Lilly Sr Director – Parenteral Operations in Concord, North Carolina
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 35,000 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.
The Parenteral Operations Director is responsible to provide leadership to Parenteral Operations and cross functional leadership to the Parenteral Flow Team for the Lilly Concord site. The Operations Director will establish the operational organization and readiness agenda in alignment with the business and strategic plan. The Operations Sr Director is a key member of the Concord Site Lead Team ensuring safety, quality, and operational excellence.
Provide Health, Safety and Environmental (HSE) and Quality leadership for the Parenteral operational and flow team.
Support Site Leadership to build a diverse and capable site organization based in engineering first principles and operational excellence. Talent management, development, and retention within the Concord organization (and beyond).
Provide operational technical leadership and develop objectives to deliver Business and Strategic Plan Goals as it relates to safety, quality, and equipment/process effectiveness and efficiency.
Represent operational capabilities beyond the Lilly Concord site (e.g. other Lilly sites and global functional groups).
Partner with Technical Services, Quality and Engineering leadership to deliver operational results.
Actively engage team and deliver significant capital and technological projects.
Deliver equipment, lines, and supporting systems through user requirements, design, build, verification, qualification, validation, and subsequent operation.
Develop local processes and procedures for the operational function.
Ensure practice matches procedure.
Ensure the functions are aligned and driven to meet production throughput goals including daily operation of the manufacturing lines, deviation and change management, variability reduction, and equipment/system reliability.
Champion continuous improvement.
Develop and maintain metrics to measure performance against business objectives and make necessary changes to improve performance.
Participate in the development and implementation of strategies associated with the area sponsoring or supporting the following initiatives: Continuous Improvement, Root Cause Analysis (RCA), and Failure Modes Effect Analysis (FMEA).
This role has direct interaction with Regulatory Agencies during site inspections.
Understand and influence the manufacturing control strategy for parenteral formulation and filling
Bachelor's Degree in Engineering, a Life Science, or Business/Operations
At least 10 years of experience at a manufacturing site
At least 5 years previous management or leadership experience including leading or working effectively with a cross functional group
Front line experience in parenteral drug product operations
Solid understanding of basic requirements of regulatory agencies
Previous facility or area start up experience
Previous experience in operations and engineering
Previous experience with highly automated equipment
Previous experience with combination products, device assembly, pharmaceutical packaging, drug product formulation and filling in aseptic environment
Previous equipment qualification and process validation experience
Previous experience with Manufacturing Execution Systems and electronic batch release.
Previous experience with Automated Storage and Retrieval System (ASRS) Warehouses or AGVs
Previous experience with deviation and change management systems including Trackwise
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