Senior Director, Global Process Owner - Document Management 5 Locations

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 Senior Director, Global Process Owner for Document Management, as a leader within the Global Quality Systems team, will establish and maintain the global quality system for Document Management. They will provide strategic oversight and expertise for the global Document Management process, including the implementation of the Quality System Structure, the Quality Manual, Global Quality System standards, practices, business processes, implementation tools and associated IT systems. Additionally, the Global Process Owner will lead the Document Management Community of Practice, including Global Process Leads and Area Process Owners. They will lead key global projects and priorities within the Quality System.  

The Global Process Owner will consult with users from Research, Development, Commercial Manufacturing 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 Senior Director, Global Process Owner for Document Management is responsible to: 

• Establish and maintain the global quality system for Document Management to drive standardization globally.  

• Own the Quality Manual, 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 Document Management.  

• Responsible for the Quality System Architecture and manage the overall periodic review schedule. 

• Own the processes and chair the global review boards for creation of, or update to, global documents.  

 
Basic Requirements: 

• 10+ years’ experience in the pharmaceutical industry in GxP roles. 

• Bachelor’s degree in Natural Science, Engineering, Pharmacy, or other Life Science-related field. 

• Experience in administration of QMS documents. 

Additional Skills/Preferences: 

• 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. 

• Prior experience owning the process or leading the team supporting the creation, revision, obsoleting and archiving of QMS related documents. 

 
Additional Information: 

• Available to travel (domestic and international) when required (ca. 10%) 

• Fluent in English, additional languages are also recommended. 

• This is an onsite role. Indianapolis is the preferred location. Other locations eligible are: Branchburg, NJ, Research Triangle Park, NC, Concord, NC or Puerto Rico.