Associate Director - Quality Assurance - Device Assembly

Role: Associate Director, Quality Assurance – Device Assembly at Lilly, focusing on supporting manufacturing startup and operational readiness for combination product device assembly. Responsibilities: lead QA staffing, training, oversee process development, validation, and qualification; develop and implement site quality systems; ensure inspection readiness and compliance with GMP and regulatory standards; foster a quality culture and build a capable team; collaborate cross-functionally with production, design, and global QA teams; support deviation, change management, and continuous improvement initiatives. Requirements: Bachelor's in science, engineering, or related field; at least 5 years’ pharmaceutical QA leadership experience supporting manufacturing operations, preferably device assembly; strong knowledge of QMS, GMP, regulatory inspection readiness, and equipment qualification; on-site presence required. Preferred: experience with highly automated combination products, SAP, MES, automated warehousing, and Veeva systems; excellent communication, technical writing, and problem-solving skills. High-Value: combination product manufacturing, device assembly, GMP compliance, regulatory inspections, facility startup, process validation, automated manufacturing systems. Work Setup: on-site in Kenosha, Wisconsin; travel 10-20%; possible short-term assignments prior to role start.