Associate Director - Quality Assurance - Device Assembly

Position Overview

Associate Director, Quality Assurance (QA) – Device Assembly (DA). Lead staffing, training, and QA oversight for start-up of combination product device assembly and operations at the Kenosha site (process development, operational readiness, qualification, and validation). Build site quality culture and lead the QA team for ongoing operation and inspection readiness.

• Support Sr. Director, QA in site organization, Quality Management System implementation, and execution for Device Assembly and Packaging (DAP).
• Support safe work environment and lead safety efforts for the QA team.
• Develop operational readiness plan, quality processes, and approve DAP operational procedures.
• Build capable QA organization to ensure compliance with device assembly procedures and controls.
• Foster quality culture (open communications, teamwork, employee participation).
• Supervise/coach/mentor, performance manage, and support fair/equitable work environment.
• Manage priorities in fast-paced environment; demonstrate flexibility as issues change.
• Partner with production and design for 24/7 quality oversight.
• Support Operational Excellence and continuous improvement.
• Review/approve GMP documentation (qualification/validation protocols/reports, procedures, deviations, technical reports, change controls).
• Network with global/DA sites; work cross-functionally for metrics, operational support, issue/deviation management.
• Set HR and business plan goals; participate in business planning.
• Communicate project/production status.
• Lead inspection readiness and interact with Regulatory agencies.

• Bachelor’s degree in science/engineering/pharma or equivalent experience.
• 5+ years pharmaceutical leadership with QA experience (cross-functional).
• 5+ years supporting pharmaceutical manufacturing (preferably device assembly).
• On-site presence required.

• Quality Management Systems and regulatory knowledge; inspection readiness/execution.
• Facility/area start-up; equipment qualification and process validation.
• SAP/inventory systems; MES/electronic batch release.
• Automated combination products/packaging/warehouse; automated material movement.
• Deviation/change management systems (e.g., Veeva); strong communication and technical writing.

• Primary location:
  Kenosha, Wisconsin. Flex hours possible.
• Travel: ~10–20%.
• Short Term Assignment (6–9 months) at Device Assembly & Packaging site prior to role start.