Principal Representative, QA-Data Integrity

Location: Bloomington
Posted on: June 23, 2025

Job Description:

About the Department At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. As a part of Novo Nordisk, Catalent, Indiana LLC. in Bloomington, Indiana, is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized facility where talented teams work with innovators to help develop, manufacture and supply products to patients around the world. What we offer you: Leading pay and annual performance bonus for all positions All employees enjoy generous paid time off including 14 paid holidays Health Insurance, Dental Insurance, Vision Insurance – effective day one Guaranteed 8% 401K contribution plus individual company match option Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave Free access to Novo Nordisk-marketed pharmaceutical products Tuition Assistance Life & Disability Insurance Employee Referral Awards At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters. Leads Data Integrity Projects and Initiatives for the Bloomington site, furthermore: Responsible to implement and maintain the Data Integrity Program. Assist with the development, execution and approval of System and Validation Lifecycle Documentation for site GxP systems, including specifications, test protocols, traceability matrices, and various assessments. Complete review and approval of Computer System Validation documents in the EDMS system. Develop and implement administrative procedures for individual systems or family of systems through the creation, revision, and approval of SOPs. Review & approve Actions, Change Controls, and Deviations in the TrackWise. Able to work collaboratively interdepartmental throughout the organization to complete projects, in an assistance capacity or owner. Participate in audit trail reviews with System Owners, ensuring completion on time. Experience with providing coaching and influence around Data Integrity matters. Ensure adequate support to implement and standardize DI Requirements throughout the site. Maintain Quality Key Performance Indicators (KPls) for Quality related products Complete Data Integrity Assessments. Own and host the Data Integrity Governance meetings. Define the DI Training Program with collaboration with the training Department. Have the level of knowledge and experience to be a Data Integrity Subject Matter Expert. Able to or experienced in speaking/presenting in audits to inspectors or clients. Relationships Reports to: Senior Manager, QA Essential Functions Data Integrity Responsible to implement and maintain the Data Integrity Program Assist with the development, execution and approval of System and Validation Lifecycle Documentation for site GxP systems, including specifications, test protocols, traceability matrices, and various assessments Complete review and approval of Computer System Validation documents in the EDMS system Develop and implement administrative procedures for individual systems or family of systems through the creation, revision, and approval of SOPs Review & approve Actions, Change Controls, and Deviations in the TrackWise Able to work collaboratively interdepartmental throughout the organization to complete projects, in an assistance capacity or owner Participate in audit trail reviews with System Owners, ensuring completion on time Experience with providing coaching and influence around Data Integrity matters Ensure adequate support to implement and standardize DI Requirements throughout the site Maintain Quality Key Performance Indicators (KPls) for Quality related products Complete Data Integrity Assessments Own and host the Data Integrity Governance meetings Define the DI Training Program with collaboration with the training Department Have the level of knowledge and experience to be a Data Integrity Subject Matter Expert Able to or experienced in speaking/presenting in audits to inspectors or clients Other duties as assigned Physical Requirements Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening. Occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds. Must comply with EHS responsibilities for the position. Working conditions will be Heating Ventilation and Air Conditioned controlled. Ability to operate within a clean room environment as needed. Walking and/or standing for up to 8 to 12 hours depending on assigned area. Successful completion of gowning certification to enter and support the aseptic manufacturing areas. Qualifications Education/Experience: STEM Bachelor’s degree, highly preferred 8 years of experience with Bachelor’s degree and 4 years GxP experience or other regulated industry We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing. Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

Keywords: , Indianapolis , Principal Representative, QA-Data Integrity, Administration, Clerical , Bloomington, Indiana