Associate Director-Quality Assurance-Site Data Integrity
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Experteer Overview As Site Data Leader at Lilly, you will own data management and data integrity for the site, leading a data integrity program and the site data lead team. You partner with M&Q Data Management to raise standards and governance, driving continuous improvement and regulatory readiness. You will translate GMP data flows and validation methods into actionable improvements, training, and cross-functional collaboration. This role offers impact across the site and alignment with Lilly’s mission to deliver life-changing medicines. You will work in a fast-paced, problem-solving environment that values initiative and integrity. Compensation / Benefits * Lead data management activities and ensure data integrity at the site * Chair the site data lead team and advocate for a robust Data Integrity Program * Interface with M&Q Data Management to advance corporate quality standards and governance * Collaborate with functional area data experts to anticipates and resolve data management issues * Apply GMP data flow understanding and Computer System Validation to ensure regulatory compliance * Develop and sustain data integrity training programs for continuous improvement * Advance data management standards to improve data consistency and usability for process improvements Tasks * Bachelor’s degree or higher in sciences, engineering, or related field * Minimum 5 years of experience in pharmaceutical manufacturing * Strong project management and organizational skills * Ability to interpret and apply standards to site needs and solve problems * Proven ability to write technical documents and present to senior leadership * Ability to influence strategy and agenda in data integrity * Knowledge of cGMPs, production practices, and quality systems * Understanding of regulations governing data integrity * Willingness to travel domestically and internationally (<10%) * Authorized to work in the United States full-time Key requirements * bonus based on company and individual performance * 401(k) plan * pension * medical, dental, vision, and prescription drug benefits * flexible benefits (FSA) * life insurance and death benefits
Requirements
and issues * Apply GMP data flow understanding and Computer System Validation to ensure regulatory compliance * Develop and sustain data integrity training programs for continuous improvement * Advance data management standards to improve data consistency and usability for process improvements Tasks * Bachelor’s degree or higher in sciences, engineering, or related field * Minimum 5 years of experience in pharmaceutical manufacturing * Strong project management and organizational skills * Ability to interpret and apply standards to site needs and solve problems * Proven ability to write technical documents and present to senior leadership * Ability to influence strategy and agenda in data integrity * Knowledge of cGMPs, production practices, and quality systems * Understanding of regulations governing data integrity * Willingness to travel domestically and internationally (<10%) * Authorized to work in the United States full-time Key requirements * bonus based on company and aaaaaaaaE _ performance * 401(k) plan * pension * medical, dental, vision, and prescription drug benefits * flexible benefits (FSA) * life insurance and death benefits
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