Senior Director, Quality Systems Lifecycle Management; R&D

Position: Senior Director, Quality Systems Lifecycle Management (R&D)
Location: Indianapolis

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.

Role Overview

The Senior Director, Quality Systems Lifecycle Management (R&D) oversees all processes within the Lifecycle Management pillar of the Quality Management System (QMS), focusing on research and development stakeholders. This role ensures the integrity and evolution of the process framework by establishing connections, standards, and governance to support R&D, Clinical, and Commercial Supply functions throughout the product lifecycle. The incumbent is responsible for managing, monitoring, and reporting on Lifecycle Management processes, driving excellence by aligning with R&D priorities, ensuring compliance, and advancing quality initiatives.

High-Level

Responsibilities Support teams and leaders of Global Process Owners (GPOs) for all R&D-relevant processes within the Lifecycle Management pillar, including:

Drug & Device Development, Non-Clinical/Discovery Programs, Clinical Management (including trial design, site engagement, data analysis, and disclosure of research results), Global Patient Safety, and Regulatory affairs according to the QMS global process framework.

Governance & Strategy

Align to QMS structured governance and monitoring models to deliver excellence across R&D processes in Lifecycle Management and the QMS.

Design and develop models for determining the health of the QMS process ecosystem, with a focus on Enterprise & R&D-driven metrics and outcomes.

Proactively ensure compliance with global regulatory standards, scientific principles, and evolving industry trends in R&D.

Continuous Improvement

Drive process improvements and strategic decisions by analyzing and interpreting complex R&D data.

Monitor performance metrics, report, and provide insights to inform decision-making and drive further improvements in R&D processes.

Leadership, Collaboration & Stakeholder Engagement

Develop, lead, mentor, and maintain the GPO community to collaborate on proposed improvements and deepen the knowledge of R&D processes and tools.

Actively collaborate with enterprise-wide teams on standardized global business processes related to R&D and product lifecycle.

Engage in external organizations and industry groups to monitor policy changes for regulatory/external environments and advocate/influence quality-related policies and regulatory requirements in R&D.

Build and maintain an inventory of R&D stakeholders, including functional leads.

Identify and engage primary, secondary, and informed stakeholders for each process, ensuring robust communication, strategic document management, training, and delivery planning.

Collaborate with R&D teams to ensure processes are fit-for-purpose and support innovation, scientific rigor, compliance, and increased value of Quality.

Basic Requirements

Bachelor’s degree - Preferred Degree in Business or Life Science-related field.

10+ years’ experience in the pharmaceutical industry in business or quality operational roles, with significant understanding of research and development processes and/or clinical operations.

Additional Skills/Preferences

Proven ability to lead in a matrixed organization, influencing areas beyond direct control, especially in R&D environments.

Experience driving multi-site or global improvement initiatives in R&D.

Strong strategic thinking with ability to execute strategic decisions while balancing conflicting priorities in research and development.

Skilled in analyzing complex R&D data to inform process improvements and strategic actions.

Demonstrated change agility in anticipating and leading others through change and ambiguity in scientific and regulatory contexts.

Excellent collaboration and communication…