Senior QA Leader - Device Assembly & Compliance

BioSpace; Pleasant Prairie (WI); On-site; USD 123,000 - 198,000; Full time

Benefits offered by this job

Flex hours

Travel opportunities

Job summary

Lilly is actively growing its manufacturing footprint and seeks an Associate Director, Quality Assurance – Device Assembly in Kenosha, Wisconsin, to lead the QA group during startup and oversee QA for device assembly startup and packaging operations.

The role focuses on quality oversight of process development, qualification, validation, and GMP documentation, building a strong quality culture, and ensuring readiness for regulatory inspections.

Qualifications

• Bachelor's degree in a science, engineering, or pharmaceutical-related field.
• 5+ years’ experience in pharmaceutical leadership with QA experience, including leading or working effectively with a cross-functional group
• 5+ years’ experience directly supporting a pharmaceutical manufacturing operation (preferably device assembly operations)
• On-site presence required

Responsibilities

• Develop site quality operations plan and QMS implementation for Device Assembly and Packaging.
• Ensure a safe work environment and lead safety efforts for the QA team.
• Review GMP documentation including qualification/validation protocols and reports, procedures, deviations, and change controls for DA operations.
• Network with global and other DA sites to share best practices and knowledge.
• Define, lead and/or support inspection readiness activities for operations and interact with Regulatory agencies during inspections.

Skills

Quality Assurance

Regulatory Compliance

Leadership

GMP

Education

Bachelor's degree in science/engineering/pharma

Tools

SAP

Manufacturing Execution Systems

Electronic Batch Release

Veeva

Job description

Lilly is actively growing its manufacturing footprint and seeks an Associate Director, Quality Assurance – Device Assembly in Kenosha, Wisconsin, to lead the QA group during startup and oversee QA for device assembly startup and packaging operations.

The role focuses on quality oversight of process development, qualification, validation, and GMP documentation, building a strong quality culture, and ensuring readiness for regulatory inspections.