Associate Director – QA – LAPI

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.  Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN.  This facility is Lilly’s largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities.  This is a unique opportunity to be a part of the site team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, the facility, and the culture to enable a successful startup into GMP manufacturing operations.

Brand Description: The Associate Director – QA is a partner with the Sr. Director – QA in ensuring that operations have robust quality oversight. The Associate Director – QA is primarily responsible for the productivity and development of the QA employees, the quality of the product/results, oversight of manufacturing and support operations and overall customer service.  It is expected that the Associate Director will oversee the department’s performance, resolution of quality issues, and regulatory compliance. Key Objectives/Deliverables: Provide coaching/feedback to and develop QA employees. Utilize Human Resources tools to ensure that the right individuals are in the right job (e.g., Performance Management, Merit Delivery, Talent Assessment, Succession Planning and Staffing). Participate in organizational planning. Provide input into the business plan and ensure conformance to department budget for area of responsibility. Exhibit cross-functional influence. Maintain and improve quality systems. Approve deviations, procedures, protocols, and change controls. Develop and maintain processes that support inspections and audits; prepare individuals to interact with auditors and inspectors. Participate in self-assessments and regulatory agency inspections. Ensure internal and external quality and supply commitments are met. Provide quality management oversight for API manufacturing, laboratories, and warehouses. Investigate complaints. Manage the creation, revision, and maintenance of cGMP documents (e.g., job aids, procedures, forms, job descriptions). Provide oversight and review of changes to the Global Quality Standards and ensure local implementation of changes. Network with other sites regarding new or current quality systems.

BS or equivalent in a scientific field or engineering. 5+ years in CGMP Manufacturing. Additional Preferences: Knowledge of cGMPs. Experience in Manufacturing, QC, QA, Technical Services, Engineering or Regulatory Affairs Leadership Previous experience supervising/leading people. Demonstrated strong written and verbal communications skills. Strong attention to detail. Understanding of statistical tools and analysis. Excellent interpersonal skills and networking skills. Ability to organize and prioritize multiple tasks. Demonstrated strong problem solving and analytical thinking skills. Ability to influence diverse groups. Demonstrated understanding of computer applications. Other Information: Must complete Learning Plan for Associate Director – QA – LAPI. No certifications required. Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE. Must support 24 hour/day operations. Some travel may be required. Lilly is dedicated