Associate Director, Quality Assurance – Site Data Leader 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. 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. Position Overview: 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. Responsibilities: Develop and maintain a comprehensive and integrated data integrity and data management program. Lead initiatives related to data integrity and data management for GMP information at the site. Ensure continuous professional development, education, training and knowledge transfer of data integrity and data management principles. Ensure compliance and inspection readiness of the data integrity and data management program at the site level. Act as site liaison and representative for the data integrity and data management program. Basic Requirements: Bachelor's degree required; engineering or computer science-related field preferred. Minimum 5 years working 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/Preferences: Demonstrated successful leadership of cross-functional teams and project management experience. Demonstrated proficiency with GMP computer systems validation including regulations governing them. Demonstrated knowledge and application of data integrity regulatory guidance. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

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