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.

Senior Director, Quality, Safety & Regulatory Affairs

Position Purpose

The Senior Director, Quality, Safety & Regulatory Affairs is a strategic leadership role responsible for ensuring the highest standards of product quality, patient safety, and regulatory compliance for the Canadian affiliate. This leader oversees Quality Assurance/Control, Regulatory Affairs, and Safety/Complaints functions, and partners cross-functionally to ensure sustainable compliance, inspection readiness, and patient trust.

The role requires visionary leadership to shape local quality and safety strategies, drive operational excellence, influence global initiatives, and ensure adherence to Health Canada regulations and corporate policies.

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.

Key Responsibilities

Quality Leadership

• Serve as Site Quality Leader / Product Quality Representative, ensuring GxP quality processes across importation, distribution, commercialization, and sampling programs meet Health Canada and global standards.
• Oversee and continuously improve the affiliate’s Quality Management System (QMS), ensuring risk-based controls, data integrity, deviation management, CAPA effectiveness, and audit readiness.
• Lead quality oversight of third parties, vendors, and service providers, ensuring quality agreements and performance monitoring are in place.
• Drive quality culture, embedding GMP compliance, ownership, and proactive risk management across the affiliate.
• Lead investigations of critical quality events, including recalls, deviations, and product complaints, ensuring timely reporting and root cause resolution.

Regulatory Affairs

• Provide strategic direction on regulatory strategy for new product submissions, lifecycle management, labeling, and promotional materials.
• Ensure all regulatory filings and Health Products and Food Branch (HPFB) registrations are maintained for marketed and investigational products.
• Act as primary affiliate liaison with Health Canada for regulatory interactions and inspections, ensuring transparent and credible engagement.
• Partner with clinical development teams to ensure regulatory support of clinical trial applications (CTAs) and Good Clinical Practice (GCP) compliance.

Safety & Pharmacovigilance

• Ensure timely and accurate reporting of adverse events, product complaints, and safety signals in accordance with Canadian and global requirements.
• Provide governance and oversight of pharmacovigilance activities to ensure patient safety is never compromised.
• Maintain a state of inspection readiness and serve as the affiliate representative for safety-related audits and inquiries.

Controlled Substances & Security

• Serve as Senior Person in Charge (SPIC) for controlled and special security substances, ensuring compliance with Health Canada regulations and Lilly’s Global Product Diversion Control Strategy.
• Oversee security controls, risk assessments, and procedural compliance related to controlled substances.

Strategic Leadership & People Management

• Lead and develop a high-performing multidisciplinary team (Quality, Regulatory, Safety), ensuring strong technical expertise, decision-making accountability, and career growth.
• Represent the affiliate in global/regional forums to influence policy, share best practices, and drive alignment on quality, regulatory, and safety matters.
• Partner cross-functionally (Medical, Commercial, Supply Chain, Legal, Corporate Affairs) to support business objectives without compromising compliance or patient safety.
• Champion a culture of continuous improvement, leveraging metrics, audits, and feedback to enhance systems and processes.

Qualifications

• Education: Advanced degree in life sciences, pharmacy, or related field (Master’s/PharmD/PhD preferred).
• Experience: 10+ years in the pharmaceutical industry with progressive leadership experience in Quality, Regulatory Affairs, and Safety.
• Proven track record of managing regulatory agency inspections, product recalls, and compliance programs.
• Strong understanding of Health Canada regulations, GMP, GCP, GDP, and pharmacovigilance frameworks.
• Experience influencing global teams and contributing to enterprise-level decision-making.

Leadership Competencies

• Strategic thinker with enterprise mindset; ability to balance risk and business priorities.
• Exceptional communicator who can engage regulators, global stakeholders, and internal leadership with credibility.
• Strong leader-coach with proven ability to inspire, develop, and retain top talent.
• Demonstrated ability to foster collaboration across functions and geographies.
• Resilient, decisive, and adaptable to a rapidly changing regulatory and business environment.

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 (https://careers.lilly.com/us/en/workplace-accommodation) 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.

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