Eli Lilly is seeking an Associate Director of Quality Assurance for Parenteral Packaging at its Kenosha, Wisconsin site. The role involves leading a quality assurance team, ensuring compliance with regulatory standards, and supporting the startup of new manufacturing operations
Job Summary
The Associate Director will lead the Quality Assurance group supporting the start-up of combination product device and parenteral packaging operations at the Kenosha site.
This role requires overseeing process development, operational readiness, qualification, and validation while ensuring compliance with GMP regulations.
Candidates must be prepared to engage in a short-term assignment at a Device Assembly and Packaging site prior to starting the primary role.
Matching Summary
Match Score: 85
Eli Lilly is seeking an Associate Director of Quality Assurance for Parenteral Packaging at its Kenosha, Wisconsin site. The role involves leading a quality assurance team, ensuring compliance with regulatory standards, and supporting the startup of new manufacturing operations.
Salary
Base: $123,000 - $198,000; Bonus/Equity: Company bonus eligible; Benefits: Comprehensive program including 401(k), medical, dental, vision, and paid time off
Skills & Requirements
Must-have
5 years pharmaceutical QA leadership experience
Parenteral packaging manufacturing support
GMP documentation review and approval
Facility qualification and validation oversight
Inspection readiness and regulatory interaction
Nice-to-have
Experience with highly automated combination products
Knowledge of SAP or inventory management systems
Background in Manufacturing Execution Systems
Experience with deviation and change management systems like Veeva
Ability to foster strong quality culture
Key Requirements
Bachelor's degree in science, engineering, or pharmaceutical field
Minimum 5 years pharmaceutical leadership experience
Minimum 5 years directly supporting pharmaceutical manufacturing operations