Senior Manager of Quality Assurance

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life‑changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

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. Our 39,000 employees around the world work to discover and bring life‑changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.

We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Sr. Manager Quality Assurance (QA) Parenteral is responsible for the staffing, training, and leadership of the quality assurance group supporting the project/expansion delivery, process development, operational readiness, start up, and validation/qualification of the parenteral process including dispensing, equipment preparation, formulation, filling and visual inspection.

The Sr. Manager will help build a strong quality culture and lead the QA team for oversight and support of the ongoing operation as well as site inspection readiness and execution.

On Site Shift

Schedule:

Monday to Friday 4pm to 12:30am Subject to change as needed

Direct Reports:
Night shift team 6pm to 6am

• The Night Shift Sr. Manager, Quality Assurance, will support the start‑up and routine operation of the QA organization overseeing Parenteral operations at Lilly's Kenosha, Wisconsin pharmaceutical manufacturing site. Responsibilities include technical and administrative leadership, as well as project management.
• Serve as technical resource to review and approve technical documents
• Network with cross‑functional technical project delivery team to ensure equipment and systems comply with quality requirements and are implemented with a Quality by Design framework
• Work with the Associate Director, Quality Assurance to support the development of the vision, strategy and quality culture for the overall site quality assurance organization with focus on the formulation, filling and visual inspection programs
• Support initial recruiting, build capability, for a diverse leadership and quality assurance staff to support qualification, validation and routine production
• Manage a team of up to approximately 8-12 direct reports
• Support the site to ensure a safe work environment including supporting and leading safety efforts for your team
• Support the development of the overall site operational readiness plan including development of quality processes and approval of operational procedures and controls
• Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group
• Supervise, coach, and aid in employee development and performance management; ensure a fair and equitable work environment
• Review and approve GMP documentation including procedures, deviations, technical reports, change controls, etc.
• Network with global and other parenteral sites to understand best practices and share knowledge
• Work cross‑functionally with the…