Sr. Director - Patient Safety and Quality
Eli Lilly and Company
Job Overview
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Job Description
Overview
At Lilly, we unite caring with discovery to make life better for people globally. As a global healthcare leader, our mission is to deliver life-changing medicines, enhance disease management, and give back to our communities. We are seeking a Sr. Director - Patient Safety and Quality to lead quality assurance and pharmacovigilance with strong patient safety focus.
Key Responsibilities
Quality Leadership: Oversee GxP quality across importation, distribution, commercialization, and sampling. Enhance and maintain the Quality Management System (QMS) including CAPA effectiveness, deviation management, change control, and inspection readiness. Provide quality oversight for third parties and manage investigations of deviations, complaints, and recalls.
Patient Safety & Pharmacovigilance: Lead pharmacovigilance systems ensuring timely and compliant safety reporting and adverse event management. Oversee signal management and benefit–risk evaluation and represent the affiliate in safety inspections and audits.
Controlled Substances & Product Security: Manage controlled substances as the Senior Person in Charge and enforce risk assessment and controls for product security.
Strategic Leadership & Cross-Functional Partnership: Advise leadership on quality and safety, partner with global teams and cross-functional stakeholders, and drive continuous improvement using performance metrics and audits.
People Leadership: Lead and develop a high-performing Quality & Safety organization, ensuring engagement, accountability, and professional development.
Qualifications
Advanced degree in life sciences, pharmacy, or related field (Master’s, PharmD, or PhD preferred) with 10+ years of progressive leadership experience in the pharmaceutical or life sciences industry. Experience in managing inspections, audits, recalls, and complex quality/safety issues, with deep knowledge of GMP, GDP, and quality management frameworks.
Additional Information
This is a hybrid role with an onsite presence at our Toronto office at least 10 days per month. Additional compensation, bonus eligibility, and a comprehensive benefits program are offered.
Key skills/competency
- Quality Assurance
- Pharmacovigilance
- Compliance
- Inspection Readiness
- Risk Management
- Leadership
- Continuous Improvement
- Cross-functional Collaboration
- GMP
- Strategic Planning
How to Get Hired at Eli Lilly and Company
- Customize your resume: Highlight quality leadership and safety experience.
- Showcase compliance: Emphasize GMP, GDP, and audit expertise.
- Network strategically: Connect via LinkedIn and company events.
- Prepare for interviews: Practice situational and technical questions.
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