27 Oct
|
Allozymes
|
Charlottetown
27 Oct
Allozymes
Charlottetown
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 Management
- Escalate material quality, regulatory, and patient safety risks
- Oversee design controls, development risks, and quality engineering
- Lead change control, lifecycle governance, and technology transfers
- Drive post-market improvement using complaints, audits, and inspection data
Requirements:
- Bachelor’s degree in engineering, life sciences, or related discipline
- 10+ years in quality, technical operations, development, or manufacturing
- Experience managing biologics, peptides, or complex product lifecycles
- Knowledge of risk management, validation, supplier quality, and statistics
- Working knowledge of ICH, Health Canada, FDA, and GMP requirements
Use quality science, regulatory expertise, and risk leadership to strengthen Agilent Technologies’ regulated product portfolios.
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📌 Director Quality Science Technology (Charlottetown)
🏢 Allozymes
📍 Charlottetown