Lead Data Steward - Quality Assurance

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. #WeAreLilly

Organization Overview:

Lilly is currently constructing a cutting-edge facility for the manufacture of new modalities including Gene Therapy. At Lebanon, Indiana, this facility will be Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to design, commission, start up, and maintain the facility for both clinical and commercial supply.  This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up.

The QA Data Steward oversees critical data maintained within various automated systems, such as SAP, TrackWise, Veeva Quality Docs, Darwin, and LabVantage. The QA Data Steward performs impact analyses, ensures all data changes are properly documented and controlled, implements/verifies system changes, and performs system audits, where applicable, to ensure data integrity. The QA Data Steward may also be responsible for the creation/verification of Certificates of Analysis for semi-finished and finished commercial batches.

Responsibilities:

• Network with Global quality groups to ensure effective LP2 Site deployment and management of system data
• Provide oversight and implement/verify changes of Q-Info Records and Inspection Plans in SAP
• Perform change impact analysis, ensure compliant processing of records, system data changes, and performance of system audits
• Navigate Veeva/QualityDocs to manage new document routing, metadata for team
• Process revisions/creations of specification documents, per approved Change Controls and RCM Matrix revisions
• Process revisions/creations of LIMS product, specification, test allocation, and sampling plan master data records
• Create/Verify Certificates of Analysis for semi-finished and finished commercial batches as applicable
• Support projects/initiatives that may impact data stewardship processes and procedures

Minimum Requirements:

• High School Graduate or equivalent
• Knowledge of cGMP practices including good documentation practices, data integrity and regulatory compliance
• Experience working in SAP, Quality Management Systems, and laboratory information management systems
• Strict attention to detail and ability to effectively organize/prioritize work and meet critical deadlines.
• Ability to collaborate cross-functionally with strong written and verbal communication, problem-solving, and crisis management skills.

• Effective training skills and ability to coach others.

Additional Preferences:

• General understanding of laboratory and/or operations techniques and terminology.
• Previous experience in operations and/or quality control.
• Previous experience in Veeva/QualityDocs
• Proficient in Microsoft Word/Excel/Power Point.

Additional Information:

• Ability to work 8-12 hour shifts onsite
• During the project phase, this position will allow for a flexible working environment with the ability to periodically work remotely based on the scope and nature of the activities
• Position may require travel (10-25%) or potentially a short duration assignment at another Lilly site to establish specific computer system validation and/or data integrity knowledge

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.

#WeAreLilly