Lead Specialist, Qa

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.

About POINT Biopharma:

POINT Biopharma Global Inc. is a globally focused radiopharmaceutical company building a platform for the clinical development and commercialization of radioligands that fight cancer. Recently acquired by Eli Lilly and Company, POINT aims to transform precision oncology by combining a portfolio of targeted radioligand assets, a seasoned management team, an industry-leading pipeline, in-house manufacturing capabilities, and secured supply for medical isotopes including actinium-225 and lutetium-177. POINT is a wholly owned subsidiary of Eli Lilly and Company.

Position Summary:

Reporting into the Manager of Quality Assurance the Quality Assurance Lead Specialist will be responsible for:

• Supporting the organization with continued compliance and monitoring conformance to established internal procedures and regulatory standards.
• Batch record review and final batch release.
• Supplier audits and qualification.
• Managing quality events and the associated investigations at the site.

Roles and Responsibilities of the Position:

• Reviewing batch records, product specifications, Certificates of Analysis and all other supporting documentation related to the release of product.
• Involved in vendor qualification.
• Support and participate with internal/external audits.
• Maintain Change Control system.
• Initiate CAPAs and Change Controls as applicable.
• Manage notification to stakeholders and timely completion of Key Performance Indicators (KPI)
• Review and evaluate compendia monograph updates and regulatory guidance updates.
• Participate as member of site deviation investigation teams.
• Write and assist others in writing Standard Operating Procedures (SOPs) and manage the approved SOPs.
• Participate in
• Issue documents and logbooks as required.
• Initiate Vendor Quality Agreements
• Manage site training program.
• Assist in Annual GMP Training.
• May perform other related additional duties as assigned.

Required Qualifications:

• Bachelor’s degree
• 2-5 years of experience in a GMP or equivalent regulated environment
• Experience in vendor qualification and audit.
• Training and experience in documentation control, change control, CAPAs and review of quality records.
• Ability to work independently and possess excellent organizational skills.

Additional Preferences:

• B.Sc in the life sciences degree; including pharmacy, chemistry or other equivalent qualification if preferred
• Understanding of Health Canada, FDA and EU GMP regulations, with specific knowledge of the regulations as they pertain to sterile products preferred.

Physical Demands/Travel:

• Not applicable

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment:

• Position is onsite during the work week located Toronto downtown at UHN near College Street and University Avenue.
• This role works in a hospital setting and it is mandatory for all employees to complete health screens before onboarding. In the event the screen results show non-immunity, vaccines may need to be administered.

Theworkenvironmentcharacteristicsdescribedherearerepresentative of those an employee encounters while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Eli Lilly Canada is committed to employment equity. We encourage applications from qualified women, members of visible minorities, aboriginal peoples, and persons with disabilities.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) 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.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) 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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