Eli Lilly UK is seeking a Quality Assurance - Computer Systems and Data Lead for their new facility in Lebanon, Indiana. The ideal candidate will have extensive experience in quality assurance, particularly in computer systems validation and data analytics, to support the startup of a cutting-edge manufacturing site focused on advanced therapeutic medicinal products
Job Summary
This role is responsible for QA technical oversight including approvals, cross-functional decision making and site level mentoring for CSQA staff.
The Associate Director, Quality Assurance - Computer Systems & Data Leader, will initially serve as the Computer Systems Quality Assurance Lead for the design and start-up phases for the new new facility in Lebanon, Indiana, with primary focus on the manufacture of Advanced Therapeutic Medicinal Products (ATMPs) such as gene therapies.
This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to design, commission, start up, and maintain the facility for both clinical and commercial supply.
Matching Summary
Match Score: 85
Eli Lilly UK is seeking a Quality Assurance - Computer Systems and Data Lead for their new facility in Lebanon, Indiana. The ideal candidate will have extensive experience in quality assurance, particularly in computer systems validation and data analytics, to support the startup of a cutting-edge manufacturing site focused on advanced therapeutic medicinal products.
Salary
Base: $65,250 - $169,400; Bonus/Equity: Company bonus eligible; Benefits: Comprehensive benefit program
Skills & Requirements
Must-have
Computer Systems Validation (CSV)
Data Integrity Strategies
GMP Data Controls
Advanced Therapeutic Medicinal Products (ATMPs)
Quality by Design (QbD)
Quality Risk Management (QRM)
Nice-to-have
Strong quality culture
Leverage technology for digitalization
Analytics for competitive advantage
Cross-functional team mentoring
Facility startup experience
Key Requirements
Bachelor's degree in engineering or computers preferred
5+ years in pharmaceutical QA roles
3+ years in Computer System Quality Assurance/Validation