Sr. Director -QMS Operational Controls

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 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.

• 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 prioritization, decisions at the right level, and enables QMS ease of execution for required changes.

• Ensure processes are executed consistently across the organization and monitor signals to drive continuous improvement.

• Define a common set of global effectiveness and efficiency measures to drive end-to-end QMS health, enable desired performance, and build capability expertise.

• Partner with document owners to obtain potential risks associated with document changes, including regulatory non-compliance, process interruptions, or misalignment between global entities. Develop strategies and contingency plans to mitigate these risks.

• Monitor performance metrics, report, and provide insights to inform decision-making to drive further improvements.

• Develop, lead, mentor, and maintain the GPO community 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.

• Actively engage in external organizations and industry organizations to monitor policy changes for regulatory/external environments and advocate/influence quality-related policies and regulatory requirements.

• 10+ years’ experience in the pharmaceutical industry in business or quality operational roles across Research and Development or commercial manufacturing.

• Bachelor’s degree in Natural Science, Engineering, Pharmacy, or other Life Science-related field.

• Proven ability to work in a matrixed organization leading diverse teams and influencing areas not under direct control.

• Experience leading a major multi-site or global functions improvement initiative.

• Strong strategic thinking capability with a focus on the ability to execute strategic decisions while balancing conflicting priorities.

• Ability to drive process improvements and strategic decisions by…