Lilly Device Quality Assurance Scientist in Indianapolis, Indiana

33028BR

Title Device Quality Assurance Scientist

City Indianapolis

State / Province Indiana

Country USA

Company Overview 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.

Responsibilities 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.

Key Objectives/Deliverables:

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.

Basic Qualifications

  • 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

Additional Skills/Preferences

  • 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

Additional Information 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.

Removal Date 18-Aug-2017