Associate Director, Site Data Integrity and Computer System Validation Lead

Posted Date

11/16/2025

Description

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.

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.

Position Overview:

The Site Data Leader will have primary responsibility for data management activities within the Lilly Kenosha County (LKC) site. The Site Data Leader is an advocate for data management across the manufacturing site and chairs the site data lead team.

The Site Data Leader ensures a robust Data Integrity Program exists and is maintained within the site providing strong project management leadership to advance the site's agenda. This requires interface with the M&Q Data Management organization, serving as a global data management subject matter expert to facilitate and drive improvements in M&Q data-related corporate quality standards, business processes, organizational design, and governance necessary for ongoing data integrity effectiveness. This role will partner with functional area data experts to anticipate and resolve key data management and integrity issues while driving solutions that impact the site and align with corporate objectives. The Associate Director, Quality Assurance, will also provide computer system quality assurance oversight during the start-up and routine operation of the Lilly Kenosha County site. In addition, this role will transition to a site-based data management and analytics leader role for routine production. This role will leverage a deep understanding of GMP data flows (electronic and paper), the application of data management and integrity principles in operational processes, and Computer System Validation methodologies to ensure regulatory compliance, consistency, and sustainment.

The Site Data Leader is responsible for ensuring education and continuous knowledge on data integrity and data management at the site. This role influences improving data management standards to ensure consistency and consumability of data to drive process improvements. This role ensures compliance and inspection readiness of the data integrity and data management program at the site level. The Site Data Leader is responsible for ensuring the site's data integrity training program facilitates the sustainment of its data integrity continuous improvement journey. The Site Data Leader reports to the Site Quality Leader and has dotted-line accountability to Global Data Management leadership. This is an individual contributor role with responsibility for technical leadership, as well as project management.

Responsibilities:

The Site Data Leader will have primary responsibility for data management activities within the Lilly Kenosha County (LKC) site. The Site Data Leader is an advocate for data management across the manufacturing site and chairs the site data lead team.

The Site Data Leader ensures a robust Data Integrity Program exists and is maintained within the site providing strong project management leadership to advance the site's agenda. This requires interface with the M&Q Data Management organization, serving as a global data management subject matter expert to facilitate and drive improvements in M&Q data-related corporate quality standards, business processes, organizational design, and governance necessary for ongoing data integrity effectiveness. This role will partner with functional area data experts to anticipate and resolve key data management and integrity issues while driving solutions that impact the site and align with corporate objectives. The Associate Director, Quality Assurance, will also provide computer system quality assurance oversight during the start-up and routine operation of the Lilly Kenosha County site. In addition, this role will transition to a site-based data management and analytics leader role for routine production. This role will leverage a deep understanding of GMP data flows (electronic and paper), the application of data management and integrity principles in operational processes, and Computer System Validation methodologies to ensure regulatory compliance, consistency, and sustainment.

The Site Data Leader is responsible for ensuring the education and continuous knowledge on data integrity and data management at the site. This role influences improving data management standards to ensure consistency and consumability of data to drive process improvements. This role ensures compliance and inspection readiness of the data integrity and data management program at the site level. The Site Data Leader is responsible for ensuring the site's data integrity training program facilitates the sustainment of its data integrity continuous improvement journey. The Site Data Leader reports to the Site Quality Leader and has dotted-line accountability to Global Data Management leadership. This is an individual contributor role with responsibility for technical leadership, as well as project management.

Key Objectives/Deliverables

Develop and maintain a comprehensive and integrated data integrity and data management program:

• Facilitate the Site Data Lead Team
• Partner with global and site leadership to ensure data integrity initiatives are given appropriate priority and cross functional resources.
• Partner with functional site data subject matter experts (SMEs) to ensure that data management actions are completed in accordance with established plan.
• Ensure completion and maintenance of Data Flow Maps as applicable to identify data integrity risks and define mitigation strategies.
• Ensure programs are in place to facilitate and support data integrity improvements to documents, systems, and processes (e.g., audit trail reviews, user access, walk-throughs, Site Self Inspection).
• Implement defined data standards (e.g., data structure, metadata) and usage guidelines as information passes through multiple systems / functions and ensure processes are in place to manage the data throughout its lifecycle.
• Implement data strategy actions (e.g., digitization, contextualization, visualization) to enable appropriate use of data at the appropriate time to enable robust decision making, drive productivity, and facilitate continuous improvement.

Lead initiatives related to data integrity and data management for GMP information at the site:

• Own site actions associated with the enterprise data management and integrity initiatives.
• Maintain site data management metrics and track status of the data integrity action plans; report the status to the Site Data Lead Team.
• Provide direction on the operationalization of the data management action plan including the transition from paper-based processes to digitized solutions.
• Own the responsibility for enhancing and sustaining data management and integrity principles throughout the data lifecycle.
• Own the development, maintenance, and be accountable for the implementation of the site Data Integrity Strategy

Ensure continuous professional development, education, training and knowledge