Biologics Quality Regulatory Director
Allozymes
Shape biologics quality strategy, GMP readiness, and regulatory risk decisions across Agilent Therapeutic Division’s product portfolio. This senior executive role operates with significant autonomy.
The Director, Quality Science & Technology provides quality leadership for biological drug substances, reagents, and complex chemistry molecules. You will guide design, development, scale-up, technology transfer, commercialization, and post-market sustainment. Success requires influence across Product Development, Manufacturing, Regulatory Affairs, Supply Chain, Clients, and Global Quality.
Key Responsibilities:- Establish science-based quality strategies for regulated product portfolios
- Guide development protocols, specifications, validation, and GMP readiness
- Assess changes through risk evaluation and impact assessment
- Maintain the Quality Management System against applicable standards
- Communicate quality metrics and regulatory insights to senior leadership
- Engineering, life sciences, or related bachelor’s degree required
- Master’s or PhD preferred
- 10+ years supporting biological or pharmaceutical environments
- Leadership experience in global, complex, matrixed organizations
- ASQ certification or Six Sigma credentials preferred
Bring biologics quality leadership, GMP knowledge, and regulatory judgment to lifecycle decisions across Agilent’s therapeutic portfolio.
#J-18808-LjbffrVacancy posted 1 hour ago
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