Associate Director, QA – Device Assembly

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

Benefits offered by this job

Flex hours possible

Travel opportunities (10-20%)

Job summary

Lilly is seeking an Associate Director, Quality Assurance (QA) – Device Assembly (DA) to lead the QA team at the Kenosha site, overseeing process development, qualification, and validation efforts for device assembly and packaging. You will drive quality culture and ensure inspection readiness across operations.

Responsibilities include building a capable site QA organization, collaborating with manufacturing, and ensuring compliance with GMP and regulatory requirements.

Qualifications

• Minimum 5 years’ experience in pharmaceutical leadership with QA experience, including leading or working effectively with a cross-functional group
• Minimum 5 years’ experience directly supporting a pharmaceutical manufacturing operation (preferably device assembly operations)
• On-site presence required

Responsibilities

• Support the Sr. Director, QA, in the development of the site organization, creation of the Quality Management System implementation plan, and execution of site quality operations in Device Assembly and Packaging (DAP).
• Support the site to ensure a safe work environment including supporting and leading safety efforts for the quality team.
• Support the development of the overall site operational readiness plan including development of quality processes and approval of operational procedures for DAP.
• Build a diverse and capable site organization to provide quality oversight and ensure compliance with area procedures and controls for device assembly.
• Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group.
• Supervise, coach, and aid in development, performance management, ensure a fair and equitable work environment.
• Engage team and delegate to achieve results through others to deliver according to plan.
• Manage multiple priorities in a fast-paced environment and deliver in accordance with established due dates.
• Demonstrate flexibility with quick response as priorities change or issues arise.
• Partner with production and design organization to ensure 24/7 Quality oversight and support.
• Engage and support Operational Excellence initiatives for monitoring performance and continuously improving the operation.
• Review and approve GMP documentation including qualification/validation protocols and reports, procedures, deviations, technical reports, change controls, for DA operations.
• Network with global and other DA sites to understand best practices, share knowledge.
• Work cross-functionally with the area process teams/flow team for metrics reviews, operational support, and issue/deviation management.
• Set area human resource and business plan goals.
• Participate in tactical and strategic business planning.
• Communicate on project and production status.
• Define, lead and/or support inspection readiness activities for operations and interact with Regulatory agencies during inspections.

Skills

Quality Management Systems

Regulatory readiness

Cross-functional leadership

Equipment qualification

GMP documentation

Interpersonal communication

Problem-solving

Training & mentoring

Education

Bachelor's degree in a science, engineering, or pharmaceutical-related field of study or equivalent experience

Tools

SAP

Manufacturing Execution Systems

Job description

Lilly is seeking an Associate Director, Quality Assurance (QA) – Device Assembly (DA) to lead the QA team at the Kenosha site, overseeing process development, qualification, and validation efforts for device assembly and packaging. You will drive quality culture and ensure inspection readiness across operations.

Responsibilities include building a capable site QA organization, collaborating with manufacturing, and ensuring compliance with GMP and regulatory requirements.