Senior Director, Quality Systems Lifecycle Management (R&D)

Role Summary

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.

Responsibilities

• Governance & Strategy: Align to QMS structured governance and monitoring models to deliver excellence across R&D processes in Lifecycle Management and the QMS.
• Governance & Strategy: Design and develop models for determining the health of the QMS process ecosystem, with a focus on Enterprise & R&D-driven metrics and outcomes.
• Governance & Strategy: 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.
• Continuous Improvement: 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.
• Leadership, Collaboration & Stakeholder Engagement: Actively collaborate with enterprise-wide teams on standardized global business processes related to R&D and product lifecycle.
• Leadership, Collaboration & Stakeholder Engagement: 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.
• Leadership, Collaboration & Stakeholder Engagement: Build and maintain an inventory of R&D stakeholders, including functional leads.
• Leadership, Collaboration & Stakeholder Engagement: Identify and engage primary, secondary, and informed stakeholders for each process, ensuring robust communication, strategic document management, training, and delivery planning.
• Leadership, Collaboration & Stakeholder Engagement: Collaborate with R&D teams to ensure processes are fit-for-purpose and support innovation, scientific rigor, compliance, and increased value of Quality.

Qualifications

• Required: Bachelor’s degree; 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.
• Preferred: Degree in Business or Life Science-related field.
• Required: Experience leading in a matrixed organization, influencing areas beyond direct control, especially in R&D environments.

Skills

• 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.
• Analytical capability to interpret complex R&D data to inform process improvements and strategic actions.
• Change agility in anticipating and leading others through change and ambiguity in scientific and regulatory contexts.
• Excellent collaboration and communication skills across all organizational levels and formats.
• Expertise in developing scalable and standardized processes across global R&D operations to improve efficiency and reduce complexity.
• Influential leadership with experience engaging senior-level R&D functional leads.
• Decision-making leadership balancing speed, quality, and risk to deliver value-added business results in R&D.
• Governance capability and proactive handling of quality and regulatory risks in research and development.
• People management experience.
• Navigate and ensure adherence to global regulatory standards and frameworks relevant to R&D.

Education

• Bachelor’s degree (Business or Life Science-related field preferred).

Additional Requirements

• Available to travel (domestic and international) when required (0-10%).
• Location: onsite at Indianapolis, IN with the ability to work from home 4 days per month; alternate Lilly locations considered based on availability.
• Authorized to work in the United States on a full-time basis; visa sponsorship not provided.
• Reasonable accommodation requests during the application process available.