LabVantage Master Data Steward Lead US, Indianapolis IN

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.

Company 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 39,000 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.

Key Responsibilities:

• Master data definition: Lead the team on the definition of the master data structure in LabVantage to support batch release, stability management, cleaning, and process validations for manufacture sites.
• Third party management: Engage with LabVantage to assist the Global Data Steward team on the definition and management of master data.
• Master Data Creation: Coordinate with a third party the creation of master data in LabVantage, including Products, Specifications, Sampling Plans, Analytes, and Tests to support Batch Release, Stability Management, cleaning, and process validations for manufactured materials.
• Master data delivery: Engage with site deployment coordinators to understand master data scope required by the site and delivery milestones. Ensure on time delivery of master data.
• Data Stewardship: Ensure that creation, migration, verification and testing of master data is compliant with Data Integrity and Good Manufacturing Practicies.
• Master Data loading: Partner with IT to define master data loading processes.
• Key Process Indicators: Define key process indicators to report the progress of the master data creation.
• Compliance: Ensure that the master data is compliant with data integrity and GMP requirements.
• Global Process Standardization: Be a standardization champion and influence the sites to adopt globally standardized processes and global tools to support the site’s intended use of LabVantage.
• Inspection Support: The LabVantage Data Steward Leas is part of the team that will provide answers to questions from inspections, audits, and other formal and informal assessments that impact globally owned applications and their associated workflows.

Education

• Minimum of Bachelor’s Degree or equivalent experience in Chemistry, Biology, Chemical Engineering, Pharmacy, or a related field.
• 5+ years of laboratory experience
• Experience working in/with GMP laboratories

Skills

• Strong scientific background.
• Clear understanding of quality laboratory issues and activities.
• Experience in defining and improving business processes.
• Knowledge of cGMP and quality systems.
• Strong understanding of GMP requirements and data integrity principles.
• Proven work with computer systems and their adaptability to existing business processes.
• Extensive knowledge of analytical methods, laboratory documentation and control processes.
• Knowledge of product release processes.
• Experience in defining and improving business processes.
• Ability to manage multiple priorities simultaneously.
• Effective communication/presentation skills.
• Ability to influence peers, technical leaders, and management through technical skill set and credibility.

Additional Information

This position will require occasional travel to manufacturing sites, development laboratories, and application vendors. Individual must be willing to visit laboratory and manufacturing sites involving unique PPE and/or gowning requirements. This role is primarily on-site, with the flexibility to work from home two days a week. We believe in providing a balanced work environment that supports both collaboration and individual productivity.

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

$63,000 - $162,800

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.

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