Sr. Director - Global Process Owner - Supplier Quality Management
Responsibilities
Establish and maintain the global quality system for Supplier (Third Party) Quality Management to drive standardization globally.
Own the Global Standards, Processes, Practices, Trainings, and implementation tools and ensure they are designed according to regulatory, industry and company expectations.
Provide governance, lead the implementations of improvement initiatives and foster a robust compliance mindset.
Ensure processes are executed consistently across the organization and monitor signals to drive continuous improvement.
Act as the leader and SME to ensure supporting IT applications and analytical tools are configured and maintained to support the business needs and facilitates accurate reporting and analytics.
Define a common set of global effectiveness and efficiency metrics to drive end-to-end performance.
Monitor performance metrics, report and provide insights to inform decision making to drive further improvements.
Develop, lead, mentor and maintain a community of cross-functional SMEs to collaborate on proposed improvements and deepen the knowledge of the associated processes & tools.
Actively collaborate with enterprise-wide teams on standardized global business processes.
As the subject matter expert, ensure inspection readiness, directly interact with Health Authorities during inspections and draft responses to observations as needed.
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 related to supplier quality management.
Qualifications
10+ yearsโรรด experience in the pharmaceutical or other regulated industry with demonstrated knowledge and application of applicable regulations and quality systems including leadership role or role of direct influence.
Bachelorโรรดs degree in sciences, engineering, or other healthcare-related field.
Additional Skills
Direct experience in external party or supplier / vendor quality management in a regulated industry.
Proven ability to work in a matrixed organization leading diverse teams and influencing areas not under direct control.
Experience leading a major multi-site or global functions improvement initiative.
Strong strategic thinking capability with a focus on the ability to execute strategic decisions while balancing conflicting priorities.
Proficiency in addressing operational challenges through structured approaches and innovative solutions.
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, with the ability to communicate and collaborate at all levels through various formats.
Expertise in developing scalable and standardized processes across global operations to improve efficiency and reduce complexity.
Demonstrated influential leadership expertise and experience engaging with senior-level functional leads.
Strong leadership capability to make and act on decisions while balancing speed, quality, and risk to deliver value-added business results.
Strong 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.
Experience leading a major multisite improvement initiative or driving multisite standardization.
Experience in eQMS systems.
Additional Information
Available to travel (domestic and international) when required (ca. 10%).
Fluent in English, additional languages are also recommended.
Primary location is Lilly Corporate Center, Indianapolis, Indiana but consideration could be given for a location at existing global Lilly manufacturing site.