Senior Director, Global Process Owner - Quality Risk Management

Role Summary

Senior Director, Global Process Owner for Quality Risk Management. Leads the global Quality Risk Management (QRM) system within Global Quality Systems, providing strategic oversight of standards, practices, processes, tools, and IT systems. Responsible for establishing the QRM global framework, leading the QRM Community of Practice, and guiding key global initiatives to ensure compliance and continuous improvement across Lilly’s quality operations.

Responsibilities

• Establish and maintain the global quality system for QRM to drive standardization globally.
• Own the Global Standards, Processes, Practices, Trainings, and implementation tools to meet regulatory, industry, and company expectations.
• Provide governance, lead improvement initiatives, and foster a robust compliance mindset.
• Ensure processes are executed consistently across the organization and monitor signals to drive continuous improvement.
• Lead IT applications and analytical tools to support reporting and analytics; ensure they are configured to meet business needs.
• Define global metrics to drive end-to-end performance; monitor and report insights to inform decisions.
• Develop and mentor a cross-functional SME community to collaborate on improvements and deepen process knowledge.
• Collaborate with enterprise-wide teams on standardized global business processes.
• Ensure inspection readiness as the subject matter expert; interact with Health Authorities and draft responses as needed.
• Engage with external and industry organizations to monitor regulatory changes and influence quality policies related to QRM.
• Own the global risk log/register and mitigate key quality risks; support Quality Maturity Model initiatives to integrate QRM principles.

Qualifications

• Required: 10+ years‚Äô experience in the pharmaceutical industry in GxP roles with substantial quality experience; Bachelor‚Äôs degree in Natural Science, Engineering, Pharmacy, or other Life Science-related field.
• Preferred: Experience working in a matrixed organization with diverse teams; strong strategic thinking and execution skills; ability to analyze complex data to drive process improvements; demonstrated change agility and leadership with senior-level stakeholders; experience in navigating global regulatory standards and QRM tools; exposure to Clinical Operations/Development, Pharmacovigilance, Product R&D, or Commercial Manufacturing.

Skills

• Strategic thinking with the ability to execute while balancing priorities
• Structured problem-solving and innovative solutions for operational challenges
• Data analysis and interpretation to drive decisions
• Change management and adaptability in ambiguous environments
• Strong teamwork, interpersonal, and communication skills across levels
• Development of scalable, standardized processes across global operations
• Influential leadership with the ability to engage senior functional leads
• Governance establishment and proactive management of quality/regulatory risks
• People management experience and global regulatory expertise
• Experience with QRM tools and maintenance of risk logs/registers

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.
• Fluent in English; additional languages recommended.