Sr. Director - Patient Safety and Quality

Sr. Director - Patient Safety and Quality page is loaded## Sr. Director - Patient Safety and Quality locations:
CA:
Toronto ONtime type:
Full time posted on:
Posted Yesterday job requisition :
R-93579

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first.

We’re looking for people who are determined to make life better for people around the world.

The Senior Director, Patient Safety & Quality is the accountable affiliate leader for ensuring the highest standards of product quality, patient safety, and pharmacovigilance across the organization. This role provides strategic and operational leadership for Quality Assurance/Control, Safety/Pharmacovigilance, and Complaints, ensuring robust systems, inspection readiness, and sustained compliance with corporate standards and applicable Canadian requirements.
As a member of the medical leadership team, this role shapes local quality and safety strategy, partners closely with global functions, and enables business execution while safeguarding patient trust and product integrity.

This is a hybrid role – onsite presence at our Toronto office will be 10 days or more per month (or at least 50% of the time), determined in collaboration with your manager and based on business needs.

This role is eligible for additional forms of compensation, such as participation in the Lilly Bonus Program and a car allowance.

This posting is for an existing vacancy.
** Key Responsibilities**## Quality Leadership
• Act as the Affiliate Quality Leader / Product Quality Representative, with end-to-end accountability for GxP quality across importation, distribution, commercialization, and sampling activities.  
• Own and continuously enhance the Quality Management System (QMS), including deviation management, CAPA effectiveness, change control, data integrity, and management review.  
• Ensure ongoing inspection readiness, including leadership of affiliate responses to inspections, audits, and quality-related inquiries.  
• Provide quality oversight of third parties, vendors, and service providers, including governance of quality agreements and performance monitoring.  
• Lead and oversee investigations of significant quality events (e.g., deviations, complaints, recalls), ensuring timely escalation, root-cause analysis, and sustainable corrective actions.  
• Drive a strong quality culture, reinforcing accountability, risk awareness, and continuous improvement.## Patient Safety & Pharmacovigilance
• Serve as the affiliate safety leader, accountable for the effective operation and oversight of pharmacovigilance systems and processes.  
• Ensure timely, accurate, and compliant reporting of adverse events, product complaints, and safety information in alignment with global standards and Canadian requirements.  
• Provide leadership oversight for signal management, safety risk assessment, and benefit–risk evaluation activities relevant to the local market.  
• Represent the affiliate in safety-related inspections, audits, and inquiries, ensuring credible engagement and high-quality outcomes.  
• Partner closely with Medical Affairs, Global Safety, and other stakeholders to ensure patient safety considerations are fully integrated into affiliate activities.## Controlled Substances & Product Security
• Act as Senior Person in Charge (SPIC) for controlled and special security substances.  
• Ensure effective governance, risk assessment, and procedural controls related to controlled substances and product diversion prevention, in alignment with corporate strategies and Canadian requirements.## Strategic Leadership & Cross-Functional Partnership
• Serve as a strategic advisor to the leadership team, providing risk-based quality and safety guidance that enables compliant business execution.  
• Represent the…