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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 39,000 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’re looking for people who are determined to make life better for people around the world.
The Quality Assurance (QA) Scientist will provide quality oversight to assure that the development, commercialization and post-launch monitoring of diagnostics and companion diagnostics for Lilly drug therapies are compliant to applicable regulations and standards. The position will also provide general quality support as needed to Lilly Clinical Diagnostics Laboratory.
Provide leadership on the strategic design, implementation of effective Quality Systems at a corporate and local level to ensure harmonized practices across the global diagnostics network.
Lead teams in identifying gaps in current diagnostics quality system governance
Identify and lead the development of governing documents for diagnostics activities
Assist sites and product/project teams in developing plans for implementation of diagnostics network governing documents
Provide quality system consultation product/project and process teams
Lead /participate in the design, implementation, effective use and maintenance of electronic tools (e.g. Design Controls, CAPA, Risk Management, Production, Supplier Quality Management, and Documentation Management solutions) to support diagnostics quality systems
Provide quality support for diagnostics Alliance Partners and internal laboratories that diagnostic products and test methods to support Lilly clinical trials.
Implement and maintain effectiveness of Alliance Partners Lifecycle Management Process
Provides quality support in the identification, selection and qualification of Alliance Partners and Suppliers
Represent Lilly Quality on Diagnostic development teams.
Facilitate communication of Quality issues between Alliance Partners and Suppliers and Eli Lilly and Company Quality organization.
Serve as liaison to Alliance Partner and Supplier quality department(s).
Develop Quality Agreement(s) governing Alliance partnerships and facilitate review with Alliance partner and Lilly stakeholders
Develop and implement Quality System Oversight Document(s) for Alliance development partnerships.
Review and approve key milestone development documents for IVD development projects.
Facilitate communication of patient safety risk assessments between Lilly and Alliance Partners and Suppliers
Support the Lilly Clinical Diagnostics Laboratory during audits and external inspections as needed.
Provide quality review and approval of Clinical Diagnostics Laboratory documents as needed.
Bachelor's Degree in engineering or life science preferred
7 + years of experience in a quality management role in medical device industry
3+ years of design control experience of diagnostics product
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position
Demonstrated leadership/influencing skill in highly matrix organization
Demonstrated oral, written, and interpersonal communication, and project management skills
Knowledge of Molecular and Immunohistochemistry Pathology
Knowledge of clinical laboratory accreditation requirements, e.g., CLIA, ISO 15189
Regulatory submission experience
Third Party/Alliance Quality Management
Lilly is an EEO/Affirmative Action Employer and 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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