Sr. Associate/Principal – NALO QA - Distribution

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Organization Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Main Purpose and Objectives of Position:

The Associate – NALO QA - Distribution provides quality oversight of the distribution of commercial material at NALO and associated Third-Party Logistics (3PL’s) to ensure compliance with all GMPs, GDPs, internal standards, procedures, and guidelines. This includes oversight responsibilities related to both internal and external distribution partners and distribution-related GMP Service Providers (SP) used within NALO to ensure quality and timely delivery of material to patients.

Key Responsibilities:

• Make quality culture the foundation of your work, to ensure our products are delivered on time and in 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 centers 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 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 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 task and responsibilities
  • Collaborate with other functions, including hands-on work experience and shared learning
  • Propose solution and Benchmarking with other Lilly sites to gain support

Basic Requirements:               

• Bachelor’s degree in Pharmacy, Chemistry, Life Sciences, Engineering, or Supply Chain/Logistics. Work related experience may be substituted.
• 3+ years of pharmaceutical distribution experience in a QA role
• Prior QA experience working with Distribution, Medical Devices and providing oversight to 3rd Party Logistics and Service Providers.

Additional Skills:

• Knowledge and experience with CSQA and Quality Risk Management.
• Effective communication both written and oral
• 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