Quality Assurance - NALO - Distribution

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. Every dose that reaches a patient has to arrive with its quality intact. In this role, you'll be the quality voice for our commercial distribution network, making sure our North American Logistic Operation's warehouses, third-party logistics (3PL) partners, and distribution service providers meet GMP, GDP, and Lilly quality standards. You'll work hands-on with quality records, risk assessments, and metrics, and you'll build deep technical expertise in how a regulated distribution network runs. Responsibilities Make quality culture the foundation of your work, to ensure our products are delivered on time and in a safe and effective manner to improve patients' lives. Collaborate with site compliance leader and site data leader to ensure robust Quality System and Computer System Validation to ensure compliance and meet data integrity requirements. Understand NALO Operations to be able to provide quality oversight, identify and escalate potential Quality concerns, support meeting business goals and lead process improvement initiatives. Provide Quality oversight for NALO distribution operations network and maintain a state of inspection readiness for all distribution warehouses under NALO control. Support development of quality indicators/metrics to track Quality performance at all distribution locations. Collaborate both internally and externally to identify opportunities to standardize operations, increase global harmonization, and identify improvement opportunities. Apply Quality Risk Management principles to NALO operations, using Lilly quality standards. Author, review, and approve Risk Assessments to ensure adequate oversight including external monitoring of regulatory changes. Provide quality oversight and maintain the qualified status of distribution supplier and service provider per Supplier Quality Management System. Manage, investigate and document product and distribution complaint and monitor performance. Author, review and approve quality documents such as deviation investigations, change control activities, CARTS, PPE, SCN's, SOP, etc., with focus on issue resolution and continuous improvement. Develop and collect metrics related to the Quality performance within area of responsibilities. Provide updates to management and propose performance improvement. Support inspection readiness initiative and internal/external audits (site self-inspections; regulatory agencies and GQAAC). Support the Operations by: Timely and accurately completing all assigned tasks and responsibilities Collaborating with other functions, including hands-on work experience and shared learning Proposing solutions and benchmarking with other Lilly sites to gain support Other duties as assigned. Basic Requirements Bachelor's degree in pharmacy, Chemistry, Life Sciences, Engineering, or Supply Chain/Logistics One plus years of experience in quality assurance, distribution, or supply chain within the pharmaceutical or medical device industry. Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1. Additional Preferences Prior Quality or Engineering experience working in Distribution, Medical Devi…

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