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.

The Quality Assurance Associate for Materials Management is responsible for the site parenteral & device materials management systems. The Materials Management associate provides Quality Oversight for the suppliers and materials utilized by the site. This position supports all Materials Management activities relative to the Site in order to ensure appropriate Quality Oversight.

Key Objectives/Deliverables: 

Work with site staff and global resources to establish site material suppliers for startupCoordinates the appropriate tasks to develop and maintain the approved supplier listConduct material and supplier risk assessments and periodic reviews of supplier performanceCoordinate and write Supplier, Service Provider, and Affiliate Quality Agreements, including networking with site resources to ensure compliance to associated requirementsProvide input, guidance and recommendation for Supplier/Service Provider approval and certification activitiesProvides support to the warehouse for incoming receipt, sampling and testingMaintain complaint database (track supplier responses for warehouse, incoming and operations complaints)Provide input and guidance to site activities (e.g., six sigma, new product/process development, change controls) as material quality SMEBe able to perform materials SAP data steward functionsReview and Redline Materials and other GMP documents, including specifications and procedures. Provide procedure ownership and subject matter expertise, as necessary.Provide the voice of quality to the Material Management Governance Committee and Supplier Certification Global Committee, providing input and support as needed in order to ensure complianceInitiate supplier complaints (CARTs) when issues ariseSupport regulatory inspection activities as needed by providing documentation and SME supportTrack and report materials management metrics to Supplier Relationship Meetings, supplier committees, and Materials Management Governance CommitteeLead, as required, local or global teams, committees, or other groups to resolve quality issues and ensure site compliance to Lilly Standards and external regulations

Minimum Requirements:

Bachelor's degree in a science, engineering, computer, or pharmaceutical related field of studyExperience working in the pharmaceutical or medical device industry in QA roles

Additional Preferences:

Previous facility or area start up experiencePrevious equipment qualification and process validation experiencePrevious experience with SAP or other inventory management systemsPrevious experience with device and parenteral product materialsCQA certification from the American Society for Quality (ASQ)Previous experience with deviation and change management systems including TrackwisePrevious materials management and supplier management experienceProficiency with material management computer systems and applications including Microsoft Office products, SAP, Regulus, Veeva QDocs and TrackWise or similar systemsPrevious regulatory inspection readiness and inspection execution experienceStrong oral and written communication and interpersonal skillsAbility to influence externally with suppliers and resources across sitesResponsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site GoalsStrong technical aptitude and ability to work with component and technical stewardsAbility to work 8-hour days – Monday through FridayAbility to work overtime as requiredAbility to travel up to 10% to Indianapolis, IN for meetings and coordination with global regulatory organizations.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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