Director Quality Science & Technology

Location: Charlottetown, Prince Edward Island, Canada; remote work option available

Salary: CAD 130,944–204,600 per year, plus eligibility for bonus, stock, and benefits

Company

hirify.global’s Therapeutic Division develops and supports regulated biological drug substances, reagents, complex chemistry molecules, and associated services.

What you will do

• Own portfolio-level quality and compliance strategies for biological drug substances, reagents, and complex chemistry molecule manufacturing operations.
• Govern product, process, technology, regulatory, and patient or user safety risks across development, commercialization, post-market surveillance, and obsolescence.
• Provide executive oversight of design controls, quality engineering, validation strategies, specifications, process development, scale-up, technology transfer, and lifecycle management.
• Lead risk-based change control and lifecycle governance for regulated products.
• Maintain and evolve the Quality Management System in line with regulatory requirements and international standards.
• Build quality engineering capabilities, lead continuous improvement, reduce Cost of Poor Quality, and communicate quality metrics and risk insights to senior leadership.

Requirements

• Bachelor’s degree in engineering, life sciences, or a related discipline required; a Master’s degree or PhD is preferred.
• 10+ years of experience in quality and technical operations, process development, or manufacturing in biological and pharmaceutical environments.
• Experience managing quality and regulatory risk across biologics, peptides, polypeptides, or complex biological product lifecycles.
• Ability to lead through influence, governance, and technical expertise in complex, global, matrixed organizations, including CDMOs.
• Knowledge of quality systems, risk management, validation, supplier quality, statistical methods, ICH, Health Canada, FDA, and GMP requirements.
• Ability to support inspection readiness, audits, post-market surveillance, complaints, nonconformances, and regulatory compliance.

Nice to have

• Master’s degree or PhD in engineering, life sciences, or a related discipline.
• ASQ certification and/or Six Sigma credentials.

Culture & Benefits

• Full-time schedule with an option to work remotely.
• Eligibility for bonus, stock, and benefits.
• Occasional travel; day shift.
• Opportunity to influence quality, compliance, and patient safety across a regulated therapeutic portfolio.