Associate Director - CSV Lead

Company: Eli Lilly and Company
Location: Indianapolis
Posted on: July 16, 2025

Job Description:

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. This is an opportunity you don’t want to miss! Lilly is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. Lilly is investing to create a new state-of-the-art manufacturing sites. The brand-new facilities will utilize the latest technology for API Manufacturing and will include several platforms including Peptides, Small Molecules and Oligonucleotides Drug Substance Manufacturing. This is an exciting once-in-a-lifetime opportunity to help build and operate a new site. The sites will be built using the latest high-tech equipment, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment. What You’ll Be Doing : You will be part of Tech@Lilly MQ (Manufacturing and Quality), an organization that drives manufacturing operational excellence and productivity efforts through utilization of technology. Tech@Lilly MQ strives to enable the making of medicine “with safety first and quality always”. The CSV Lead will provide technical leadership across the different site and global IT groups focused on Computer System Validation Strategies, external regulations, industry best practices, policies and procedures governing the process to validate, maintain and retire new and existing computer systems. This role will be responsible for managing and maintaining the process architecture of global strategies, policies and procedures to ensure that all solutions deployed are developed and implemented according to corporate policies and regulatory requirements. This role will collaborate within the Lilly Tech@Lilly and Quality organizations and externally with industry forums and standard to ensure the state of compliance of computer systems. This position is vital for ensuring all programs are aligned with the overall Strategy for New API facilities and deliver desired outcomes efficiently and within budget. How You’ll Succeed: Oversight of computer systems validation strategies and activities across new API facilities, including the review and approval of all documentation issued to support the validation/qualification of non-GMP and GMP systems, as appropriate. Define the risk management approach to be followed by new API facilities. Define the inspection readiness approach for new API facilities. Acts as the primary contact and has principal responsibility for supporting all internal and external CSV related audits and privacy related inspections, working in collaboration with Computer Systems Quality Assurance on GMP related systems. Also responsible for privacy initiatives to ensure that all computer-based systems comply with internal and external privacy policies and requirements. Support Data Integrity readiness for regulatory authority inspections and if required, effectively represent the company during regulatory audits through interaction/ discussion with regulatory officials related to data management and integrity. Ensure we have consistent and reusable CSV strategies and artifacts across all New API facilities. Participate in business plan activities and in appropriate site governance and steering teams. Create a standard approach for GMP designation and testing requirements for site systems. Must have working understanding of compatibility, integration, interoperability, stability, scalability and usability of products/services being implemented to ensure validation activities cover all requirements. Must ensure security and privacy risks are considered in the design and testing of IT systems. Basic Requirements: Bachelor’s Degree in Business Administration with Major in Information Systems, Computer Science or Programming; or BS Engineering (Computer, Electrical, Industrial, Mechanical, Chemical) or equivalent. 10 years experience working in a regulated industry (i.e. GMP) and strong understanding of quality processes in IT applying to manufacturing and distribution. Experience in supporting regulatory audits; both readiness and audit support. Hands on experience in execution Manufacturing and/or Lab systems CSV testing in the shop floor. ? Additional Preferences Experience: Experience in Lab systems and instrument CSV Leadership Skills: Proven leadership experience in managing cross-functional teams. Industry Engagement : Active participation in industry forums and standards organizations. Strong experience managing multiple concurrent initiatives and projects with aggressive timelines. Ability to communicate effectively in written and verbal form (in English), with proven success at delivering key messages to both management and peers across multiple business functions Highly motivated, enthusiastic to learn and share ideas and solutions effectively with management and colleagues. Strong collaboration with colleagues at all levels. Demonstrated courage & integrity. Demonstrated success in influencing without authority. Ability to take initiative, to be assertive, to lead by example and to build high-quality relationships. Highly flexible, adapting to changes in priorities, requirements and processes is required. Demonstrated ability to write technical documents, develop business presentations and effectively communicate concepts to a wide range of personnel including senior leadership. Strong knowledge and technical expertise in areas of cGMPs, processes, production practices, and quality systems. Recognized understanding of regulations governing CSV and data integrity. Other Information: Role is Monday through Friday and based on-site. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hour and / or off-hour work may be required. Position will be based out of Indianapolis Indiana. Up to 50% of Business Travel time. Due to the different locations of the New Facilities, extended duration business travel may be required base on business needs. 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 ( https://careers.lilly.com/us/en/workplace-accommodation ) 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 $123,000 - $180,400 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

Keywords: Eli Lilly and Company, Noblesville , Associate Director - CSV Lead, Engineering , Indianapolis, Indiana