Role Summary
Sr. Director, Global Process Owner for Supplier Quality Management. Leads the global quality system for supplier (third party) quality management, providing strategic oversight of standards, processes, practices, trainings, and tools. Collaborates across functions to ensure compliance with regulatory expectations and drives global standardization and continuous improvement.
Responsibilities
- Establish and maintain the global quality system for Supplier (Third Party) Quality Management to drive standardization globally.
- Own Global Standards, Processes, Practices, Trainings, and implementation tools; design them according to 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 for continuous improvement.
- Act as leader and SME to ensure IT applications and analytical tools are configured and maintained to support business needs and enable reporting and analytics.
- Define a common set of global effectiveness and efficiency metrics to drive end-to-end performance.
- Monitor performance metrics, report insights, and inform decisions to drive improvements.
- Develop, lead, mentor, and maintain a cross-functional SME community to collaborate on improvements and deepen knowledge of processes and tools.
- Collaborate with enterprise-wide teams on standardized global business processes.
- As the subject matter expert, ensure inspection readiness, interact with Health Authorities during inspections, and draft responses to observations as needed.
- Engage with external and industry organizations to monitor policy changes and influence quality-related policies and regulatory requirements related to supplier quality management.
Qualifications
- Required: 10+ years’ experience in the pharmaceutical or other regulated industry with demonstrated knowledge and application of applicable regulations and quality systems, including leadership or direct influence.
- Required: Bachelor’s degree in sciences, engineering, or other healthcare-related field.
- Preferred: Direct experience in external party or supplier/vendor quality management in a regulated industry.
- Preferred: Proven ability to work in a matrixed organization, leading diverse teams and influencing areas not under direct control.
- Preferred: Experience leading a major multi-site or global functions improvement initiative.
- Preferred: Strong strategic thinking with ability to execute strategic decisions while balancing priorities.
- Preferred: Proficiency in addressing operational challenges through structured approaches and innovative solutions.
- Preferred: Ability to drive process improvements and strategic decisions by analyzing and interpreting complex data.
- Preferred: Demonstrated change agility and ability to lead others through change and ambiguity.
- Preferred: Excellent teamwork, interpersonal, and communication skills across all levels and formats.
- Preferred: Expertise in developing scalable and standardized processes across global operations.
- Preferred: Demonstrated influential leadership with senior-level functional leads.
- Preferred: Strong leadership to balance speed, quality, and risk in delivering results.
- Preferred: Governance skills with proactive risk management in quality and regulatory areas.
- Preferred: People management experience.
- Preferred: Experience navigating global regulatory standards and frameworks.
- Preferred: Experience leading multisite improvement initiatives or standardization efforts.
- Preferred: Experience with eQMS systems.
Skills
- Leadership and people management
- Strategic thinking and execution
- Regulatory and quality systems expertise
- Governance and risk management
- Change management and adaptability
- Data analysis and metrics-driven decision making
- Cross-functional collaboration and stakeholder management
- Communication at all organizational levels
- Process standardization and global implementation
- IT systems alignment with business needs
Education
- Bachelor’s degree in sciences, engineering, or other healthcare-related field
Additional Requirements
- Available to travel (domestic and international) when required (approximately 10%)
- Fluent in English; additional languages recommended
- Primary location is Lilly Corporate Center, Indianapolis, Indiana, with possible consideration for other Lilly manufacturing sites