Sr. Manager

Found in: beBee S US - 3 weeks ago

Concord, United States Eli Lilly and Company Full time

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.

Position Description:

Lilly is building a new state of the art Parenteral, Device Assembly, and Packaging Facility in Concord, North Carolina.  This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up. 

The Lilly Concord warehouse is a fully automated warehouse system with automated pallet conveyors, pallet exchangers, ASRS (Automated storage and retrieval system), and AGV (Autonomous Guided Vehicle) delivery of materials to the line.  The Quality Assurance Manager for the Warehouse team managers and develops, provides assistance and guidance to the incoming QA, warehouse QA, and incoming disposition teams. This role reports directly to the Associate Director – Materials Quality.  The Quality Assurance Warehouse Manager position is essential for maintaining GMP compliance and providing support during preparation for Pre-Approval/General Inspections by various regulatory agencies.   

Responsibilities:

Practices safety behaviors with proper PPE and lifting techniques. Supports all HSE Corporate and Site Goals.Manage a team of QA Incoming, QA Warehouse, and QA Incoming Batch Disposition associates.Support QA incoming functions at multiple warehouse locations.Responsible for training and managing teams with regards to:Performing incoming inspections (raw materials, components, printed packaging materials, etc.) according to priority.Documenting inspections in accordance with procedures and specifications.Ensuring materials not meeting specifications are quarantined, per local procedures.Sampling, inspecting, and documenting results utilizing electronic systems (Darwin, SmartLab, etc).When sampling a portion of the batch, ensure proper sampling plan is followed.Working with the QC Lab to deliver samples and receive resultsPerforming ID testing of materials utilizing Raman or NIR Spectroscopy. Maintaining retains and samples per local procedures.Evaluating damaged materials found on inbound shipments or within the warehouse and determine acceptability.  Ensuring storage condition is tracked, accurate, adjusted (as needed) including evaluating temperature excursions on shipments received at the warehouse.Assists in resolving issues on inbound shipments (i.e.incorrect quantity or product, contamination, etc.). Performs appropriate transactions in SAP to ensure system represents appropriate status of material (QI, blocked, scrapped, etc.)Disposition of incoming raw materialsProvide Quality support to warehouse with regard to deviations and other non-conformance issuesMay need to assist with performing department activities to ensure materials are available for production.Responsible for ensuring team is trained and training remains in compliance.Communicates with QA Associate Director Materials and other cross functional peers on quality issues.Lead, mentor, and coach QA, Warehouse, and support personnel on quality matters, while supporting and driving the site Quality culture.Ensure regular presence in operational areas to monitor GMP programs and quality systems.Work with materials management QA group to initiate complaints/remarks to supplier for materials not meeting Lilly expectations.May participate in investigations regarding materials or service complaints.Networks with the business and ensures all materials are dispositioned in a timely manner to support production schedule.Authors/revises SOPs, materials specifications, as needed.Supports material related Supplier Change Notification's (SCN).Participates in/supports regulatory inspections, as needed.

Basic Requirements (Education, Experience, Training):

Bachelor’s Degree

Additional Prefences:

Previous materials or warehouse experience.Previous Quality Assurance experience.Previous experience leading and managing a team.Demonstrated understanding of cGMP regulations related to QA Inspection applications.Strong attention to detail.Proficient in computer system applications.Ability to organize and prioritize multiple tasks, highly flexible and able to work independently in fast paced environment to support production demands.Excellent interpersonal and networking skills.Highly motivated, enthusiastic, share ideas and lead solutions effectively to resolution; ensure safety of others.Understanding of statistical tools and analysis.Experience in inventory management systems (SAP, etc.)Previous experience in GMP production environments.Previous facility or area start up experience.
 

Additional Information:

The position is for the Lilly Concord site and will support a 24/7 operationAbility to support off-shift requestsAbility to work 8 hour days – Monday through Friday. Ability to work overtime as required. 

This job specification is intended to provide a general overview of the job requirements at the time it was prepared.  The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job specification.  As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position. 

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

#WeAreLilly

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