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
Requirements:
- 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-Ljbffr
📌 Biologics Quality Regulatory Director (Charlottetown)
🏢 Allozymes
📍 Charlottetown
Reply to this offer
Impress this employer describing Your skills and abilities, fill out the form below and leave Your personal touch in the presentation letter.