At a Glance
- Tasks: Lead quality strategy and regulatory risk governance for innovative biological products.
- Company: Join a leading company in the life sciences industry with a focus on quality.
- Benefits: Competitive salary, travel opportunities, and professional growth.
- Other info: Collaborate with global teams and drive improvements in regulated product portfolios.
- Why this job: Make a significant impact on product quality and patient safety in a dynamic environment.
- Qualifications: Bachelor’s degree and 10+ years in quality or technical operations.
The predicted salary is between 121500 - 148500 $ per year.
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.
Director Quality Science Technology in Montague employer: Allozymes
BIOVECTRA, now part of Agilent, is an exceptional employer located in Windsor, NS and Charlottetown, PEI, offering a dynamic work culture that prioritizes innovation and collaboration. Employees benefit from competitive compensation, comprehensive health benefits, and opportunities for professional growth within the cutting-edge field of advanced manufacturing. Joining our team means contributing to meaningful advancements in patient care while working alongside dedicated professionals in a supportive environment.
