Sr. Principal Scientist, Quality Control – Laboratory Informatics Join Lilly to apply for the Sr. Principal Scientist, Quality Control – Laboratory Informatics role at BioSpace.
Position Overview Lilly is actively expanding its manufacturing footprint worldwide and seeks experienced quality assurance associates to support growth in Kenosha County, Wisconsin. This Senior Principal Scientist will serve as a business representative for laboratory IT systems, mentor peers on system use, support regulatory audits, manage laboratory quality documentation, and lead the deployment and upgrade of QC laboratory IT systems such as Empower, NuGenesis, MODA, and Labvantage.
Responsibilities Maintain a safe work environment, lead safety initiatives, and support corporate and site health, safety, and environmental goals.
Perform or support validation of laboratory equipment and software systems.
Support the establishment and maintenance of validated software‑based computerized systems in the lab.
Ensure data integrity by design within the QC laboratory.
Lead site deployment and upgrade of QC laboratory IT systems such as Empower, NuGenesis, MODA, and Labvantage.
Partner and build relationships with Global Quality Laboratory Network and Global IT team members.
Act as business owner and subject‑matter expert for QC laboratory IT systems.
Collect data and author management review documents for the laboratory quality system.
Provide oversight and support continuous improvement of quality systems as they relate to the QC lab.
Apply knowledge of quality principles, cGMP, and laboratory systems to develop and execute local procedures, training courses, and practices.
Assist in improvement of quality systems by creating or revising worksheets, developing or updating laboratory execution system documentation, updating laboratory methods, and maintaining other lab documentation systems.
Manage and support audit and inspection activities for the laboratory.
Manage methods in the QC Laboratory.
Perform and mentor others in change control, analytical investigations, root cause investigations, and activity planning.
Implement and comply with corporate, site, and laboratory safety standards.
Develop training materials.
Basic Requirements Bachelor’s degree in a science, engineering, or pharmaceutical‑related field or equivalent experience.
Minimum 6 years in the pharmaceutical industry with specific Quality Control and laboratory computer system experience.
On‑site presence required.
Additional Skills/Preferences Fluent in English.
Demonstrated understanding of cGMP regulations.
Previous experience in GMP production environments.
Proficiency with applicable computer systems.
Deep understanding of compliance requirements and regulatory expectations.
Demonstrated understanding of analytical skills.
Proficiency with computer systems including Microsoft Office products, LIMS, Laboratory Execution Systems, chromatography systems, electronic laboratory notebook systems including implementation of systems.
Ability to work in a lab environment including wearing appropriate PPE and other safety related equipment or considerations.
Excellent written and oral communication skills.
Previous LEAN experience: ability to drive continuous improvement.
Experience operating or implementing Lab IT systems including LIMS and Automated Lab Execution systems.
Strong technical aptitude and ability to train and mentor others.
Project management experience.
Demonstrated problem‑solving and decision‑making capability.
Demonstrated technical writing skills.
Understanding of statistical tools and analyses.
Strong documentation skills and attention to detail.
Demonstrated strong oral and written communication skills.
Demonstrated interpersonal skills and the ability to work as a team.
Root cause analysis/troubleshooting skills.
Demonstrated attention to detail and ability to maintain quality systems.
Proven ability to work independently or as part of a team to resolve an issue.
Previous regulatory inspection readiness and inspection execution experience.
Additional Information Primary location is Kenosha County, Wisconsin.
Ability to travel (approximately 10%).
Ability to work overtime as required.
Equal Employment Opportunity 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.
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.