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. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Responsibilities: Eli Lilly is committed to laboratory and manufacturing system modernization and integration, leading industry standard. The Quality Data Integrity professional works independently within Lilly cross-functional groups to build Quality and Data Integrity principles into paper based and computer systems lifecycle processes, focusing in the QC areas. Additionally, this role will partner with functional Data Integrity leads around Lilly and collaborate with QA compliance leadership to anticipate Data Integrity needs while permanent driving solutions to enhance the Data Integrity culture. Active member of the site Data Integrity governance committee. Ensure compliance with applicable Lilly global standards and regulatory guidelines. Represent the site on global DI-related forums to ensure industry and Lilly data integrity enhancements are implemented as expected. At the same time, provide feedback to the global DI-related forums as needed. Monitor the well-being of data integrity culture with the QC organization to proactively identify areas of improvements. Develop, own, and perform data integrity training for QC personnel to communicate, build, and train on data integrity principles and controls in-place. Perform and own data integrity assessments for new and existing laboratory systems. Participate on quality investigations and/or deviations pertaining to DI. Support the assessments and effectiveness checks of quality records and implementations via TrackWise records and trends to enhance and maintain data integrity culture as appropriate. Participate in the development of User and Functional Requirements during the acquisition/upgrade of laboratory technologies. Perform process data flow mapping and assist with mitigation planning for identified vulnerabilities. Lead and participate in quality walkthroughs and/or internal audits, as needed, to provide technical inputs and ensure systems are used and maintained in a state of control. Ensure data integrity readiness for inspections and participate as necessary. Basic Requirements: BA/BS degree in the sciences, engineering, IT or related field with 3-5 years of experience in GMP operations within the Biopharmaceutical industry. Must have working experience on computer systems validation and development lifecycle based on international guidance and regulations (i.e. GAMP 5, 21 CFR Part 11, annex 11) data integrity compliance requirements for GMP regulated environments. Additional Skills/Preferences: Must have experience leading data integrity practices and culture change. Risk-based mindset, able to level-load data integrity controls based on established regulations and data criticality. Possesses an understanding of laboratory system designs (data-process mapping, data lifecycle, etc) and can help evaluate and communicate system vs procedural controls based on data criticality and associated risks to the product. Work independently with minimal supervisory guidance. Exhibit strong teamwork skills. Must have the ability to function in a fast-paced, cross-functional environment and effectively communicate cross-functionally. Other Information: Travel not required. Lifting not required. Required to be on call. Shift work may apply. Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leaders
Location: Anywhere
Posted: Aug. 14, 2024, 6:05 p.m.
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