Principal Representative, QA-Data Integrity
- Employer
- Novo Nordisk
- Location
- Bloomington, IN
- Start date
- Jan 22, 2025
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- Discipline
- Quality, Quality Assurance
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Best Places to Work
Job Details
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:
The Position
Relationships
Reports to: April Freehling
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 in of 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.
Company
Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 54,400 people in 80 countries and markets its products in around 170 countries. For more information visit novonordisk.com.
Our US Research & Development hub, located in the Greater Boston area, brings together the best talent to drive life science innovation. Located in Lexington, Watertown and Cambridge, our teams reflect the full scope of R&D, from early research through late-stage clinical development. We are building for the future by creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. By combining the speed and agility of biotech with the quality, resources, and stability of a large pharmaceutical company, our US R&D hub will benefit from the best of both worlds to develop new medicines that meet the needs of patients.
CONNECT
- Website
- https://www.novonordisk-us.com/
- Phone
- 617-612-6200
- Location
-
75 Hayden Avenue
Lexington
MA
02421
United States
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