Sr. Associate – QA Distribution

Role Summary

Sr. Associate – QA Distribution provides quality oversight of the distribution of commercial material at Lilly's North American Logistic Operations (NALO) and associated third‑party logistics providers to ensure compliance with GMPs, GDPs, internal standards and guidelines. This role covers oversight of both internal and external distribution partners and distribution-related GMP service providers to ensure quality and timely delivery of material to patients.

• 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 integrity leader to ensure a robust Quality System and computer systems in full compliance with regulations and data integrity requirements.
• Understand NALO operations to provide quality oversight, identify and escalate potential quality concerns, support meeting business goals, and lead process improvement initiatives.
• Support engineering and provide Quality oversight to FUME activities and projects.
• Provide quality oversight for the 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 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 and 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 suppliers and service providers per Supplier Quality Management System.
• Manage, investigate and document product and distribution complaints and monitor performance.
• Author, review and approve quality documents such as deviation investigations, change control activities, CARTS, PPE, SCNs and SOPs, with focus on issue resolution and continuous improvement.
• Develop and collect metrics related to the Quality performance within the area of responsibilities; provide updates to management and propose performance improvement.
• Support inspection readiness initiatives and internal/external audits (site self‑inspections; regulatory agencies and GQAAC).
• Support the Operations by: timely and accurately completing all assigned tasks, collaborating with other functions, and benchmarking with other Lilly sites to gain support.
• Other duties as assigned.

• Required: Bachelor’s degree in Engineering, Pharmacy, Chemistry, Life Sciences, Supply Chain/Logistics, or related field.
• Required: 3+ years of engineering and/or QA experience supporting distribution in the pharmaceutical industry.
• Required: Authorized to work in the United States on a full‑time basis (no sponsorship).
• Preferred: Prior quality or engineering experience in distribution, medical devices, and oversight of 3PLs and service providers.
• Preferred: Prior FUME experience and understanding of FUME requirements and regulations.
• Preferred: Knowledge and experience with CSQA and data integrity applications.
• Preferred: Experience with ICH Q9 and Lilly’s Quality Risk Management standards.
• Preferred: Clear understanding of GMP/GDPs, policies, procedures, regulations and guidelines related to commercial distribution.
• Preferred: Knowledge and experience in quality records (Deviation, CC, PPE, SCN’s, procedures, etc.).
• Preferred: Effective written and verbal communication; ability to work independently and manage time and projects; strong prioritization and problem‑solving skills.
• Preferred: Strategic thinking with ability to influence diverse groups and communicate at all levels of an organization internally and externally.

• This is an on-site dayshift position, with occasional after‑hour work expected to support operation.
• Travel: 25-30% to regional distribution centers under NALO Quality oversight.