Senior IT Validation & Compliance Specialist I

Department – Validation Center of Excellence (CoE)

Are you passionate about leading a team of Validation and Compliance Specialists? Do you have a knack for driving continuous improvements and innovation? If so, we invite you to apply for the Senior IT Validation and compliance specialist I position at Novo Nordisk. Read more and apply today for a life-changing career.

The position 
As a Senior IT Validation and Compliance Specialist I at Novo Nordisk, you will have the following responsibilities:

• Define and execute validation and qualification strategies for GxP Computerized Systems, Computerized Equipment, Infrastructure, or Robotic Process Automation (RPA) and Emerging Tech such as Artificial Intelligence (AI) and Machine Learning (ML).
• Develop validation plans, validation reports, design reviews, test strategies, and execute validation activities.
• Ensure systems are in compliance with relevant internal and external regulatory requirements.
• Participate in audits and inspections, identifying and implementing solutions to compliance gaps.
• Provide compliance consulting for IT projects and deliver compliance deliverables related to Computer System Validation (CSV). Manage multiple concurrent tasks and be flexible in handling complex projects. Mentor and guide junior colleagues in validation activities.

Qualifications
To be successful in this role, you should have the following qualifications:

• You hold Bachelors or Masters in relevant field with minimum 10+ years of experience in working in a service -based organization/pharmaceutical industry preferably in the IT quality domain and preferred to have Industry recognized ITIL and ISO quality management certification.
• You should have minimum 7+ years of practical experience in GxP areas with exposure to regulatory affairs, 7+ years in performing Root Cause Analysis (RCAs), 2+ years in service management and any other relevant IT quality activities.
• Proven management skills in quality as well as validation activities and Global Stakeholder Management in Pharmaceutical field and expertise in SDLC and STLC.
• Knowledge of and experience with regulatory requirements (e.g. GMP, 21 CFR Part 11), GxP, self-driven to ensure that the IT systems will pass inspections from the authorities without problems.
• You should have experience in Risk assessment and exposure to Test management tools such as HP ALM.
• Should be able to effectively manage employee utilization and maximum efficiency with right balance on employee engagement, coach and develop employees.
• Expert in performing validation activities for complex projects and ability to represent NN in relations with users and external stakeholders.
• Strong interpersonal, analytical, communication and collaboration skills and ability to represent NN in relation with users and external stakeholders.

About the department.
Validation CoE is the unit responsible for validation and qualification of various systems, applications and infrastructure in different business areas. These systems are used on a local, regional, and global scale by many areas of the business, including Sales and Marketing, Production sites etc. and are critical to the execution of key business process such as development, manufacturing, sales, finance, etc. This unit is responsible for validation these systems/ Qualification of underlying infrastructure and maintaining the systems in the validated state throughout in its operation.

Working at Novo Nordisk
Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 63,000 employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we’re working toward something bigger than ourselves, and it’s a collective effort. Join us! Together, we go further. Together, we’re life changing. 

Contact
To submit your application, please upload your CV online (click on Apply and follow the instructions).
Apply Now!

Deadline
10 April 2025.

Disclaimer
It has been brought to our attention that there have recently been instances of fraudulent job offers, purporting to be from Novo Nordisk and/or its affiliate companies. The individuals or organizations sending these false employment offers may pose as a Novo Nordisk recruiter or representative and request personal information, purchasing of equipment or funds to further the recruitment process or offer paid trainings. Be advised that Novo Nordisk does not extend unsolicited employment offers. Furthermore, Novo Nordisk does not charge prospective employees with fees or make requests for funding as a part of the recruitment process.

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.