Quality Assurance Systems

Quality Assurance Systems & Data Integrity Supervisor

**Category**:Quality

**Location**:Anagni, Lazio, IT
- End of 2024, Novo Nordisk acquired the manufacturing site Catalent Anagni S.r.l. with the ambition to expand our capacity to meet the needs of millions of patients.
- 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.

**The Position**
- In this position, you will lead and oversee Data Integrity Program and support computer systems validation strategy and execution at Anagni site. You will establish and enforce data integrity policies and procedures to ensure accurate and reliable data generation, recording, and reporting.
- Furthermore, you will:
- Coordinate and conduct regular Data Integrity Audits and assessments to identify gaps in QMS and data integrity practices, and initiate corrective and preventive actions (CAPAs) as required.- Collaborate with cross-functional teams to develop and implement robust data governance strategies and controls.- Provide guidance and training to employees on QMS and data integrity principles, ensuring awareness and understanding of regulatory requirements.- Ensuring readiness and participate in regulatory inspections and customer audits.- Approve Data Integrity Assessment for the new equipment/instrument and assure/oversight the execution of Data Integrity Assessment Remediation Program.

**Qualifications**
- In addition. you have:
- 1-2 yrs of experience in people management- In-depth knowledge of regulatory requirements and guidelines (e.g., FDA, EMA, ICH) related to data integrity and computer system validation- Strong understanding of pharmaceutical quality management system- Fluent English and Italian, both written and spoken

**About the Department**
- Located in Anagni, our department is dedicated to managing and supporting the organization’s information technology resources. We focus on defining and executing validation and qualification strategies for GxP Computerised Systems, Computerised Equipment, Infrastructure, and Emerging Technologies such as AI and ML. Our team is responsible for ensuring compliance with internal and external regulatory requirements, participating in audits, and finding solutions to compliance gaps. Join a dynamic and innovative team committed to excellence and continuous improvement.

**Working at Novo Nordisk**
- At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we
- seize them. From research and development, through to manufacturing, marketing and sales - we’re all working to move the needle on patient care.

**Contact**

**Deadline**
- 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.