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.OverviewThe ideal candidate will bring deep expertise in data integrity, data governance, and Manufacturing and Quality execution documentation and records. This position is crucial to ensure newly acquired and pre-operational sites are fully prepared to meet Lilly’s high standards for data accuracy, consistency, and reliability throughout the stages of their integration.As a member of the Global Information Systems Quality (GISQ) organization, the GMP Data Integrity SME, working in close partnership with the GISQ Mergers &amp; Acquisitions group, will be responsible for evaluating data integrity controls and developing integration roadmaps for newly acquired sites. This role will also drive the development of data integrity playbooks in collaboration with site leadership and SMEs at greenfield sites and serve as a core team member in establishing data integrity programs at those sites. This role requires a strong understanding of data management principles, data governance frameworks, and regulatory requirements pertaining to data integrity, as well as the ability to collaborate optimally with specialists and site management during the integration of their facilities into the Lilly organization.<h1>Responsibilities</h1><ul><li>Lead data integrity initiatives during M&amp;A activities, ensuring seamless integration and accuracy of data.</li><li>Develop and implement data governance frameworks to support M&amp;A processes.</li><li>Collaborate with cross-functional teams to identify data-related challenges and provide solutions.</li><li>Conduct thorough process output and data assessments to ensure compliance with regulatory data integrity standards.</li><li>Establish best practices for data management and integration post-merger or acquisition, or early stage greenfield sites.</li><li>Provide training and support to external manufacturing teams on data integrity and governance policies; owning any specific curriculum</li><li>Monitor and report on data integrity metrics, identifying areas for improvement.</li><li>Stay updated with industry trends and advancements in data integrity and M&amp;A practices.</li><li>Influence the Working-with-Third-Parties Process Owner and Contract Mfg / Contract Lab to ensure Data Integrity Quality Oversight</li></ul><h1>Qualifications</h1><ul><li>Bachelor’s degree in a Science, Technology, Engineering, or Mathematics</li><li>Minimum of 5 years of experience in data integrity, data governance, or related roles in GMP in a GMP environment.</li></ul><h1>Preferred Qualifications</h1><ul><li>Willingness and ability to travel for up to 65% of the year, including internationally</li><li>Strong analytical skills with the ability to interpret complex data sets.</li><li>Excellent communication and collaboration skills.</li><li>Proficiency in data management tools and software.</li><li>Knowledge of regulatory requirements and industry standards related to data integrity.</li><li>Ability to work in a fast-paced and dynamic environment.</li><li>Experience in M&amp;A processes</li><li>Experience with Quality oversight for Contract Partners (Manufacturing and/or Labs)</li><li>Certification or qualification in Quality or Business Auditing</li><li>Computer system validation experience</li><li>Bi- or Multilingualism a plus</li></ul><h1>Additional Information</h1><ul><li>25-65% travel anticipated, ability to travel internationally</li></ul>Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (<a target="_blank" href="https://careers.lilly.com/us/en/workplace-accommodation">https://careers.lilly.com/us/en/workplace-accommodation</a>) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.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. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is$126,000 - $184,800<h3></h3>Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.#WeAreLilly

Eli Lilly

Global GMP Data Integrity Advisor – New Site Integration US, Indianapolis IN

Eli Lilly