Associate Director, Quality Assurance - Parenteral Packaging

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana, with employees worldwide who aim to discover and bring life-changing medicines to those who need them, improve understanding and management of disease, and give back through philanthropy and volunteerism. We put people first and seek individuals determined to make life better for others.

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

The Associate Director, Quality Assurance (QA) – Parenteral Packaging, is responsible for staffing, training, and leadership of the quality assurance group supporting the start-up of combination product device and parenteral packaging operations at the Kenosha site. This role provides quality oversight of process development, operational readiness, qualification, and validation of the facility and its 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 ongoing operations 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 DAP.
• Support the site to ensure a safe work environment, including 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 Parenteral Packaging.
• Build a diverse and capable site organization to provide quality oversight and ensure compliance with area procedures and controls for labeling and packaging operations.
• Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation.
• Supervise, coach, and aid in development, performance management, and ensure a fair and equitable work environment.
• Engage the 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 continuous improvement of the operation.
• Review and approve GMP documentation including qualification/validation protocols and reports, procedures, deviations, technical reports, and change controls for parenteral packaging operations.
• Network with global and other parenteral packaging sites to understand best practices and share knowledge.
• Work cross-functionally with area process teams/flow teams 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 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 or equivalent experience.
• Minimum 5 years’ experience in pharmaceutical leadership with QA experience, including leading or collaborating with cross-functional teams.
• Minimum 5 years’ experience directly supporting a pharmaceutical manufacturing operation (preferably parenteral packaging operations).
• On-site presence required.

• Strong knowledge of Quality Management Systems and applicable regulatory requirements.
• Experience with regulatory inspection readiness and inspection execution.
• Experience…