Associate Director - Business Solutions - MQ Tech at Lilly

Eli Lilly and Company • Pleasant Prairie, WI

4d • Onsite

About The Position

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. Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. This is an exciting once-in-a-lifetime opportunity to work in a state-of-the-art manufacturing site, in Pleasant Prairie, Wisconsin. The facility will utilize the latest technology to increase the company's manufacturing capacity in parenteral (injectable) medications, device assembly and packaging operations. The Lilly Kenosha site will leverage use of high-tech equipment, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment. The IT Associate Director –Lilly Kenosha is responsible for the smooth operation of critical IT systems used within the manufacturing, warehouse, and Quality Control Labs at the Lilly Kenosha manufacturing site. The Associate Director assists the Senior Director in overseeing the site IT footprint and driving technological advancements in alignment with global IT standards. Leading a talented team, you will implement strategic and operational IT initiatives to support the production of life-saving medicines, ensuring the availability, reliability and performance. Key Objectives/Deliverables Strategic Leadership: Oversee execution of the Kenosha IT strategy, aligned with the Manufacturing & Quality IT Digital Strategy and the Kenosha ramp-up schedule. Identify and prioritize innovative technology initiatives that support the pharmaceutical manufacturing site's growth and compliance requirements. Collaborate with stakeholders to gain support and alignment on strategic IT initiatives. Participate in cross-functional leadership teams at the site and global levels. Benchmark on innovative solutions (external and internal to Lilly). Team Leadership and Development: Lead a group of 7 or more associates, managing recognition, compensation, talent assessment and succession planning activities. Provide coaching and professional development opportunities to team members, promoting their growth and retention, emphasizing innovation and continuous learning. Foster effective cross-functional communication and collaboration at the site and global levels to align IT solutions with business needs. Demonstrate Lilly values, expectations, and operational excellence standards . Support site leadership initiatives, including recruiting and mentoring. IT Operations Management: Ensure the reliable and secure operation of key systems to minimize downtime and maximize operational efficiency: Manufacturing Execution System, QC systems, QA systems, and their associated networks, endpoints, and storage. Oversee execution of the Kenosha data and digital strategy, measuring value against globally and locally defined targets. Maintain robust computer system validation and data integrity capabilities, following globally defined standards, to protect data and intellectual property. Oversee disaster recovery and business continuity planning of key systems to ensure uninterrupted operations. Define and report capability measures for key systems and processes, following LEAN principles. Own third party relationships for key system support services, including Manufacturing Execution System. Project and Financial Management: Participate in preparation of the site IT budget following the annual schedule. Implement and manage evolution of the site IT operational roadmap, leveraging partnerships with local and global peers, and in response to internal and external trends. Lead and manage IT projects, from requirements, through development and deployment. Ensure timely and successful delivery within allocated budgets and resources. Monitor project progress, identify, and address risks, and adjust plans as needed to ensure project success. Keep key stakeholders informed and engaged of accomplishments, goals, and progress. Compliance and Regulatory Adherence: Ensure system compliance with industry-specific regulations, such as FDA guidelines and GMP requirements, Lilly corporate policy and procedures, and local procedures to maintain product quality and safety. Enforce security protocols to protect confidential information and ensure privacy compliance. Facilitate execution of internal and external inspections by coaching and overseeing IT-related topics, and ensure timely execution of findings management.

Requirements

• Bachelor’s degree in Software Engineering, Computer Science, Computer Engineering, Information Technology or a related field.
• 7+ years of IT leadership experience working in GMP regulated industry.
• Experience developing and maintaining Manufacturing Execution Systems, QC Systems, QA systems, or data analytics.
• Experience with IT service management (ITSM) frameworks like ITIL, ensuring efficient incident management, problem resolution, and/or change management processes.

Nice To Haves

• Proven track record in successfully leading and delivering complex IT projects within scope, budget, and schedule.
• Experience with Agile and Waterfall project management methodologies, and the ability to tailor approaches based on project requirements.
• In-depth understanding and experience implementing and maintaining compliance to CFR 21 Part 11 computer system validation regulations.
• Experience with audits, compliance assessments, findings management, remediation.
• Understanding of emerging technologies like cloud computing, IoT, AI, and data analytics, and their potential applications in the pharmaceutical industry.
• Demonstrated experience in executing IT strategies aligned with business goals and industry best practices.
• Strong team management skills, with the ability to inspire, motivate, and develop high-performing IT teams.
• Experience working in a global organization.
• Familiarity with ISA-95 architecture framework and Operational Technology (OT) systems
• Previous experience with Agile or LEAN
• Demonstrated creativity, analytical thinking, and the ability to troubleshoot and solve problems.
• Adaptability and flexibility to work in a fast-paced, dynamic environment and manage multiple tasks simultaneously.
• Experience in facilitating cross-functional collaboration, aligning IT initiatives with business needs and fostering a culture of innovation and operational excellence.
• Excellent communication and interpersonal skills to collaborate effectively with stakeholders at all levels of the organization.

Responsibilities

• Oversee execution of the Kenosha IT strategy, aligned with the Manufacturing & Quality IT Digital Strategy and the Kenosha ramp-up schedule.
• Identify and prioritize innovative technology initiatives that support the pharmaceutical manufacturing site's growth and compliance requirements.
• Collaborate with stakeholders to gain support and alignment on strategic IT initiatives.
• Participate in cross-functional leadership teams at the site and global levels.
• Benchmark on innovative solutions (external and internal to Lilly).
• Lead a group of 7 or more associates, managing recognition, compensation, talent assessment and succession planning activities.
• Provide coaching and professional development opportunities to team members, promoting their growth and retention, emphasizing innovation and continuous learning.
• Foster effective cross-functional communication and collaboration at the site and global levels to align IT solutions with business needs.
• Demonstrate Lilly values, expectations, and operational excellence standards .
• Support site leadership initiatives, including recruiting and mentoring.
• Ensure the reliable and secure operation of key systems to minimize downtime and maximize operational efficiency: Manufacturing Execution System, QC systems, QA systems, and their associated networks, endpoints, and storage.
• Oversee execution of the Kenosha data and digital strategy, measuring value against globally and locally defined targets.
• Maintain robust computer system validation and data integrity capabilities, following globally defined standards, to protect data and intellectual property.
• Oversee disaster recovery and business continuity planning of key systems to ensure uninterrupted operations.
• Define and report capability measures for key systems and processes, following LEAN principles.
• Own third party relationships for key system support services, including Manufacturing Execution System.
• Participate in preparation of the site IT budget following the annual schedule.
• Implement and manage evolution of the site IT operational roadmap, leveraging partnerships with local and global peers, and in response to internal and external trends.
• Lead and manage IT projects, from requirements, through development and deployment.
• Ensure timely and successful delivery within allocated budgets and resources.
• Monitor project progress, identify, and address risks, and adjust plans as needed to ensure project success.
• Keep key stakeholders informed and engaged of accomplishments, goals, and progress.
• Ensure system compliance with industry-specific regulations, such as FDA guidelines and GMP requirements, Lilly corporate policy and procedures, and local procedures to maintain product quality and safety.
• Enforce security protocols to protect confidential information and ensure privacy compliance.
• Facilitate execution of internal and external inspections by coaching and overseeing IT-related topics, and ensure timely execution of findings management.

Benefits

• Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
• In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees