Associate Director, Site Data Integrity and Computer System Validation Lead

Associate Director, Site Data Integrity and Computer System Validation Lead

Position Overview:

The Site Data Leader will have primary responsibility for data management activities within the Lilly Kenosha County (LKC) site. They serve as an advocate for data management across the manufacturing site, chair the site data lead team, and ensure a robust Data Integrity Program exists and is maintained. The role interfaces with the M&Q Data Management organization and acts as a global data management subject matter expert to facilitate improvements in M&Q data-related corporate quality standards, business processes, and governance.

They partner with functional area data experts to anticipate and resolve key data management and integrity issues, drive solutions aligned with corporate objectives, and transition to a site‑based data management and analytics leader role for routine production. The Associate Director, Quality Assurance, also provides computer system quality assurance oversight during start‑up and routine operation of the site.

• Facilitate the Site Data Lead Team.
• Partner with global and site leadership to prioritize data integrity initiatives and secure cross‑functional resources.
• Collaborate with functional site data SMEs to ensure data management actions align with the established plan.
• Maintain Data Flow Maps to identify data integrity risks and define mitigation strategies.
• Implement programs to support data integrity improvements across documents, systems, and processes (e.g., audit trail reviews, user access, walk‑throughs, Site Self‑Inspection).
• Develop and enforce data standards (structure, metadata) and usage guidelines across multiple systems, managing data throughout its lifecycle.
• Drive data strategy actions (digitization, contextualization, visualization) to enable appropriate data use, robust decision making, productivity gains, and continuous improvement.
• Own site actions related to enterprise data management and integrity initiatives.
• Track and report site data management metrics and the status of data integrity action plans.
• Direct the operationalization of data management plans, including transition from paper‑based to digitized solutions.
• Enhance and sustain data management and integrity principles across the data lifecycle.
• Develop, maintain, and enforce the site Data Integrity Strategy.
• Design and deliver learning opportunities to strengthen the global M&Q Quality Culture in data management and integrity; provide training, coaching, feedback, and mentoring.
• Coach individuals on inspection interactions and lead preparation of data integrity topics for audit readiness.
• Network with other sites and central groups to gauge trends and develop internal improvement plans.
• Represent the company during regulatory audits, discussing data integrity expertise with authorities.
• Ensure compliance with Lilly global standards and regulatory guidelines.
• Assess current‑state data management practices, procedures, and system functionality (security, ER/ES, audit trails, data mapping, backup, retention, CSVA, qualification, investigations, training).
• Serve as the site liaison to the Global Data Management organization, providing feedback for improvement opportunities.
• Act as a global data management SME to facilitate and drive improvements in M&Q data standards, processes, and governance.
• Consult with Network and Global quality groups to ensure consistent, compliant project startup and design.
• Provide technical and quality review of project computer system documents, ensuring compliance with Lilly global standards and local procedures.
• Support the development of the site quality vision and strategy with a focus on CSQA topics.
• Build technical capability across cross‑functional teams and mentor new qualified staff.
• Lead project initiatives supporting the project and quality functions.
• Resolve or escalate compliance issues to project, site, and quality management.
• Participate in self‑led inspections and support during internal/external regulatory inspections.
• Ensure data integrity by design and leverage technology for data digitization and standardization.
• Design, replicate, and employ analytics and…