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

Additional information

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $66,000 - $171,600

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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