Global Process Owner for Regulatory Intelligence and Advocacy

Company: Eli Lilly and Company
Location: Indianapolis
Posted on: July 16, 2025

Job Description:

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. Organization Overview: 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. In Global Quality Compliance External Engagement and Advocacy we track the pulse of changing regulations and health authority expectations and work with our business partners to ensure Lilly is staying current and compliant. Responsibilities: The Senior Director, Global Process Owner for Regulatory Intelligence and Advocacy, as a leader within the Global Quality Compliance- External Engagement and Advocacy team, will establish and maintain the global quality system for Regulatory Intelligence and Advocacy. They will provide strategic quality oversight and expertise for the global Intelligence and Advocacy process, including Global Quality System standards, practices, business processes, implementation tools and associated IT systems. Additionally, the Global Process Owner will lead a Regulatory Intelligence and Advocacy Community of Practice, including Global Process Leads and Area Process Owners. They will lead key global projects and priorities related to external monitoring and advocacy. The Global Process Owner will consult with Lilly SMEs active in trade associations, advocacy and policy, affiliate and functional external monitoring, global quality systems and other functions to educate on the external monitoring system and proactively ensure compliance of Lilly’s Quality Systems with various country agency standards, industry trends and scientific principles. Key Objectives/Deliverables: The Senior Director, Global Process Owner for Regulatory Intelligence and Advocacy is responsible to: Establish and maintain the global quality system for Regulatory Intelligence and Advocacy to drive standardization globally including standards, processes, practices, trainings and tools. Ensure Lilly Q systems remain current and aligned with external regulatory requirements and 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 work with business partners to ensure supporting IT applications and analytical tools are configured and maintained to support the business needs and facilitate 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. Actively collaborate with enterprise-wide teams on standardized global business processes. As the subject matter expert, ensure inspection readiness. As needed, directly interact with Health Authorities during inspections and draft responses to observations. 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 in alignment with Lilly priorities. Basic Requirements: 10 years’ experience in the pharmaceutical industry in roles across Quality, Regulatory Affairs, Operations or R&D) Bachelor’s degree in Natural Science, Engineering, Pharmacy, or other Life Science-related field or Information Technology/Computer Systems. Direct experience with external monitoring, impact assessment, benchmarking, or policy and advocacy work with health authorities and trade associations. Demonstrated influential leadership expertise and experience engaging with senior-level leaders in industry or health authorities. Additional Skills/Preferences: Direct experience working for a regulatory authority or knowledge of health authority publication, review and commenting processes. Proven ability to work in a matrixed organization leading diverse teams and influencing areas not under direct control. Expertise in navigating and ensuring adherence to global regulatory standards and frameworks. Strong strategic thinking capability with a focus on the ability to execute strategic decisions while balancing conflicting priorities. Excellent teamwork, interpersonal, and communication skills, with the ability to communicate and collaborate at all levels through various formats. 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. Expertise in developing scalable and standardized processes across global operations to improve efficiency and reduce complexity. 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. Additional Information: Available to travel (domestic and international) when required (ca. 15 %) Fluent in English, additional languages are also recommended. Preferred location is at any Lilly site already supporting Global Quality Compliance staff positions. Remote positions may be possible. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $151,500 - $222,200 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. WeAreLilly

Keywords: Eli Lilly and Company, Middletown , Global Process Owner for Regulatory Intelligence and Advocacy, Science, Research & Development , Indianapolis, Ohio