We are seeking a strategic leader to oversee Quality Assurance/Control, Regulatory Affairs, and Patient Safety for our Canadian affiliate. This role is responsible for ensuring the highest standards of product quality, regulatory compliance, and patient trust across our operations.
Key Responsibilities
Lead Quality Management System (QMS) oversight, inspections, deviation/complaint investigations, CAPA, and audit readiness.
Act as Site Quality Leader/Product Quality Representative, ensuring GxP compliance across importation, distribution, commercialization, and third-party partners.
Provide strategic direction for regulatory submissions, labeling, lifecycle management, and interactions with Health Canada.
Ensure compliant pharmacovigilance and timely reporting of adverse events and product complaints.
Serve as Senior Person in Charge (SPIC) for controlled substances, ensuring security and compliance.
Lead and develop a high-performing Quality, Regulatory, and Safety team.
Partner cross-functionally to support business goals while maintaining full compliance.
Qualifications
Advanced degree in Life Sciences, Pharmacy, or related field (Master’s/PharmD/PhD preferred).
10+ years of progressive leadership experience in pharmaceutical Quality, Regulatory Affairs, and Safety.
Expertise in Health Canada regulations, GMP, GCP, GDP, and pharmacovigilance.
Proven success managing inspections, recalls, and compliance programs.
Strong leadership, communication, and cross-functional collaboration skills.
This role is ideal for a visionary, hands-on leader who can drive excellence, influence global strategy, and champion a culture of patient safety and quality.
