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, alongside Data Management oversight and governance. This role also serves as the Site Data Leader and is responsible for managing direct reports and prioritizing work to achieve CSQA and Data Management objectives.

• Provide direct quality oversight to LP1 computer system validation (CSQA) and assist others in interpreting regulatory and corporate requirements as they relate to CSQA and data integrity/management.
• Guide and support efficient CSV and data integrity principles, process issues, and continuous improvement initiatives.
• Act 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 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 experience in 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. Critical situations may require additional support beyond this normal schedule.

The anticipated wage for this position is $123,000 - $180,400. Full‑time equivalent employees may also be eligible for a company bonus depending, in part, on company and individual performance.

Lilly is a proud 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.