Associate Director - Quality Assurance - Device Assembly
Eli Lilly and Company
August 26, 2026
On-site
Pleasant Prairie, WI
Operations
Position Overview
- Associate Director, Quality Assurance (QA) – Device Assembly (DA). Lead staffing, training, and QA oversight for start-up of combination product device assembly and operations at the Kenosha site.
Responsibilities
- Support Sr. Director, QA with site organization, Quality Management System implementation, and QA execution for Device Assembly and Packaging (DAP).
- Support safe work environment for the quality team.
- Develop operational readiness plan (quality processes and approval of DAP procedures).
- Build and lead a diverse, capable organization to ensure compliance with device assembly controls.
- Foster quality culture; maintain open communications and teamwork.
- Supervise/coach team; support performance management and fair/equitable environment.
- Delegate to achieve results; manage multiple priorities in fast-paced setting.
- Partner with production/design for 24/7 QA oversight.
- Support Operational Excellence and continuous improvement.
- Review/approve GMP documentation (protocols/reports, procedures, deviations, change controls, technical reports).
- Network with global DA sites; work cross-functionally for metrics and issue/deviation management.
- Set HR and business plan goals; participate in planning.
- Communicate project/production status.
- Lead inspection readiness and interact with Regulatory agencies during inspections.
Basic Requirements
- Bachelor’s in science/engineering/pharmaceutical field (or equivalent).
- 5+ years pharmaceutical leadership with QA experience.
- 5+ years supporting pharmaceutical manufacturing (preferably device assembly).
- On-site presence required.
Additional Skills/Preferences
- Quality Management Systems knowledge and regulatory requirements; inspection readiness.
- Facility/area start-up; equipment qualification & process validation.
- SAP/inventory systems; Manufacturing Execution Systems/electronic batch release.
- Automated material movement experience; deviation/change management (e.g., Veeva).
- Excellent communication; technical aptitude; technical writing; problem-solving.
Additional Information
- Flex hours; primary location Kenosha, WI; travel ~10–20%.
- Short-term assignment (6–9 months) at a Device Assembly and Packaging site before starting role.
Compensation/Benefits
- Anticipated wage: $123,000–$198,000. Eligible for company bonus and comprehensive benefits for eligible employees.
- Associate Director, Quality Assurance (QA) – Device Assembly (DA). Lead staffing, training, and QA oversight for start-up of combination product device assembly and operations at the Kenosha site.
Responsibilities
- Support Sr. Director, QA with site organization, Quality Management System implementation, and QA execution for Device Assembly and Packaging (DAP).
- Support safe work environment for the quality team.
- Develop operational readiness plan (quality processes and approval of DAP procedures).
- Build and lead a diverse, capable organization to ensure compliance with device assembly controls.
- Foster quality culture; maintain open communications and teamwork.
- Supervise/coach team; support performance management and fair/equitable environment.
- Delegate to achieve results; manage multiple priorities in fast-paced setting.
- Partner with production/design for 24/7 QA oversight.
- Support Operational Excellence and continuous improvement.
- Review/approve GMP documentation (protocols/reports, procedures, deviations, change controls, technical reports).
- Network with global DA sites; work cross-functionally for metrics and issue/deviation management.
- Set HR and business plan goals; participate in planning.
- Communicate project/production status.
- Lead inspection readiness and interact with Regulatory agencies during inspections.
Basic Requirements
- Bachelor’s in science/engineering/pharmaceutical field (or equivalent).
- 5+ years pharmaceutical leadership with QA experience.
- 5+ years supporting pharmaceutical manufacturing (preferably device assembly).
- On-site presence required.
Additional Skills/Preferences
- Quality Management Systems knowledge and regulatory requirements; inspection readiness.
- Facility/area start-up; equipment qualification & process validation.
- SAP/inventory systems; Manufacturing Execution Systems/electronic batch release.
- Automated material movement experience; deviation/change management (e.g., Veeva).
- Excellent communication; technical aptitude; technical writing; problem-solving.
Additional Information
- Flex hours; primary location Kenosha, WI; travel ~10–20%.
- Short-term assignment (6–9 months) at a Device Assembly and Packaging site before starting role.
Compensation/Benefits
- Anticipated wage: $123,000–$198,000. Eligible for company bonus and comprehensive benefits for eligible employees.