QA Leader — Device Assembly & Compliance

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

Benefits offered by this job

Company bonus

401(k) plan

Pension plan

Vacation benefits

Medical benefits

Flexible benefits

Life insurance

Well-being programs

Job summary

Lilly is growing its manufacturing footprint and seeks an experienced Associate Director, Quality Assurance – Device Assembly in Kenosha, WI. This role leads QA for start-up device assembly/packaging and oversees process development, qualification, and validation to ensure site readiness and regulatory compliance.

The position drives quality culture, staffing, and training, partnering with production and design to ensure 24/7 quality oversight and inspection readiness.

Qualifications

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

Responsibilities

• Support the Sr. Director, QA, in developing site organization and Quality Management System implementation plan.
• Ensure safe work environment and lead safety efforts for the quality team.
• Develop site operational readiness, quality processes, and approval of DAP procedures.
• Build a capable QA organization to provide oversight and ensure compliance.
• Promote a strong quality culture and open communication within the team.
• Supervise, coach, and support staff development and performance management.
• Engage team to achieve results and manage multiple priorities to deadlines.
• Provide 24/7 QA oversight with production/design teams and support Operational Excellence initiatives.
• Review GMP documents and interact with Regulatory agencies during inspections.

Skills

Quality leadership

Cross-functional leadership

Regulatory readiness

Leadership of QA teams

Operational readiness

Staff development

Education

Bachelor's in science/engineering/pharma

Tools

SAP

Job description

Lilly is growing its manufacturing footprint and seeks an experienced Associate Director, Quality Assurance – Device Assembly in Kenosha, WI. This role leads QA for start-up device assembly/packaging and oversees process development, qualification, and validation to ensure site readiness and regulatory compliance.

The position drives quality culture, staffing, and training, partnering with production and design to ensure 24/7 quality oversight and inspection readiness.