Associate Director​/Director - 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, self‑less 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.

The QA Associate Director/Director is responsible for providing leadership, daily support and oversight to qualify and deliver a multi‑shift GMP operation capable of producing both commercially approved and late stage investigational aseptically produced radioligand compounds. This position is also responsible for managing the activities of Quality Assurance personnel with respect to record review and release, quality oversight of microbiology and quality control labs, regulatory requirements, procedural interpretation and training, regulatory agency inspections and maintenance of inspection readiness.

This role may also support external manufacturing (EM) responsibilities, which includes collaboration partner oversight and lifecycle management.

• Establish clear Quality Assurance roles and responsibilities and assure QA has proper accept/reject authority

• Establish governance mechanisms to lead staff, assure inter‑connectedness between functions, adequate communication, and escalation per local and global procedures

• Assure the Quality Management System is designed, executed, and reviewed for its performance for areas of responsibility, according to global standards and procedures. Lead integration efforts to establish alignment and act as an SME or contact with Global Quality Systems. Develop local procedures and tools for site specific controls and/or unique radiopharmaceutical characteristics.

• Assure controls are established, traceability, and joint team collaboration for the initiation of deviation events. Verify the adequacy of deviation events, the depth of root cause investigations to derive a proper correction or corrective action according to global procedures

• Support the Site Leadership Team in identifying annual objectives, improvement plans, and solutions

• Partner with Technical Services in the design and qualification of new or changing manufacturing processes, their qualification/re‑qualification

• Maintain a safe work environment; actively support all HSE Site safety goals/initiatives

• Foster a quality culture that promotes open communication, participation and teamwork

• Supervise, coach, and aid in employee development and performance management; ensure a fair and equitable work environment

• Apply formal technical knowledge of GMP quality systems and aseptic radioligand operations, with an understanding of how Site Quality contributes to the broader business goals

• Make decisions within established Quality, regulatory, and global procedural guidelines, exercising sound judgment across release, deviation, and inspection‑readiness activities

• Influence internal and external customers, regulators, and site/global management; collaborate with direct reports and peers to drive impact across close working teams

• Identify and solve a range of organizational, operational, and technical quality challenges affecting site operations, product release, and compliance posture

• Hold management responsibility for broader Quality Assurance teams, including oversight of record review and release, micro/QC labs, and inspection readiness

• Cont…