Associate Director - Business Solutions - MQ Tech at Lilly
Scorpion Therapeutics, Pleasant Prairie, Wisconsin, United States, 53158
Role Summary
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 role supports 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. Responsibilities
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; collaborate with stakeholders; participate in cross-functional leadership teams; benchmark innovative solutions. Team Leadership And Development
— Lead a group of 7+ associates; manage recognition, compensation, talent assessment and succession planning; provide coaching and professional development; foster cross-functional communication; demonstrate Lilly values and operational excellence; support site leadership initiatives including recruiting and mentoring. IT Operations Management
— Ensure reliable and secure operation of key systems (MES, QC/QA systems, networks, endpoints, storage); oversee data and digital strategy; maintain robust computer system validation and data integrity; oversee disaster recovery and business continuity; define and report capability measures; manage third party relationships for key system support (including MES). Project And Financial Management
— Participate in site IT budget preparation; evolve the site IT operational roadmap; lead IT projects from requirements to deployment within budget; monitor progress, manage risks, keep stakeholders informed. Compliance And Regulatory Adherence
— Ensure system compliance with FDA guidelines, GMP requirements, Lilly policy; enforce security protocols and privacy compliance; facilitate inspections and findings management. Qualifications
Required:
Bachelor’s degree in Software Engineering, Computer Science, Computer Engineering, Information Technology or related field. Required:
7+ years of IT leadership experience in a GMP-regulated industry. Required:
Experience developing and maintaining Manufacturing Execution Systems, QC/QA systems, or data analytics. Required:
Experience with IT service management (ITIL) and ensuring incident management, problem resolution, and/or change management processes. Preferred:
Proven track record delivering complex IT projects within scope, budget, and schedule; experience with Agile and Waterfall methodologies; knowledge of CFR 21 Part 11 computer system validation; experience with audits and remediation; familiarity with cloud, IoT, AI, and data analytics applications in pharma; global organization experience; ISA-95 and OT systems familiarity; strong communication and cross-functional collaboration skills. Education
Bachelor’s degree in Software Engineering, Computer Science, Computer Engineering, Information Technology or related field (as listed under Required).
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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 role supports 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. Responsibilities
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; collaborate with stakeholders; participate in cross-functional leadership teams; benchmark innovative solutions. Team Leadership And Development
— Lead a group of 7+ associates; manage recognition, compensation, talent assessment and succession planning; provide coaching and professional development; foster cross-functional communication; demonstrate Lilly values and operational excellence; support site leadership initiatives including recruiting and mentoring. IT Operations Management
— Ensure reliable and secure operation of key systems (MES, QC/QA systems, networks, endpoints, storage); oversee data and digital strategy; maintain robust computer system validation and data integrity; oversee disaster recovery and business continuity; define and report capability measures; manage third party relationships for key system support (including MES). Project And Financial Management
— Participate in site IT budget preparation; evolve the site IT operational roadmap; lead IT projects from requirements to deployment within budget; monitor progress, manage risks, keep stakeholders informed. Compliance And Regulatory Adherence
— Ensure system compliance with FDA guidelines, GMP requirements, Lilly policy; enforce security protocols and privacy compliance; facilitate inspections and findings management. Qualifications
Required:
Bachelor’s degree in Software Engineering, Computer Science, Computer Engineering, Information Technology or related field. Required:
7+ years of IT leadership experience in a GMP-regulated industry. Required:
Experience developing and maintaining Manufacturing Execution Systems, QC/QA systems, or data analytics. Required:
Experience with IT service management (ITIL) and ensuring incident management, problem resolution, and/or change management processes. Preferred:
Proven track record delivering complex IT projects within scope, budget, and schedule; experience with Agile and Waterfall methodologies; knowledge of CFR 21 Part 11 computer system validation; experience with audits and remediation; familiarity with cloud, IoT, AI, and data analytics applications in pharma; global organization experience; ISA-95 and OT systems familiarity; strong communication and cross-functional collaboration skills. Education
Bachelor’s degree in Software Engineering, Computer Science, Computer Engineering, Information Technology or related field (as listed under Required).
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