Associate Director - Business Solutions M&Q Tech at Lilly
Eli Lilly and Company
6 months ago
On-site
Pleasant Prairie, WI
IT
IT Associate Director – Lilly Kenosha
Key Objectives/Deliverables
Strategic Leadership
- Oversee execution of the Kenosha IT strategy aligned with Manufacturing & Quality IT Digital Strategy and the Kenosha ramp-up schedule.
- Identify and prioritize innovative technology initiatives supporting pharmaceutical manufacturing 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).
Team Leadership and Development
- Lead a group of 7+ associates, managing recognition, compensation, talent assessment, and succession planning.
- Provide coaching and professional development opportunities to promote growth, retention, innovation, and continuous learning.
- Foster cross-functional communication and collaboration to align IT solutions with business needs.
- Demonstrate values, expectations, and operational excellence standards.
- Support site leadership initiatives, including recruiting and mentoring.
IT Operations Management
- Ensure reliable and secure operation of key systems (Manufacturing Execution System, QC systems, QA systems) and associated networks, endpoints, and storage to minimize downtime and maximize efficiency.
- Oversee execution of the Kenosha data and digital strategy; measure value against global and local targets.
- Maintain computer system validation and data integrity capabilities per global standards to protect data and intellectual property.
- Oversee disaster recovery and business continuity planning for key systems.
- Define and report capability measures for key systems and processes following LEAN principles.
- Own third-party relationships for key system support services (including MES).
Project and Financial Management
- Participate in preparation of the site IT budget.
- Implement and manage evolution of the site IT operational roadmap using local/global partnerships and in response to internal/external trends.
- Lead and manage IT projects from requirements through development and deployment; deliver on scope, schedule, and budget.
- Monitor project progress, manage risks, and adjust plans as needed.
- Keep stakeholders informed of accomplishments, goals, and progress.
Compliance and Regulatory Adherence
- Ensure systems comply with FDA/GMP requirements, Lilly policies/procedures, and local procedures to maintain product quality and safety.
- Enforce security protocols to protect confidential information and ensure privacy compliance.
- Facilitate internal and external inspections by coaching/overseeing IT-related topics and ensure timely findings management.
Basic Qualifications
- Bachelor’s degree in Software Engineering, Computer Science, Computer Engineering, Information Technology, or related field.
- 7+ years of IT leadership experience in GMP-regulated industry.
- Experience developing and maintaining Manufacturing Execution Systems.
- Experience with ITSM frameworks such as ITIL (incident management, problem resolution, and/or change management).
Additional Skills/Preferences
- Proven track record leading complex IT projects within scope, budget, and schedule.
- Experience with QC systems, QA systems, and/or data analytics.
- Experience with Agile and Waterfall; tailor approach to project requirements.
- In-depth understanding and experience implementing/maintaining CFR 21 Part 11 validation.
- Experience with audits, compliance assessments, findings management, and remediation.
- Understanding of emerging technologies (cloud, IoT, AI, data analytics) for pharma applications.
- Demonstrated experience executing IT strategies aligned with business goals and industry best practices.
- Strong team management; 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.
- Creativity, analytical thinking, and strong troubleshooting/problem-solving.
- Adaptability in a fast-paced environment; ability to manage multiple tasks.
- Excellent communication and interpersonal skills for cross-functional stakeholder collaboration.
Benefits (explicitly stated)
- Company bonus (for full-time equivalent employees; depends on company/individual performance).
- Comprehensive benefits program for eligible employees, including 401(k), pension, vacation, medical/dental/vision/prescription benefits, flexible benefits, life insurance, time off/leave, and well-being benefits.
Application Instructions
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation
Key Objectives/Deliverables
Strategic Leadership
- Oversee execution of the Kenosha IT strategy aligned with Manufacturing & Quality IT Digital Strategy and the Kenosha ramp-up schedule.
- Identify and prioritize innovative technology initiatives supporting pharmaceutical manufacturing 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).
Team Leadership and Development
- Lead a group of 7+ associates, managing recognition, compensation, talent assessment, and succession planning.
- Provide coaching and professional development opportunities to promote growth, retention, innovation, and continuous learning.
- Foster cross-functional communication and collaboration to align IT solutions with business needs.
- Demonstrate values, expectations, and operational excellence standards.
- Support site leadership initiatives, including recruiting and mentoring.
IT Operations Management
- Ensure reliable and secure operation of key systems (Manufacturing Execution System, QC systems, QA systems) and associated networks, endpoints, and storage to minimize downtime and maximize efficiency.
- Oversee execution of the Kenosha data and digital strategy; measure value against global and local targets.
- Maintain computer system validation and data integrity capabilities per global standards to protect data and intellectual property.
- Oversee disaster recovery and business continuity planning for key systems.
- Define and report capability measures for key systems and processes following LEAN principles.
- Own third-party relationships for key system support services (including MES).
Project and Financial Management
- Participate in preparation of the site IT budget.
- Implement and manage evolution of the site IT operational roadmap using local/global partnerships and in response to internal/external trends.
- Lead and manage IT projects from requirements through development and deployment; deliver on scope, schedule, and budget.
- Monitor project progress, manage risks, and adjust plans as needed.
- Keep stakeholders informed of accomplishments, goals, and progress.
Compliance and Regulatory Adherence
- Ensure systems comply with FDA/GMP requirements, Lilly policies/procedures, and local procedures to maintain product quality and safety.
- Enforce security protocols to protect confidential information and ensure privacy compliance.
- Facilitate internal and external inspections by coaching/overseeing IT-related topics and ensure timely findings management.
Basic Qualifications
- Bachelor’s degree in Software Engineering, Computer Science, Computer Engineering, Information Technology, or related field.
- 7+ years of IT leadership experience in GMP-regulated industry.
- Experience developing and maintaining Manufacturing Execution Systems.
- Experience with ITSM frameworks such as ITIL (incident management, problem resolution, and/or change management).
Additional Skills/Preferences
- Proven track record leading complex IT projects within scope, budget, and schedule.
- Experience with QC systems, QA systems, and/or data analytics.
- Experience with Agile and Waterfall; tailor approach to project requirements.
- In-depth understanding and experience implementing/maintaining CFR 21 Part 11 validation.
- Experience with audits, compliance assessments, findings management, and remediation.
- Understanding of emerging technologies (cloud, IoT, AI, data analytics) for pharma applications.
- Demonstrated experience executing IT strategies aligned with business goals and industry best practices.
- Strong team management; 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.
- Creativity, analytical thinking, and strong troubleshooting/problem-solving.
- Adaptability in a fast-paced environment; ability to manage multiple tasks.
- Excellent communication and interpersonal skills for cross-functional stakeholder collaboration.
Benefits (explicitly stated)
- Company bonus (for full-time equivalent employees; depends on company/individual performance).
- Comprehensive benefits program for eligible employees, including 401(k), pension, vacation, medical/dental/vision/prescription benefits, flexible benefits, life insurance, time off/leave, and well-being benefits.
Application Instructions
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation