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 / Advisor / Sr. Advisor – Quality Data Digital Transformation will act as a change agent within the Lilly Product Research and Development (PR&D) organization to transform PR&D data collection, record execution, data analysis, and data visualization to provide safe, effective, and quality clinical trial medicines and quality information supporting the clinical trial portfolio.

The Sr. Principal Associate / Advisor / Sr. Advisor - Quality Data Management position is a part of the PR&D Quality Assurance Data Management team, reporting to the PR&D Site Data Leader. This role will oversee Quality oversight for data and records digitization transformation across all GMP functions of PR&D (i.e., manufacturing, laboratory, packaging/labelling, warehousing & distribution).

In addition to supporting GMP deliverables, the Sr. Principal / Advisor / Sr. Advisor – Quality Data Digital Transformation will serve as QA subject matter expert for data management within PR&D Development Organization (R&D), strategically implementing data integrity and data governance processes into the design of computer systems, tools, and digital applications to accelerate the Lilly pipeline and provide transformative medication to patients.

Position Responsibilities:

• Data integrity subject matter expert
• Lead the development and implementation of advanced digital data documentation and record management strategies within PR&D
• Collaborate with cross-functional teams to identify and prioritize records for digitization
• Subject matter expert for PR&D paper execution records procedure and controlled printing processes
• Provide leadership for paper execution record QA reconcilers. Provide guidance across PR&D for users of paper execution records, increasing understanding of Good Documentation Practices and improving compliance on an ongoing basis
• Monitor and report on the health of PR&D paper execution record processes
• Provide business quality assurance (BQA) leadership and influence for the implementation of digital application/systems within PR&D, ensuring data integrity is built into the design of apps and systems use to collect, report, and visualize GMP data and records
• Lead and influence the application of data integrity by design in the development and implementation of PR&D Development Mode data management computer systems, tools, applications and processes
• Monitor and report on the progress of the digitization projects, identifying and mitigating risks as needed
• Represent PR&D on the Lilly global Digital Operation for Manufacturing Excellence community and provide influence on digitization execution strategies as medicines move across the clinical trial pipeline to commercialization
• Lead the preparation of data integrity/data management topics for audit and inspection readiness, focused on, but not limited to, the management of data and records within PR&D
• Network and provide influence across Lilly manufacturing, quality, and Tech@Lilly data management organizations in the implementation of quality systems and share best practices
• Ensure continuous professional development, education, training and knowledge of data integrity and data management processes and actively engage in mentorship and coaching to PR&D personnel
• Serve as a standing member of the PR&D Data Integrity Governance Council.

Minimum Qualification Requirements:

• Bachelor’s degree in science, engineering, or computer science or related field
• 5+ years of experience working in a GMP, GCP, or GLP environment
• Strong knowledge of quality business processes and quality requirements

Additional Preferences:

• Demonstrated understanding of quality management system principles, including policies, procedures, and processes
• Proven project management abilities (e.g. Six-Sigma principles)
• Capability to work independently and prioritize solutions for critical issues
• Critical thinking / problem solving skills
• Strong communication skills and ability to work across and influence PR&D business functions (i.e., manufacturing, packaging, labeling, analytical, & product delivery)
• Understanding of the application of computer system/applications/tools utilized (i.e., Tulip, KNEAT, Veeva, Excel, Power Bi, R, Tableau) preferred.

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 an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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