Data Integrity, Sr. Principal Associate – Lilly Medicine Foundry

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.

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 are looking for people who are determined to make life better for people around the world.

Lilly is currently constructing an advanced research facility, The Lilly Medicine Foundry, for production of active pharmaceutical ingredient (API) molecules for clinical trials located in Lebanon, IN.  This facility is Lilly’s largest investment in a clinical trial manufacturing capacity and is intended to provide APIs for current and future products, including new modalities.  This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations.  Note: Final location for this role is Lebanon, IN but flexibility to work from Indianapolis will be required throughout 2025 and 2026. 

Position Summary:

The Data Integrity Sr. Principal Associate oversees data management activities at the Foundry. The Foundry will have an advanced digital strategy that will call for data management and integrity to be designed into the operational and quality processes for the site which is crucial for product development. This role partners with functional areas to resolve key issues, align solutions with corporate and Product Research & Development (PRD) objectives, and ensure that appropriate governance is installed and operational. They will partner with the Site Data Leader for PR&D to advance data management standards and foster a strong data integrity culture at the site.

Responsibilities & Scope:

• Serve as the area process owner representing the Foundry on PR&D and corporate data integrity and data management processes and initiatives.
• Ensure alignment of local procedures to global and PR&D quality system requirements.
• Partner with business areas to identify and resolve gaps and vulnerabilities identified, applying quality risk management principles.
• Support operational and inspection readiness actions related to data management and integrity.
• Benchmark with external sources to understand industry trends and share with internal quality organizations.
• Network with Lilly quality organizations in the implementation of quality systems and share best practices.
• Provide quality guidance and recommendations with respect to Data Integrity matters.

• Support the cross-functional teams, facilitate decision making, drive progress, establish key performance indicators for work area and monitor effectiveness.
• Facilitate decision making within the team under tight deadlines.
• Effectively communicating and managing internal and external stakeholders.
• Proactively managing issues, proposing, and implementing plans to resolve as needed.
• Promote a positive quality culture and oversee quality presence in the respective business areas (e.g. manufacturing, laboratories).
• Identify and lead process improvement projects impacting multiple business areas.

Basic Qualifications:

• BA/BS degree in the Engineering, Sciences, or related field with a minimum of 5 years technical and/or quality experience in the Biopharmaceutical industry, preferred.
• Relevant industry experience in highly paced working environments. Relevant experience of working on large-scale capital project deliveries is highly desirable.
• Strong knowledge of the current GMP expectations and application of quality management systems in execution.

Additional Preferences:

           Demonstration of the following:

• Understanding of data integrity, computer systems validation per CGMPs, and an understanding of System/Software Development Life Cycle concepts.
• Ability to manage in a dynamic environment.