Associate Director-Quality Assurance-Site Data Integrity

Eli Lilly and Company
Indianapolis, IN, United States
4 days ago

Role details

Contract type
Permanent contract
Employment type
Full-time (> 32 hours)
Experience level
Expert
Experience required
5 years minimum
Working hours
Regular working hours

Tech stack

Data Integrity Data Streaming System Testing Data Management

Job description

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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