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.

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 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.

Qualifications

• 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.

Additional Requirements

• 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.