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 also responsible for managing the development of direct reports and prioritizing work appropriately to implement LP1, Computer System Quality Assurance (CSQA) and Data Management objectives.

• Provide direct quality oversight to LP1 computer system validation (CSQA) and assist others in interpretation of regulatory and corporate requirements as it relates to CSQA and data integrity/management.
• Provide quality guidance, technical support and recommendations to efficient CSV and data integrity principles, process issues and continuous improvement initiatives.
• Work as the LP1 Site Data Leader.
• Work 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 aspects of QA support including CSV/Data Management understanding, problem solving, project management and deviation investigation/resolution.

• BS or higher degree in Engineering/Science, Computer Science, Information Technology or related field.
• 5+ years in pharmaceutical manufacturing, with specific experiences to computer system validation, and data integrity principles.
• 2+ years of direct people leadership.

• Previous facility or area start up experience
• Previous 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

The normal schedule for this position is Monday‑Friday, 8 hours/day. However, critical situations may require additional support beyond this normal schedule.

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 () 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.

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.