Sr. Director -QMS Operational Controls

Role Summary

The Senior Director, QMS Operational Controls provides central oversight of Operational Controls processes, ensuring alignment with the Quality Management System (QMS) in strategy, infrastructure, and business tools. The role maintains the integrity and evolution of the process framework by developing connections, standards, and governance to support commercial and Clinical Supply functions, accountable for health, management, and reporting across the Operational Controls pillar of the QMS. The leader aligns processes with business priorities, ensures compliance, and drives quality improvements.

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‚Äôs 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.

Qualifications

• Required: 10+ years‚Äô experience in the pharmaceutical industry in business or quality operational roles across Research and Development or commercial manufacturing.
• Required: Bachelor‚Äôs degree in Natural Science, Engineering, Pharmacy, or other Life Science-related field.
• Preferred: Experience leading a major multi-site or global functions improvement initiative.
• Preferred: Proven ability to work in a matrixed organization leading diverse teams and influencing areas not under direct control.

Skills

• Strong strategic thinking with the ability to execute strategic decisions while balancing conflicting priorities.
• Ability to drive process improvements and strategic decisions by analyzing and interpreting complex data.
• Demonstrated change agility in anticipating and leading others through change and ambiguity.
• Excellent teamwork, interpersonal, and communication skills across all levels and formats.
• Expertise in developing scalable and standardized processes across global operations to improve efficiency and reduce complexity.
• Demonstrated influential leadership engaging with senior-level functional leads.
• Strong leadership to balance speed, quality, and risk to deliver value-added business results.
• Capabilities in establishing governance structures and proactively addressing quality and regulatory risks.
• Demonstrated people management experience.
• Expertise in navigating and ensuring adherence to global regulatory standards and frameworks.

Education

• Bachelor‚Äôs degree in Natural Science, Engineering, Pharmacy, or other Life Science-related field

Additional Requirements

• Available to travel (domestic and international) when required (approximately 10%).