Sr. Principal Quality Lab Data Integrity and CSQA

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.

The Sr. Principal Quality Lab Data Integrity and CSQA will oversee data management and integrity activities across Eli Lilly Product Research and Development (PR&D) analytical areas, along with providing CSQA support. They will champion data management improvements and sustainability efforts. This involves acting as a local data management expert to drive enhancements in data standards, business processes, and governance for continuous data integrity efficiency and effectiveness. This individual will collaborate with functional area data specialists to foresee and address key data management and integrity challenges while developing solutions that align with corporate goals. The role requires deep knowledge of GMP data flows (both electronic and paper), the application of data management and integrity principles in operational procedures, and computer system validation methods to ensure regulatory compliance, consistency, and maintenance. The Sr. Principal Lab Data Integrity and CSQA will also advance data management standards to guarantee consistency and foster a strong data integrity culture within PR&D. 

Key Responsibilities: 

• Act as subject matter expert and QA process owner for GMP analytical instrumentation data integrity compliance across the instrument and computer system lifecycle (identification/purchase, installation/qualification through retirement), ensuring alignment to computer systems and analytical instrument current regulatory and industry expectations. 

• Ensure PR&D analytical laboratories have an integrated quality system with regards to data management and data integrity that covers business processes, procedures and standards, governance processes, etc. 

• Lead programs and initiatives related to lab data integrity and data management for GMP information across PR&D laboratories, including: 

• All forms of data (electronic data, manual data) 

• Systems (integrated, stand-alone) 

• Processes (testing, review/approval, and management of data) 

• Develop and lead the implementation of a comprehensive continuous improvement roadmap to ensure PR&D analytical laboratories keep current with regulatory expectations, industry best practices, etc. 

• Lead the preparation of data integrity and data management topics for audit and inspection readiness. 

• Ensure compliance and inspection readiness of the data integrity and data management program across the PR&D analytical labs and coach individuals on inspection interactions. 

• Ensure continuous professional development, education, training, and knowledge of data integrity and data management principles. 

• Understand the various process workflow and data lifecycles within the lab environment and develop strategies to automate laboratory data workflows. 

• Network with Lilly M&Q quality and data management organizations in the implementation of quality systems and share best practices. 

• Serve as CSQA for the analytical laboratories in PR&D. 

• Serve as a standing member of the PR&D Data Integrity Governance Council. 

Basic Requirements:

- Bachelor of Science in a science-related field or equivalent experience.
- Prior experience in Analytical, Manufacturing, Engineering, Technical Services, or Regulatory Affairs.