Associate Director, Quality Assurance – Site Data Leader

Role Summary

Associate Director, Quality Assurance – Site Data Leader. The Site Data Leader is responsible for data management activities at the Lilly Kenosha County site, oversees the Data Integrity Program, and provides quality assurance oversight during start-up and routine operations, with a transition to a site-based data management and analytics leadership role for routine production.

Responsibilities

• Develop and maintain a comprehensive and integrated data integrity and data management program
• Facilitate the Site Data Lead Team and partner with global and site leadership to prioritize data integrity initiatives
• Collaborate with functional site data SMEs to complete data management actions per plan
• Maintain Data Flow Maps to identify data integrity risks and define mitigation strategies
• Support data integrity improvements to documents, systems, and processes (e.g., audit trails, user access, site self inspections)
• Implement data standards and usage guidelines, manage data lifecycle across systems/functions
• Execute data strategy actions (digitization, contextualization, visualization) for informed decision making
• Own site actions related to enterprise data management and integrity initiatives
• Maintain site data management metrics and report status to the Site Data Lead Team
• Operationalize the data management action plan, transitioning from paper-based to digitized solutions
• Enhance and sustain data management and integrity principles throughout the data lifecycle
• Develop and implement the site Data Integrity Strategy
• Design and deliver learning opportunities and provide training, coaching, and mentoring on data management and integrity
• Coach individuals on inspection interactions and lead preparation for audit and inspection readiness
• Network with other sites and central groups to understand external trends and drive internal improvements
• Ensure regulatory inspection readiness and represent the company in regulatory discussions related to data integrity
• Ensure compliance with Lilly global standards and regulatory guidelines
• Participate in assessments of current-state data practices, systems, and controls (ER/ES, audit trails, data mapping, backups, computer system validation, infrastructure qualification, training)
• Act as site liaison with Global Data Management and form the data community of practice; serve as a global data management SME for data-related standards and governance
• Lead CSQA-related activities as Computer Systems Validation Quality Assurance Project Lead, ensuring integration of Global Quality System requirements

Qualifications

• Bachelor's degree required; engineering or computer science-related field preferred
• Minimum 5 years in the pharmaceutical or medical device industry in QA roles
• Minimum 3 years of experience in Computer System Quality Assurance/Computer System Validation
• Minimum 3 years of experience with data analytics including advanced analytics

Additional Skills

• Experience leading cross-functional teams and project management
• Proficiency with GMP computer systems validation and regulatory requirements
• Knowledge of data integrity regulatory guidance
• Ability to apply analytics and advanced analytics to manufacturing operations
• Strong oral and written communication
• Self-management and organizational skills
• Interpersonal skills and ability to influence cross-functional groups
• Technical writing skills and problem-solving abilities
• Facility or area start-up experience; qualification/validation experience in process automation or IT systems
• Six Sigma Green Belt or Lean training/experience; ASQ CQA certification preferred

Education

• Bachelor's degree required; engineering or computer science-related field preferred

Additional Requirements

• Onsite presence with flexible time; ability to work overtime as required
• Ability to travel up to 10%