Eli Lilly and Company
Associate Director - Operations
Eli Lilly and Company, Concord, North Carolina, United States, 28027
Overview
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Associate Director - Operations
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 give back to our communities through philanthropy and volunteerism. We’re looking for people who are determined to make life better for people around the world.
Position is within the Device and Packaging Network and focuses on leading manufacturing operations, executing strategies and objectives, and fostering a culture of innovation and excellence. This role will collaborate with cross-functional leaders to drive organizational priorities, quality objectives, and floor-level performance.
Key Objectives / Deliverables
Empowerment through Development: Mentor, coach, and recognize team members to foster growth and meet business needs.
Strategic Planning: Engage with business plan objectives, track performance, and ensure resources are in place for successful implementation.
Safety and Quality Culture: Lead by example in safety and quality; review and approve GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols, and summary reports.
Technical Excellence: Provide technical input and process support for manufacturing issue resolution and investigations; champion continuous improvement initiatives.
Process Optimization: Develop local processes and procedures to enhance efficiency using lean tools.
Resource Management: Manage resources, workload, and staffing to meet objectives; support site leadership in building a diverse and capable organization for device assembly and packaging.
Collaborative Leadership: Work with cross-functional teams, external partners, central functions, and suppliers; represent the team on plant flow teams and drive operational results.
Performance Metrics: Develop and communicate department metrics; set safety, quality, and process efficiency goals; lead the process team for issue resolution.
Innovation and Problem-Solving: Foster a culture of innovation and drive improvement opportunities.
Regulatory Compliance: Ensure adherence to regulatory requirements (cGMP, OSHA, environmental goals); support inspection readiness; interact with Regulatory Agencies during site inspections.
Minimum Requirements
Bachelor's Degree in Engineering, Science, or a related field.
5+ years of manufacturing experience in pharmaceutical or regulated industry.
3+ years of demonstrated leadership with a record of team development.
Additional Preferences And Information
Experience in device assembly and/or packaging.
Knowledge of cGMP requirements in medical device manufacturing.
Understanding of regulatory agency requirements (FDA, DEKRA, OSHA).
Excellent interpersonal, written, and oral communication skills for decisions, influencing, coaching, and mentoring.
Occasional travel may be required.
Personal protective equipment is required on the manufacturing floor.
Experience with deviation and change management systems (e.g., Trackwise).
Maintaining a safe work environment and supporting health, safety, and environmental goals.
Lilly is an EEO employer and provides accommodation in the application process upon request. Actual compensation depends on education, experience, skills, and location. Lilly reserves the right to amend compensation and benefits programs at its discretion.
Location:
Charlotte, NC
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Associate Director - Operations
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 give back to our communities through philanthropy and volunteerism. We’re looking for people who are determined to make life better for people around the world.
Position is within the Device and Packaging Network and focuses on leading manufacturing operations, executing strategies and objectives, and fostering a culture of innovation and excellence. This role will collaborate with cross-functional leaders to drive organizational priorities, quality objectives, and floor-level performance.
Key Objectives / Deliverables
Empowerment through Development: Mentor, coach, and recognize team members to foster growth and meet business needs.
Strategic Planning: Engage with business plan objectives, track performance, and ensure resources are in place for successful implementation.
Safety and Quality Culture: Lead by example in safety and quality; review and approve GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols, and summary reports.
Technical Excellence: Provide technical input and process support for manufacturing issue resolution and investigations; champion continuous improvement initiatives.
Process Optimization: Develop local processes and procedures to enhance efficiency using lean tools.
Resource Management: Manage resources, workload, and staffing to meet objectives; support site leadership in building a diverse and capable organization for device assembly and packaging.
Collaborative Leadership: Work with cross-functional teams, external partners, central functions, and suppliers; represent the team on plant flow teams and drive operational results.
Performance Metrics: Develop and communicate department metrics; set safety, quality, and process efficiency goals; lead the process team for issue resolution.
Innovation and Problem-Solving: Foster a culture of innovation and drive improvement opportunities.
Regulatory Compliance: Ensure adherence to regulatory requirements (cGMP, OSHA, environmental goals); support inspection readiness; interact with Regulatory Agencies during site inspections.
Minimum Requirements
Bachelor's Degree in Engineering, Science, or a related field.
5+ years of manufacturing experience in pharmaceutical or regulated industry.
3+ years of demonstrated leadership with a record of team development.
Additional Preferences And Information
Experience in device assembly and/or packaging.
Knowledge of cGMP requirements in medical device manufacturing.
Understanding of regulatory agency requirements (FDA, DEKRA, OSHA).
Excellent interpersonal, written, and oral communication skills for decisions, influencing, coaching, and mentoring.
Occasional travel may be required.
Personal protective equipment is required on the manufacturing floor.
Experience with deviation and change management systems (e.g., Trackwise).
Maintaining a safe work environment and supporting health, safety, and environmental goals.
Lilly is an EEO employer and provides accommodation in the application process upon request. Actual compensation depends on education, experience, skills, and location. Lilly reserves the right to amend compensation and benefits programs at its discretion.
Location:
Charlotte, NC
#J-18808-Ljbffr