Sr./Principal Associate - Data Management QA

Eli Lilly - Lebanon, IN

Full-time

Lebanon, IN

Chemical Manufacturing

About the position

The Data Management QA Representative at Lilly will play a crucial role in establishing and maintaining Quality and Data Integrity principles within the new GMP manufacturing facility in Lebanon, IN. This position involves collaborating with cross-functional teams to ensure compliance with regulatory standards and to support the startup of the facility's operations. The successful candidate will be responsible for developing training programs, mentoring staff, and driving continuous improvement initiatives related to data management and integrity.

Responsibilities

• Understand customer, company, and Quality priorities, and support implementation goals.
• Provide linkages to partner organizations with CSV including Automation, Site Equipment Verification, Business QA, and site CSQA persons.
• Mentor others in data management-related roles.
• Provide consulting and interpretation on Corporate Computer Systems/Data Integrity standards and practices as implemented at the LP1 facility.
• Provide cross-functional technical leadership in the event of serious quality-related issues with data management.
• Monitor current state of inspection-readiness and escalate issues appropriately.
• Promote common process and best practice across functions.
• Identify systemic issues and trends across functions and drive improvement activity.
• Understand the external environment/best practices and bring external learning back to Lilly.

Requirements

• Bachelor's degree in Computer Science, Engineering, Life Sciences, or a technology-related field OR 10+ years of relevant experience
• 1+ years of experience in Automation/QC Labs/IT, Quality, computer system validation or data integrity in the pharmaceutical industry

Nice-to-haves

• Direct experience with Computer Systems Validation (GAMP5) and data integrity basic principles (ALCOA+)
• Previous experience in GMP production environments
• Demonstrated strong oral and written communication skills
• Strong interpersonal interaction skills
• Proven ability to influence quality peers, IT SMEs, and upper management
• Previous experience in Business Quality Assurance and Automation

Benefits

• Equal opportunity employer
• Employee resource groups for support and development
• Accommodations for individuals with disabilities