Sr. Director – Clinical Trial Plant Project Lead

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.

Maximise your chances of a successful application to this job by ensuring your CV and skills are a good match.

Organization Overview

LRL (Lilly Research Laboratories) Tech at Lilly unites science with technology to accelerate the LRL pipeline and deliver therapeutic innovations.

As a member of the LRL Tech at Lilly organization, you will have the opportunity to work in a highly technical and fast-paced team in a scientifically challenging area responsible for delivering life-changing medicines and treatments.

What You’ll Be Doing

Sr. Director Clinical Trial Plant Project Lead will be responsible for ensuring the delivery of the Tech at Lilly milestones (Infrastructure, Applications, Data Infrastructure, and Architecture) to ensure operational readiness on time with the schedule.

• Ensure site operational readiness from IT perspective. Site start-up and integration of IT systems including :
• Infrastructure
• Enterprise Resource Planning
• Warehouse management & logistics coordination
• Manufacturing Execution System
• Biometric enrolment & authentication
• Data historian, Real Time Floor Tracking
• Data Integration
• Data Analytics
• Data Integrity
• Digital Plant
• Laboratory information managements
• CAPA systems
• Access Security
• Building Monitoring
• Risk Management
• MES (Manufacturing Execution System)
• Ensure full integrated schedule to deliver the Tech at Lilly is in place
• Member of the Site Leadership Team and work closely with the PRD Tech at Lilly Sr Director Leader
• Benchmark on innovative solutions (external and internal to Lilly)
• Dynamically adapt roadmap to site evolution / strategic directions, and new trends / issues
• Partner cross-functionally locally and globally to establish and implement site IT roadmap
• Responsible for maintaining a safe work environment.
• Responsible to manage Business Plan assessment, budget, capital.
• Lead, coach, and develop members of the team.
• Support site recruiting building IT capability.
• Provide leadership in the development and execution of cGMP and / or improvement plans within the IT function and in support of site cGMP improvement plans.
• Define and execute IT inspection readiness activities.
• Ensure the full Tech at Lilly agenda is delivered under the DI expectations.
• Provide prioritization and barrier removal
• Provide oversight of technical activities within the group
• Effectively encourage knowledge sharing and education

Your Basic Requirements

• Bachelor’s degree in scientific, business, or IT-related field
• 10+ years IT leadership experience working in Pharma and Manufacturing and Quality, especially API Manufacturing
• 5+ years of strong experience with MES system implementations, Data Integration, and Advanced Analytics
• Regulatory compliance knowledge and experience (cGMP)

Additional Skills / Preferences

• Demonstrated Learning agility and commitment to learning
• Demonstrated experience in leading the development of IT strategy for a business area
• Demonstrated ability to broadly influence senior leadership (Business and Tech at Lilly) across the organization
• Effective people and team leadership skills
• Ability to manage and contribute to multiple concurrent activities and adapt to changes in priorities.
• Ability to cross-functionally collaborate
• Excellent written and oral communication skills
• Demonstrated creativity, analytical thinking, and the ability to troubleshoot and solve problems
• Experience in technical leadership of internal and external software development teams
• Knowledge of Agile framework and delivering in an Agile environment
• Knowledge of DevSecOps quality, project management, and software development approaches

Additional Information

This role is located in Indianapolis, IN with a hybrid work model

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