Senior QA Leader - Device Assembly

100 Eli Lilly and Company; Wisconsin; On-site; USD 123,000 - 198,000; Full time

Benefits offered by this job

Flex hours

On-site in Kenosha, Wisconsin

Travel opportunities (10-20%)

Short-term assignment (6-9 months)

Job summary

Lilly is seeking an Associate Director, Quality Assurance (QA) – Device Assembly (DA) to lead a QA team at the Kenosha, Wisconsin site. The role includes staffing, training, and building a strong quality culture while ensuring robust oversight of process development, qualification and validation.

On-site presence and cross-functional collaboration are essential. You will work with operations, design, and regulatory to ensure 24/7 quality oversight, inspection readiness, and compliant GMP

Qualifications

• Bachelor's degree in a science, engineering, or pharmaceutical-related field.
• Minimum 5 years’ experience in pharmaceutical leadership with QA experience.
• On-site presence required.

Responsibilities

• Lead QA group supporting startup of device assembly and packaging.
• Oversee qualification/validation of facility and equipment.
• Ensure inspection readiness and regulatory compliance.
• Develop and implement Quality Management System elements at the site.
• Coach and develop staff; manage priorities in a fast-paced environment.

Skills

Quality leadership

Regulatory knowledge

Cross-functional collaboration

Quality Systems

Inspection readiness

Process validation

Education

Bachelor's degree in science/engineering/pharma

Tools

SAP

Job description

Lilly is seeking an Associate Director, Quality Assurance (QA) – Device Assembly (DA) to lead a QA team at the Kenosha, Wisconsin site. The role includes staffing, training, and building a strong quality culture while ensuring robust oversight of process development, qualification and validation.

On-site presence and cross-functional collaboration are essential. You will work with operations, design, and regulatory to ensure 24/7 quality oversight, inspection readiness, and compliant GMP