Job Description

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 35,000 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\xe2\x80\x99re looking for people who are determined to make life better for people around the world.

As a member of the Quality Team at Lilly Canada, the Quality Assurance role is to provide assurance, through independent assessment, consulting and educating, that Eli Lilly Canada Inc. and its local and global business partners who conduct GxP (Good Manufacturing Practices GMP, Good Pharmacovigilance Practices GVP, Good Distribution Practices GDP) activities as well as Medical Device activities on Lilly Canada\xe2\x80\x99s behalf, are in compliance with Canadian regulatory expectations and our Lilly Global Quality Standards. Key deliverables and accountability activities include:

• Quality Management Oversight through continuous monitoring of regulated processes, practices and documentation at Eli Lilly Canada and the partners that support our work to discover and bring life-changing medicines to people who need them.
• Lead both internal and external inspections supporting regulatory agency requests and collaboration partners
• Management and maintenance of the Eli Lilly Canada Inc. Establishment Licenses
• Quality oversight for GMP, Regulatory, and Patient Safety as appropriate and acts as consultant for identified areas of non-compliance and identifies and communicates to management business risks and root causes of quality issues with recommendations for remediation
• Collaborates with New Business Development for new business agreements
• Provides technical and compliance assistance for cross functional teams to support product changes and new initiatives
• Actively shares technical knowledge know-how and best practices
• Works with business owners to ensure quality management of Third Party and Lilly Affiliate Quality Agreements
• Keeps up to date on changes in Health Canada regulations, policies and guidances, internal Quality Standards, accesses impact on the business operations and assists in the communication and implementation of the required changes
• Ensures a Quality Plan is developed, approved, and maintained for areas of compliance risk
• Manages and coordinates the establishment of local Quality Systems
• Develops and monitors compliance performance measurements
• Authors quality related documents (SOPs including training courses) as appropriate
• Acts as Canadian expert in communications and interpretation of Canadian and Corporate requirements
• Interact with Health Canada and industry groups to influence local regulations, guidelines, and industry practices
• Prepare and deliver GxP training and provide technical guidance to Canadian business through the interpretation of global quality standards and guidelines to ensure patient safety and customer satisfaction

Education and Training

• University Degree in a relevant scientific field plus 4 to 5 years related experience in Quality Control / Quality Assurance role

Experience

• Minimum of 1 to 2 years Quality Assurance , auditing experience a asset

Skills

• Strong interpersonal and communication skills (both written and verbal), strong organizational and project management skills, strong negotiation skills, team player, detail-oriented with a thorough knowledge of the Food and Drugs Act, Food and Drug Regulations and related regulations (Good Manufacturing Practices)
• Strong communication skills, both verbal and written
• Strong knowledge of quality systems
• Demonstrated ability to manage large global organizations
• Project management experience

All new employees are required to be fully vaccinated against COVID-19 as a condition of being hired by Lilly as described in the attached Covid-19 Vaccination Policy.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively \xe2\x80\x9cLilly\xe2\x80\x9d) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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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