Associate Director, QA — Device Assembly Start-Up

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

Benefits offered by this job

Flex hours

On-site primary location Kenosha, WI

Travel opportunities (10-20%)

Job summary

Lilly is expanding its quality assurance leadership for device assembly at the Kenosha site in Wisconsin. The Associate Director, QA – Device Assembly, will staff and mentor the QA group, oversee process development, qualification, and validation, and ensure inspection readiness and regulatory compliance.

This role emphasizes building a robust quality culture, cross-functional collaboration, and strong oversight of GMP documentation while supporting a 24/7 operation and 10–20% travel.

Qualifications

• Bachelor's degree in science, engineering, or pharmaceutical-related field or equivalent experience.
• Minimum 5 years’ experience in pharmaceutical leadership with QA experience, including cross-functional collaboration.
• Minimum 5 years’ experience directly supporting pharmaceutical manufacturing operations (device assembly preferred).
• On-site presence required.

Responsibilities

• Lead QA team during start-up of device assembly and packaging (DAP).
• Develop and approve QA processes, qualification, validation, and inspection readiness.
• Maintain GMP documentation and ensure compliance with area procedures and controls.
• Foster a strong quality culture and open communication across teams.
• Collaborate with production and design to ensure 24/7 QA oversight and support.
• Manage multiple priorities in a fast-paced environment to meet due dates.

Skills

QA Leadership

Cross-functional Leadership

Regulatory Knowledge

GMP Documentation

Quality Systems

Device Assembly Operations

Education

Bachelor's degree in science/engineering/pharma

Tools

SAP

Manufacturing Execution Systems (MES)

Veeva

Electronic Batch Release systems

Job description

Lilly is expanding its quality assurance leadership for device assembly at the Kenosha site in Wisconsin. The Associate Director, QA – Device Assembly, will staff and mentor the QA group, oversee process development, qualification, and validation, and ensure inspection readiness and regulatory compliance.

This role emphasizes building a robust quality culture, cross-functional collaboration, and strong oversight of GMP documentation while supporting a 24/7 operation and 10–20% travel.