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.
Overview Of Role
The Senior Director, QMS Operational Controls will provide central oversight of Operational Controls processes, ensuring alignment with the greater Quality Management System (QMS) in terms of strategy, infrastructure, and business tools. This role is essential in maintaining the integrity and evolution of the process framework by developing connections, standards, and governance to support commercial and Clinical Supply functions. The incumbent is accountable for health, management, and reporting across the Operational Controls pillar of the QMS framework. This leader will support excellence by aligning processes with business priorities, ensuring compliance, and driving quality improvements.
High-Level Responsibilities
- Lead Global Process Owners (GPOs) of non-Quality-owned processes to deliver process excellence in the Operational Controls Pillar of the QMS framework.
- Implement a structured governance and monitoring model to deliver excellence beyond Quality-owned processes across the framework.
- Design and develop, in partnership with Management Review, a model for determining the health of the QMS process ecosystem.
- Consult with Lilly manufacturing, external supplier organizations, marketing affiliate quality operations, research and development, and other functions to educate on the quality system.
- Proactively ensure compliance of Lilly’s Quality Systems with various country agency standards, industry trends, and scientific principles.
- Ensure the Global Standard, Processes, Practices, Trainings, and implementation tools are implemented and maintained according to regulatory, industry, and company expectations.
- Implement and continuously improve governance that results in