Eli Lilly and Company
Overview
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Sr. Manager - GMP Quality Logistics
role at
Eli Lilly and Company . 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 work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and support communities through philanthropy and volunteerism. We put people first and seek individuals determined to make life better for people around the world. This position will work out of Brownsburg, IN. Responsibilities
Provide leadership and oversight of Quality operations; directly manage quality functions and guide QA Representatives and Incoming Material Technicians. Advise on issues such as incoming material receipt, investigations, procedure creation and revision, with a focus on QA Warehouse operations. Oversee 3PL service provider within the Warehouse and support incoming material QA receipt and sampling using SAP and LIMS. Ensure compliance with GMPs, internal standards, systems, procedures, and guidelines for incoming material activities. Coordinate material receipt and sampling activities; supervise QA Representatives and QA Incoming Technicians at the warehouse. Lead, mentor, coach/develop, and support personnel; assess and triage deviations / CARTS in the warehouse. Collaborate with Lilly manufacturing sites to resolve material issues at the 3PL and ensure GMP waste processes are followed. Ensure materials not meeting specifications are quarantined per local procedures; evaluate damaged materials and determine acceptability with site representatives. Oversee GMP document management, generation of site metrics and reporting, and review/approve SOPs for the QA team and warehouse as needed. Oversee the training program for the QA team and support regulatory inspections as needed. Identify and resolve shipment issues (e.g., incorrect quantity, product, or contamination) and oversee the Complaints/Remarks process for the 3PL. Ensure proper temperature excursion assessment and Time Out of Refrigeration determinations for shipments. Ensure 3PL operations alignment with SOPs and regulatory requirements; participate in/support regulatory inspections. 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. Experience in GMP production and warehouse environments. Experience in inventory management systems (EWM, SAP, etc.). Ability to work 8-hour days (Mon–Fri) with overtime as required. On-site role located in Brownsburg, IN; some travel (0–20%). Previous facility or area start-up experience. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce and provides equal opportunities. If you require accommodation to submit a resume, please complete the accommodation request form at Lilly Careers. Our employee resource groups (ERGs) support networks for all employees. See list of groups on the Lilly site. Lilly is an EEO Employer and does not discriminate on the basis of protected characteristics or status. Actual compensation will depend on education, experience, skills, and location. The anticipated wage for this position may be disclosed during the interview process. Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs at its discretion.
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Join to apply for the
Sr. Manager - GMP Quality Logistics
role at
Eli Lilly and Company . 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 work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and support communities through philanthropy and volunteerism. We put people first and seek individuals determined to make life better for people around the world. This position will work out of Brownsburg, IN. Responsibilities
Provide leadership and oversight of Quality operations; directly manage quality functions and guide QA Representatives and Incoming Material Technicians. Advise on issues such as incoming material receipt, investigations, procedure creation and revision, with a focus on QA Warehouse operations. Oversee 3PL service provider within the Warehouse and support incoming material QA receipt and sampling using SAP and LIMS. Ensure compliance with GMPs, internal standards, systems, procedures, and guidelines for incoming material activities. Coordinate material receipt and sampling activities; supervise QA Representatives and QA Incoming Technicians at the warehouse. Lead, mentor, coach/develop, and support personnel; assess and triage deviations / CARTS in the warehouse. Collaborate with Lilly manufacturing sites to resolve material issues at the 3PL and ensure GMP waste processes are followed. Ensure materials not meeting specifications are quarantined per local procedures; evaluate damaged materials and determine acceptability with site representatives. Oversee GMP document management, generation of site metrics and reporting, and review/approve SOPs for the QA team and warehouse as needed. Oversee the training program for the QA team and support regulatory inspections as needed. Identify and resolve shipment issues (e.g., incorrect quantity, product, or contamination) and oversee the Complaints/Remarks process for the 3PL. Ensure proper temperature excursion assessment and Time Out of Refrigeration determinations for shipments. Ensure 3PL operations alignment with SOPs and regulatory requirements; participate in/support regulatory inspections. 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. Experience in GMP production and warehouse environments. Experience in inventory management systems (EWM, SAP, etc.). Ability to work 8-hour days (Mon–Fri) with overtime as required. On-site role located in Brownsburg, IN; some travel (0–20%). Previous facility or area start-up experience. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce and provides equal opportunities. If you require accommodation to submit a resume, please complete the accommodation request form at Lilly Careers. Our employee resource groups (ERGs) support networks for all employees. See list of groups on the Lilly site. Lilly is an EEO Employer and does not discriminate on the basis of protected characteristics or status. Actual compensation will depend on education, experience, skills, and location. The anticipated wage for this position may be disclosed during the interview process. Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs at its discretion.
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