Associate Director Data and Systems QA

Job Position Overview The Quality Assurance Associate Director of Data and Systems QA plays a critical role in developing and maintaining the quality and regulatory compliance of our computer systems at LP1, along with the Data Management oversight and governance at the site. This person is also the Site Data Leader. The Associate Director is responsible for managing the development of direct reports and prioritizing work to implement LP1, Computer System Quality Assurance (CSQA) and Data Management objectives. Responsibilities Provide direct quality oversight to LP1 computer system validation (CSQA) and assist others in interpreting regulatory and corporate requirements related to CSQA and data integrity/management. Offer quality guidance, technical support, and recommendations for efficient CSV and data integrity principles, process issues, and continuous improvement initiatives. Serve as the LP1 Site Data Leader. Collaborate with cross‑functional teams to implement QA objectives. Prepare for and participate in internal and external regulatory inspections. Coach and mentor Data and Systems QA representatives in QA support, CSV/Data Management, problem solving, project management, and deviation investigation/resolution. Basic Requirements BS or higher degree in Engineering/Science, Computer Science, Information Technology or related field. 5+ years in pharmaceutical manufacturing with specific experience in computer system validation and data integrity principles. 2+ years of direct people leadership. Additional Skills/Preferences Previous facility or area start‑up experience. Experience in QA, QC Science/Engineering, or Computer Science and Technology. Prior work with cGMPs, external regulations, and inspections. Strong knowledge of Computer System Validation, Data Integrity/Management, Quality Management Systems, and applicable regulatory requirements. Demonstrated problem‑solving and decision‑making skills. Strong technical aptitude and ability to train and mentor others. Additional Information The normal schedule for this position is Monday‑Friday, 8 hours/day. Critical situations may require additional support beyond this normal schedule. Lilly is dedicated to helping individuals with disabilities engage in the workforce. If you require accommodation to submit a resume for a position at Lilly, complete the accommodation request form ( for further assistance. 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. Compensation & Benefits 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 are also eligible for a company bonus (depending, in part, on company and individual performance). Lilly offers a comprehensive benefit program to eligible employees, including 401(k) participation, pension, vacation benefits, medical, dental, vision, prescription drug benefits, flexible benefits such as healthcare and dependent day‑care flexible spending accounts, life and death insurance, certain time‑off and leave of absence benefits, and well‑being benefits such as employee assistance programs, 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. Lilly’s compensation practices and guidelines will apply regarding any promotion or transfer of Lilly employees. #J-18808-Ljbffr BioSpace