Lilly
Associate Director - Operations - Device Assembly and Packaging
Lilly, Indianapolis, Indiana, us, 46262
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.
Are you ready to lead the charge in shaping the future of manufacturing at Eli Lilly? As an Associate Director of Operations, you'll be at the forefront of this exciting journey. In this role within our Device and Packaging Network, you'll not only execute strategies and objectives but also inspire a culture of innovation and excellence. Collaborating with our top-notch team of leaders, you'll influence and implement our organizational agenda, business priorities, and quality objectives to drive success down to the floor level.
Key Objectives/Deliverables:
Empowerment through Development:
Mentor, coach, and recognize team members within your organization to foster growth, achievement and meet the needs of the business.
Strategic Planning:
Engage and support business plan objectives while tracking team performance and ensuring adequate resources are in place for successful implementation.
Safety and Quality Culture:
Lead by example in building and driving a culture of safety first and quality always within the organization while removing barriers to team performance. Review and approve GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols and summary reports, PFDs, APRs, etc.
Operational Excellence:
Lead and provide cross-functional integration, operational input and effective process support in order to make medicine for the patients we serve. This requires you to partner cross functionally with groups such as Quality, Engineering, Maintenance, and Technical services in on tasks such as manufacturing issue resolution and investigations, champion continuous improvement initiatives, and adhere to operational excellence standards.
Process Optimization:
Develop local processes and procedures to enhance efficiency and effectiveness, utilizing lean tools for success.
Resource Management:
Manage resources effectively, including workload optimization and staffing needs, to meet business objectives. Support Site Leadership to build a diverse and capable organization, supporting the areas of device assembly and packaging.
Collaborative Leadership:
Collaborate closely with cross-functional teams, external partners, central functional organizations, and suppliers to drive alignment and resolve escalated issues. Represent the team on plant flow teams, influencing technical agendas and driving operational results.
Performance Metrics:
Develop and communicate department metrics to drive continuous improvement and ensure alignment with business goals. Develop team goals for safety, quality, and process effectiveness and efficiency.
Innovation and Problem-Solving:
Foster a culture of innovation and creativity, encouraging team members to identify and drive improvement opportunities. This position may deliver equipment, lines, and supporting systems through technology transfers or process validations.
Regulatory Compliance:
Ensure adherence to current regulatory requirements, including cGMP standards, OSHA regulations, and environmental sustainability goals. Support site inspection readiness and execution. This role has direct interaction with Regulatory Agencies during site inspections.
Minimum Requirements:
Bachelor's Degree in Engineering, Science, or a related field.
5+ years of manufacturing experience, pharmaceutical or regulated industry.
3+ years demonstrated leadership skills with a history of successful team development.
Excellent interpersonal, written, and oral communication skills that demonstrate an ability to effectively (clearly, succinctly) communicate with all levels of the organization for decisions, influencing, coaching and mentoring.
Knowledge of cGMP requirements in medical device manufacturing.
Responsible for maintaining a safe work environment and supporting all health, safety, and environmental goals.
Understanding of basic requirements of regulatory agencies such as the FDA, DEKRA, and OSHA.
Additional Preferences and Information:
Experience in device assembly and/or packaging.
Occasional travel may be required to support business needs.
PPE is required on the manufacturing floor.
Previous equipment qualification and process validation experience.
Previous experience with deviation and change management systems including Trackwise.
Join us in this exciting opportunity to drive innovation, foster growth, and make a meaningful impact within the manufacturing landscape at Eli Lilly!
#J-18808-Ljbffr
Are you ready to lead the charge in shaping the future of manufacturing at Eli Lilly? As an Associate Director of Operations, you'll be at the forefront of this exciting journey. In this role within our Device and Packaging Network, you'll not only execute strategies and objectives but also inspire a culture of innovation and excellence. Collaborating with our top-notch team of leaders, you'll influence and implement our organizational agenda, business priorities, and quality objectives to drive success down to the floor level.
Key Objectives/Deliverables:
Empowerment through Development:
Mentor, coach, and recognize team members within your organization to foster growth, achievement and meet the needs of the business.
Strategic Planning:
Engage and support business plan objectives while tracking team performance and ensuring adequate resources are in place for successful implementation.
Safety and Quality Culture:
Lead by example in building and driving a culture of safety first and quality always within the organization while removing barriers to team performance. Review and approve GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols and summary reports, PFDs, APRs, etc.
Operational Excellence:
Lead and provide cross-functional integration, operational input and effective process support in order to make medicine for the patients we serve. This requires you to partner cross functionally with groups such as Quality, Engineering, Maintenance, and Technical services in on tasks such as manufacturing issue resolution and investigations, champion continuous improvement initiatives, and adhere to operational excellence standards.
Process Optimization:
Develop local processes and procedures to enhance efficiency and effectiveness, utilizing lean tools for success.
Resource Management:
Manage resources effectively, including workload optimization and staffing needs, to meet business objectives. Support Site Leadership to build a diverse and capable organization, supporting the areas of device assembly and packaging.
Collaborative Leadership:
Collaborate closely with cross-functional teams, external partners, central functional organizations, and suppliers to drive alignment and resolve escalated issues. Represent the team on plant flow teams, influencing technical agendas and driving operational results.
Performance Metrics:
Develop and communicate department metrics to drive continuous improvement and ensure alignment with business goals. Develop team goals for safety, quality, and process effectiveness and efficiency.
Innovation and Problem-Solving:
Foster a culture of innovation and creativity, encouraging team members to identify and drive improvement opportunities. This position may deliver equipment, lines, and supporting systems through technology transfers or process validations.
Regulatory Compliance:
Ensure adherence to current regulatory requirements, including cGMP standards, OSHA regulations, and environmental sustainability goals. Support site inspection readiness and execution. This role has direct interaction with Regulatory Agencies during site inspections.
Minimum Requirements:
Bachelor's Degree in Engineering, Science, or a related field.
5+ years of manufacturing experience, pharmaceutical or regulated industry.
3+ years demonstrated leadership skills with a history of successful team development.
Excellent interpersonal, written, and oral communication skills that demonstrate an ability to effectively (clearly, succinctly) communicate with all levels of the organization for decisions, influencing, coaching and mentoring.
Knowledge of cGMP requirements in medical device manufacturing.
Responsible for maintaining a safe work environment and supporting all health, safety, and environmental goals.
Understanding of basic requirements of regulatory agencies such as the FDA, DEKRA, and OSHA.
Additional Preferences and Information:
Experience in device assembly and/or packaging.
Occasional travel may be required to support business needs.
PPE is required on the manufacturing floor.
Previous equipment qualification and process validation experience.
Previous experience with deviation and change management systems including Trackwise.
Join us in this exciting opportunity to drive innovation, foster growth, and make a meaningful impact within the manufacturing landscape at Eli Lilly!
#J-18808-Ljbffr