Director/Senior Director, Global Process Owner – Sterility Assurance QMS

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.

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.

Company Overview:

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.

Organization Overview:

Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is working to build a stronger Sterility Assurance function and capability to provide increased technical capacity across the network.

Position Brand Description:

The Director/Senior Director, Global Process Owner for Sterility Assurance, as a leader within the Technical Service, Manufacturing Sciences, Sterility Assurance team, will establish and maintain the global quality system procedural requirements for a Level 2 Process related to Aseptic Processing controls inclusive of Aseptic Process Simulations, Barrier System Management, Cleaning and Disinfection, Aseptic Technique, and Aseptic Training. They will provide strategic oversight and expertise for global Aseptic Processing Programs, including Quality Management System Sterility Assurance standards, practices, business processes, implementation tools and associated IT systems. Additionally, the Global Process Owner will lead an Aseptic Processing Program Community of Practice, including Global Process Leads and Area Process Owners. They will lead key global projects and priorities within the Sterility Assurance Level 1 Program.

The Global Process Owner will consult with Lilly manufacturing facilities, Global and Site Quality and other functions to educate on the Sterility Assurance program requirements, and proactively ensure compliance of the Lilly Sterility Assurance program with various country agency standards, industry trends and scientific principles.

Key Objectives/Deliverables

The Director/Senior Director, Global Process Owner for Sterility Assurance Level 2 Processes is responsible to:

• Establish and maintain the global quality system for Aseptic Processing Programs to drive standardization globally.
• Own the Global Standards, Processes, Practices, Trainings, and implementation tools and ensure they are designed according to regulatory, industry and company expectations.
• Provide governance, lead the implementations of improvement initiatives and foster a robust compliance mindset.
• Ensure processes are executed consistently across the organization and monitor signals to drive continuous improvement.
• Act as the leader and SME to ensure supporting IT applications and analytical tools are configured and maintained to support the business needs and facilitates accurate reporting and analytics.
• Define a common set of global effectiveness and efficiency metrics to drive end-to-end performance.
• Monitor performance metrics, report and provide insights to inform decision making to drive further improvements.
• Develop, lead, mentor and maintain a community of cross-functional SMEs to collaborate on proposed improvements and deepen the knowledge of the associated processes & tools.
• Actively collaborate with enterprise-wide teams on standardized global business processes.
• As the subject matter expert, ensure inspection readiness, directly interact with Health Authorities during inspections and draft responses to observat