Responsibilities: lead product-specific quality strategies, support product lifecycle management, develop and oversee risk management, establish quality specifications and comparability protocols, interpret regulatory guidelines, and ensure compliance for regulated submissions and commitments. Requirements: BA/BS in life sciences; 12+ years in biotech/pharma, with biologics product development and lifecycle experience, including clinical and commercial phases. Skilled in cGMP, regulatory standards, and cross-functional collaboration. Preferences: experience with combination products, device considerations, and international regulations. High-Value: biologics, regulatory compliance, product lifecycle management, CMC leadership, cross-functional stakeholder engagement. Work setup involves periodic travel; role is embedded within the Technical Operations framework.