Associate Director - Quality Assurance - Device Assembly

Associate Director, Quality Assurance (QA) – Device Assembly (DA)

Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future. As a result, Lilly is looking for experienced quality assurance leaders to support our growth in Kenosha County, Wisconsin. This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies.

The Associate Director, Quality Assurance (QA) – Device Assembly (DA), is responsible for staffing, training, and leadership of the quality assurance group supporting the start-up of combination product device assembly and operations at the Kenosha site. This individual is responsible for quality oversight of process development, operational readiness, qualification, and validation of the facility and its associated equipment. The Associate Director will help build a strong quality culture at the site and lead the QA team ensuring robust oversight and support of the ongoing operation as well as the site inspection readiness agenda.

• 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.

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

• Strong knowledge of Quality Management Systems and applicable regulatory requirements
• Previous regulatory inspection readiness and inspection execution experience
• Previous facility or area start up experience
• Previous equipment qualification and process validation experience
• Previous experience with SAP or other inventory management systems
• Previous experience with highly automated combination products, packaging, and warehouse operations
• Previous experience with Manufacturing Execution Systems and electronic batch release
• Previous experience with automated material movement (central palletizing operation, automated warehousing)
• Previous experience with deviation and change management systems such as Veeva
• Excellent interpersonal, written and oral communication skills
• Strong technical aptitude and ability to train and mentor others
• Demonstrated technical writing skills
• Demonstrated problem-solving and decision-making skills

Additional Information:

• Flex hours possible
• Primary location is Kenosha, Wisconsin
• Ability to travel (approximately 10-20%)
• Ability for Short Term Assignment (6-9 Months) in a Device Assembly and Packaging site prior to starting the role