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An established industry player is seeking a Senior Director for Global Process Ownership in Learning and Development. This pivotal role involves establishing a global quality system to standardize GxP functions across all manufacturing sites. The ideal candidate will have extensive experience in the pharmaceutical sector, demonstrating strong leadership capabilities and strategic thinking. You will lead key initiatives, ensuring compliance with regulatory standards while fostering a culture of continuous improvement. Join a dynamic team dedicated to making a significant impact on global health through innovative learning solutions.
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.
About the job
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.
Responsibilities
The Senior Director, Global Process Owner (GPO) for GxP Learning and Development, will establish and maintain the global quality system for GxP Learning and Development. They will provide strategic oversight and expertise for global GxP Learning and Development processes, including Global Quality System standards, practices, business processes, training and implementation tools in collaboration with Human Performance Reliability, Lilly Global Learning & Development, and global and site analytic teams. Additionally, the Global Process Owner will
have accountability to integrate Learning and Development standardization for all GxP processes across all manufacturing sites as part of QMS I3 transformation as well as working within the Lilly Global Learning and Development cross-functional governance structure. The GPO will lead key global projects and priorities within the QMS I3 transformation.
The Global Process Owner will consult with the Lilly Learning and Development organization across Manufacturing, R&D, Regulatory, Clinical, Commercial Quality, external suppliers, and other global functions to educate on the quality system and proactively ensure compliance of Lilly's Quality Systems with various country agency standards, industry trends, and scientific principles.
Key Objectives/Deliverables
The Senior Director, Global Process Owner for Learning and Development is responsible to:
• Establish and maintain the global quality system for Learning and Development to drive standardization globally across all GxP functions including all Manufacturing sites.
• Lead the Global Standards, Processes, Practices, Trainings, and implementation tools and ensure they are designed according to regulatory, industry, and company expectations.
• Ensure governance, lead the implementation of improvement initiatives, and foster a robust compliance mindset.
• Ensure processes are executed consistently across the organization and monitor signals to drive continuous improvement.
• Participate in Lilly Global Learning & Development cross-functional governance to ensure appropriate data gathering and reporting.
• Act as a SME in collaboration with Human Performance Reliability, Global Learning Services, and Quality and site analytic teams to ensure alignment with IT applications and analytical tools supporting business needs and facilitating accurate reporting and analytics for quality compliance, patient safety and manufacturing operations.
• 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 in collaboration with Human Performance Reliability, Lilly Global Learning & Development, and global and site analytic teams to collaborate on proposed improvements and deepen the knowledge of the associated processes and 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 observations as needed.
• Actively engage in external organizations and industry forums to monitor policy changes for regulatory/external environments and advocate/influence quality-related policies and regulatory requirements related to Learning and Development.
Basic Requirements: