Associate/Sr. Associate - QA Distribution/TEIC Oversight

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:

The Associate - QA provides quality oversight of the distribution of Clinical Trial materials ensuring compliance with all GMPs, GDPs, internal standards, procedures, and guidelines for distribution. This includes oversight responsibilities related to both internal and outsourced distribution operations to ensure quality and timely delivery of CT material to patients. The Associate – QA provides quality oversight of the Temperature Excursion Investigation Center (TEIC).

Responsibilities:

• Provide quality oversight for Clinical Trial material distribution operations in B401.

• Review/approval of deviation investigations, change control activities, SOP development, issue resolution and continuous improvement activities.

• Provide quality oversight of outsourced Clinical Trial material distribution operations within Zone 1 (North/South America) including deviation review/approval, issue resolution, and on-site visits, as required.

• Provide quality oversight of the sourcing and distribution of study-related non-drug supplies (ancillaries).

• Perform release activities for non-modified commercial products that are received into the distribution network for distribution to clinical sites.

• Provide quality oversight of the TEIC including assessment and approval of temperature excursion investigations

• Collaborate both internally and with collaboration partners to identify opportunities to standardize operations, increase global harmonization, and identify improvement opportunities.

• Provide updates to management regarding the Quality performance within areas of oversight. Collect metrics related to the Quality assessment of responsibilities.

• Support and provide quality oversight of distribution improvement projects.

• Develop quality indicators/metrics to be tracked by all distribution locations;

• Provide quality oversight and maintain the qualified status of distribution CPs;

• Identify, communicate, and lead resolution efforts for systemic Quality System gaps;

• Interact with regulatory agencies during inspections regarding cGMPs/cGDP issues;

• Lead and participate in internal/external audits (site self-inspections; regulatory agencies and GQAAC)

• Maintain necessary state licenses for K401 distribution activities.

• Serve as the liaison between Distribution CPs and internal Lilly Quality operations;

• Review and approve trends, observations, and change controls.

• Other duties as assigned.  

Basic Qualifications:       

• Bachelor’s degree in a science or business-related field (Pharmacy, Chemistry, Life Sciences, Engineering, Supply Chain/Logistics preferred)

• 2+ years of quality experience

Additional Preferences:

• Prior experience working in Distribution and Collaboration Partners.

• High-quality skills to include: ability to prioritize, interpersonal/people skills, problem solving

• Strong communication skills, both written and verbal, and ability to manage external partners;

• Self-motivation and ability to work independently and within teams.

• Clear understanding of all GMP/GDPs, policies, procedures, and guidelines related to distribution of IP material, Commercial material and ancillaries.

• Knowledge and experience in SAP, TW and and QDoc.

This role is located onsite in Indianapolis, IN with the ability to work from home 4 days per month and is not approved for remote work.

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