Sr. Manager - QA Incoming Batch Disposition

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 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.

The Quality Assurance Manager is responsible for support of the quality disposition of materials, semi‑finished and finished goods for the RTP production site. The role will help build a strong quality culture and be responsible for oversight and support of the ongoing operation as well as site inspection readiness and execution. The Manager reports to the Associate Director‑Materials QA.

• Support the site to ensure a safe work environment including supporting and leading safety efforts for your team
• Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group
• Support the development of the overall site operational readiness plan including development of quality processes and approval of operational procedures
• Build a diverse and capable organization to support quality oversight, and ensure compliance with area procedures and controls for material and product record review and release
• Drive operational excellence in disposition process through data analysis to reduce variability and shift performance cycle times to align with supply delivery targets
• Supervise, coach, and aid in development, performance management, ensure a fair and equitable work environment
• Review and approve GMP documentation including procedures, deviations, technical reports, change controls, etc.
• Support site inspection readiness and execution
• Work cross‑functionally with the area process teams for metrics reviews, operational support, and issue / deviation management
• Interact with the project and functional areas to coordinate activities to support the overall project and site schedule
• Setting of area human resource and business plan goals

• Bachelor's degree in a science, engineering, computer, pharmaceutical related field of study or equivalent experience
• Previous experience working in the pharmaceutical industry in QA/QC roles
• Previous management or leadership experience including leading or working effectively with a cross functional group
• Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H‑1B or TN status) for this employment position.

• Strong knowledge of Quality Management Systems and applicable regulatory requirements
• Previous regulatory inspection readiness and inspection execution experience
• Previous experience directly supporting a large manufacturing and warehouse operation
• Previous experience with highly automated manufacturing processes
• Previous experience with Manufacturing Execution Systems and electronic batch release
• Excellent interpersonal, written and oral communication skills
• Strong technical aptitude and ability to train and mentor others
• Ability to work 8‑hour days – Monday through Friday
• Ability to work overtime as required
• Ability to travel up to 10% to Indianapolis, IN for meetings and coordination with global regulatory organizations.
• Previous facility or area start up experience
• Previous experience with SAP or other inventory management systems
• Previous experience with deviation and change management systems including Trackwise
• Previous experience with Lean, Six Sigma or other known improvement methodology

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