Associate Director - It

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 designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility in Raleigh-Durham North Carolina.  This is an exciting opportunity to help build a state-of-the-art facility from the ground up as a member of the site IT organization.
Responsibilities:
The IT Associate Director –RTP is responsible for the smooth operation of critical IT systems used within the manufacturing, warehouse, and Quality Control Labs at the Research Triangle Park (RTP) 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, IT team leadership, financial management, and regulatory compliance, to support the production of life-saving medicines.

1. Strategic Leadership

• Oversee execution of the RTP IT strategy, aligned with the Manufacturing & Quality IT Digital Strategy and the RTP 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).

2. 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.

3. IT Operations Management

• Ensure the reliable and secure operation of key systems to minimize downtime and maximize operational efficiency: Manufacturing Execution System, Warehouse Management system, QC systems, and their associated networks, endpoints, and storage.
• Maintain robust cybersecurity and data integrity capabilities, following globally defined standards, to protect sensitive 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 and Warehouse Management system.

4. 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.

5. 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 internal and external inspections of IT systems and processes and ensure timely response to any findings.

Basic Requirements:

• Bachelor’s degree in Software Engineering, Computer Science, Computer Engineering, or a related field.
• Minimum of 7+ years of IT leadership experience working in GMP regulated industry.
• Experience developing and maintaining Manufacturing Execution Systems, Warehouse Management Systems, or QC Systems.

Additional Skills/Preferences:

• Experience with IT service management (ITSM) frameworks like ITIL, ensuring efficient incident management, problem resolution, and change management processes.
• 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.

Additional Information:

• Travel < 10%
• Shift information: First shift Monday-Friday, with occasional extended hours or weekends for support or project delivery.
• Position location: Durham, North Carolina

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