Director, Commercial Product Quality

About the role

This senior leadership position is responsible for ensuring the highest standards of quality, compliance, and operational excellence across commercial pharmaceutical manufacturing activities in Canada. You will oversee product quality from intermediates and APIs through drug product, packaging, labeling, and distribution, supporting the global commercialization of oncology and rare‑disease therapies.

Key responsibilities

• Lead and evolve global pharmaceutical quality systems across commercial manufacturing, ensuring compliance with GMP, ICH guidelines and international regulatory standards (FDA, EMA).
• Oversee quality assurance and control for intermediates, APIs, drug product, packaging, labeling and commercial distribution.
• Drive continuous‑improvement initiatives, embedding best practices and strengthening cross‑site alignment.
• Partner with manufacturing and cross‑functional teams to integrate quality requirements early in product development and lifecycle management.
• Establish analytical frameworks for quality issue resolution and capability development.
• Lead regulatory compliance strategy and ensure inspection readiness across all operations and partner networks.
• Maintain documentation and record‑keeping systems that meet global regulatory expectations.

Required profile

• 12+ years of experience in pharmaceutical or biotechnology quality, including 8+ years in leadership roles.
• Proven track record in regulated manufacturing environments and global organizations.
• Strong expertise in GMP, ICH guidelines and regulatory requirements of health authorities such as FDA and EMA.
• Ability to operate strategically and hands‑on, influencing cross‑functional teams worldwide.

Required skills

• Good Manufacturing Practice (GMP)
• International Conference on Harmonisation (ICH) guidelines
• FDA regulatory requirements
• EMA regulatory requirements
• Quality systems implementation and oversight
• Analytical problem‑solving frameworks for quality issues