Sr. Director, Global Process Owner - Change Control

Location: Durham
Posted on: June 23, 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. About the job 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. Responsibilities : The Global Process Owner for Change Control, as a leader within the Global Quality Systems team, will establish and maintain the global quality system for change control, including Global Quality standards, practices, business processes, implementation tools and associated IT systems. Additionally, the Global Process Owner will be expected to lead the Change Control Community of Practice, including Global Process Leads and Area Process Owners. They will manage key global projects and priorities within the Quality System, including driving enhancements to the change control quality system from a current state to a desired future state. The Global Process Owner will consult with Lilly manufacturing facilities, external supplier organization, marketing affiliate quality operations, regulatory and other functions to educate on the quality system and proactively ensure compliance of Lilly’s Quality Systems with various country agency standards, industry trends and scientific principles. Key Objectives/Deliverables The Global Process Owner for Change Control is responsible for: Establishing and maintaining the global quality system for Change Control to drive standardization globally. Ensuring Standards, Processes, Practices, training, and implementation tools are designed according to regulatory, industry and company expectations. Driving governance of improvement initiatives and fostering a robust compliance mindset. Ensuring processes are executed consistently across the organization and monitoring signals to drive continuous improvement. Defining a common set of global effectiveness and efficiency metrics to drive end-to-end performance. Monitoring performance metrics, reporting and providing insights to inform decision making to drive further improvements. Leading a community of cross-functional SME’s to collaborate on proposed changes and deepen the knowledge of the associated processes & tools. As the subject matter expert, 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 Change. Ensure supporting IT applications and tools are configured and maintained to support the business needs and facilitates accurate reporting and analytics. Basic Requirements: 12 years pharmaceutical industry experience across Research and Development or commercial manufacturing in a manufacturing, validation, and/or Quality roles supporting product manufacturing Bachelor’s degree in Natural Science, Engineering, Pharmacy, or other Life Science-related field. Experience with cGMP and quality systems, including EU and US guidance and regulations. Additional Skills/Preferences: Expertise in developing scalable and standardized processes across global operations to improve efficiency and reduce complexity. Demonstrated influential leadership expertise and experience with senior-level interactions within GxP functional areas and Global Quality. 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. Prior work Overseeing change control programs. Proven ability to work in a matrixed organization with diverse teams and influencing areas not under direct control. 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. Additional Information: Must be available to travel (domestic and international) when required (approximately 10%) Must be fluent in English, additional languages are also recommended Role can be based at Indianapolis or some other US manufacturing locations. 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: , Greenville , Sr. Director, Global Process Owner - Change Control, Science, Research & Development , Durham, North Carolina