Lead portfolio quality strategy and regulatory risk governance for biological drug substances, reagents, and complex chemistry molecules. This full time role includes occasional travel.As a senior quality executive, you will guide lifecycle readiness from development through commercialization, post-market surveillance, and obsolescence. You will influence global, matrixed teams through governance, technical authority, and executive partnership. The scope includes quality systems, risk management, validation, and regulatory compliance.Key Responsibilities: Own portfolio quality and compliance strategies using Quality Risk ManagementEscalate material quality, regulatory, and patient safety risksOversee design controls, development risks, and quality engineeringLead change control, lifecycle governance,



and technology transfersDrive post-market improvement using complaints, audits, and inspection dataRequirements: Bachelor’s degree in engineering, life sciences, or related discipline10+ years in quality, technical operations, development, or manufacturingExperience managing biologics, peptides, or complex product lifecyclesKnowledge of risk management, validation, supplier quality, and statisticsWorking knowledge of ICH, Health Canada, FDA, and GMP requirementsUse quality science, regulatory expertise, and risk leadership to strengthen Agilent Technologies’ regulated product portfolios.#J-18808-Ljbffr

📌 Director Quality Science Technology (Montague)
🏢 Allozymes
📍 Montague