Associate Director, QA - Device Assembly Startup

Regulatory Jobs; Pleasant Prairie (WI); Sur place; USD 123 000 - 198 000; Plein temps

Avantages offerts par ce poste

Flex hours possible

Travel 10-20%

Short-term assignment (6-9 months)

Résumé du poste

Lilly is expanding its manufacturing footprint and seeks an Associate Director, QA - Device Assembly in Kenosha, Wisconsin. You will staff and lead the QA group supporting start-up activities, oversee qualification/validation of the facility and equipment, and drive a robust quality culture across operations.

The role requires on-site presence, cross-functional collaboration, and leadership in inspections readiness and regulatory interactions.

Qualifications

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

Responsabilités

• Support development of site organization and Quality Management System implementation plan.
• Ensure safe work environment and lead safety efforts for the quality team.
• Approve operational procedures for Device Assembly and Packaging (DAP).
• Build a diverse and capable site organization for quality oversight and compliance.
• Foster a strong quality culture and promote teamwork and participation.
• Supervise, coach, and develop staff; manage performance and fairness.
• Manage multiple priorities to meet established due dates.
• Partner with production and design to ensure 24/7 QA oversight.
• Lead inspection readiness activities and liaise with regulatory agencies.

Connaissances

Quality leadership

Quality Management Systems

Regulatory inspection readiness

Facility start-up experience

SAP or inventory systems

MES / electronic batch release

Deviation & change management (Veeva)

Interpersonal communication

Formation

Science/engineering/pharma degree or equivalent

Outils

SAP

Veeva

MES

Description du poste

Lilly is expanding its manufacturing footprint and seeks an Associate Director, QA - Device Assembly in Kenosha, Wisconsin. You will staff and lead the QA group supporting start-up activities, oversee qualification/validation of the facility and equipment, and drive a robust quality culture across operations.

The role requires on-site presence, cross-functional collaboration, and leadership in inspections readiness and regulatory interactions.