Quality Assurance - NALO - Distribution

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 Devices and providing oversight to 3PLs and Service Providers
• Prior FUME experience and understanding FUME requirements and regulations
• Knowledge and experience with CSQA and Data Integrity application
• Experience with ICH Q9 and/or Lilly's Quality Risk Management standards
• Clear understanding of all GMP/GDPs, policies, procedures, regulations and guidelines related to commercial distribution
• Knowledge and experience in quality records (Deviation, CC, PPE, SCN's, procedure, etc.)
• Effective communication, both written and oral
• Demonstrated ability to be self-driven, work independently, and apply time management and project management skills
• High-quality skills to include ability to prioritize, critical decision making, interpersonal/people, problem solving
• Strategic thinking and ability to influence diverse groups and communicate effectively to all levels of an organization internally and externally
• Strive to exceed individual and business goals and continuous improvement

Additional Information

This is an on-site, dayshift position, with occasional off-hours, weekend, and holiday support may be needed, including during Summer Shutdown, year-end, and the Christmas-New Year period. Position Location: Plainfield Distribution Center, Plainfield, Indiana. Travel: 25-30% travel to regional distribution centers under NALO Quality oversight.