Sr. Manager - Logistics Quality

Job Opportunity At Lilly

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.

Responsibilities : The Sr. Manager Logistics Quality will report to the Associate Director Regional Logistics Operations QA. The Senior Manager Logistics Quality provides leadership and oversight of Quality operations, directly manages quality functions, provides assistance, and guidance to QA Representatives and Incoming Material Technicians and will advise on issues such as incoming material receipt, investigations, procedure creation and revision, with a focus on QA Warehouse operations. This person will also oversee 3PL (Third Party Logistics) service provider within the Warehouse. Their team will support incoming material QA receipt and sampling utilizing SAP and LIMS. The Senior Manager is responsible for ensuring compliance with all GMPs, internal standards and systems, procedures, and guidelines for incoming material activities. This Position will work out of Brownsburg, IN.

Key Objectives / Deliverables : Practices safe behaviors within a warehouse environment with proper PPE and lifting techniques. Coordinate material receipt and sampling activities. Responsible for managing QA Representatives and QA Incoming Technicians at the warehouse. Lead, mentor, coach / develop, and support personnel. Ability to assess and triage deviations / CARTS that occur within the warehouse area. Work with Lilly manufacturing sites to resolve or provide advice on material issues at the 3PL. Be responsible for 3PL operations at the warehouse, ensure GEMBA and oversight activities are performed ensuring compliance with SOPs and Regulations. Ensuring materials not meeting specifications are quarantined, per local procedures. Evaluating damaged materials found on inbound shipments or within the warehouse and collaborate with Lilly manufacturing sites representatives to determine acceptability. Oversee the GMP Waste process for materials located at the warehouse. Supervise the management, reconciliation, and retention of GMP documents. Generation of site metrics and reporting. Evaluating temperature excursions and applying TOR (Time out of Refrigeration) on shipments received at the warehouse. Identifies and assists in resolving issues on shipments (i.e. Incorrect quantity or product, contamination, etc.). Oversees the Complaints / Remarks process for the 3PL. Reviews and Approves SOPs for the QA team and the Warehouse as needed. Oversees the training program for the QA team and ensures compliance. Participates in / supports regulatory inspections, as needed. Other duties as assigned.

Basic Qualifications : BA / BS degree Minimum of 5 years of GMP / Regulated industry experience (Preferably in Quality Assurance and Logistics)

Additional Skills / Preferences : Supervisory experience. Demonstrated understanding of cGMP regulations related to QA Warehouse and Inspection applications. Previous experience in GMP production and warehouse environments. Experience in inventory management systems (EWM, SAP, etc.) Ability to work 8-hour days Monday-Friday, Ability to work overtime as required. This role will be on-site and permanently located in Brownsburg, IN. Previous facility or area start-up experience. This role will require some travel 0-20%

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