Sr. Director

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

• 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.

• 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.

• 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.

• Serve as a strategic advisor to the leadership team, providing risk-based quality and safety guidance that enables compliant business execution.
• Represent the affiliate in global and regional quality and safety forums, contributing to policy development, sharing best practices, and ensuring alignment with enterprise standards.
• Partner effectively with Medical, Commercial, Supply Chain, Legal, and Corporate Affairs to support business priorities without compromising quality or patient safety.
• Lead continuous improvement initiatives using metrics, inspections, audits, and performance insights to strengthen systems and capabilities.

• Lead, develop, and retain a high-performing Quality & Safety organization, fostering strong technical capability, decision-making confidence, and succession readiness.
• Build a culture of engagement, accountability, and professional development aligned with enterprise leadership expectations.

• Advanced degree in life sciences, pharmacy, or a related discipline (Master's, PharmD, or PhD preferred).
• 10+ years in the pharmaceutical or life sciences industry with progressive leadership experience in Quality and/or Pharmacovigilance.
• Demonstrated experience leading inspections, audits, recalls, and quality or safety-related issue management.
• Deep knowledge of GMP, GDP, pharmacovigilance systems, and quality management frameworks.
• Proven ability to influence global stakeholders and operate effectively within a matrixed organization.

• Enterprise mindset with the ability to balance patient safety, quality risk, and business objectives.
• Credible, confident communicator with senior leaders, global partners, and external stakeholders.
• Strong people leader and coach with a track record of building resilient, high-performing teams.
• Collaborative, decisive, and adaptable in complex and evolving environments.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Actual compensation will depend on a candidate's education, experience, skills, and geographic location.  The anticipated wage for this position is

Full-time equivalent employees may also be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a pension plan; vacation benefits; eligibility for healthcare benefits; flexible benefits (if applicable) life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.