It Compliance Lead

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Do you have a solid understanding of IT, compliance, and business processes? Are you enthusiastic about driving validation of IT Systems and Computerized Equipment, bringing our IT landscape to the next level and scaling it up to match our new strategy? If yes, apply now and become a part of a diverse, global team, and contribute to transforming healthcare with your expertise. Join us and make a difference!

Let’s talk about the role
As a IT Compliance Lead, you will be a part of the Data Enablers department within Product Supply data Foundation.
Your main responsibilities will include:

• Defining and executing validation and qualification strategy, preparing, and following-up on validation plans.
• End-to-end validation and qualification activities including making a Validation plan, Validation report, Design Review, Test strategy and execution etc.
• Ensuring validated state of the system by performing Periodic Reviews, addressing deviations, creation and maintenance of system documentation and instructions in cooperation with System Managers and IT responsible when needed.
• Ensuring that systems are in compliance with relevant internal and external regulatory requirements.
• Participating in audits and inspections including finding solutions to compliance gaps identified in audits and inspections.
• Fostering strong relationships with colleagues and stakeholders through effective communication, including workshops and risk assessments.

Which competencies to bring?
We are looking for an ambitious and proactive colleague who can contribute to the team both professionally and personally. To succeed in the role, you have a proven track record in most of the following:

• Academic degree within Engineering, Chemistry, Pharmacy, IT or similar.
• Have a deep understanding of relevant regulations, standards, and guidelines. You should be able to interpret and apply these requirements to your organization and provide guidance to others on how to achieve compliance.
• Extensive and proven manufacturing/production experience with recognized GMP certificate/qualification.
• Have experience in validation methodology, including developing and executing validation protocols, creating validation plans, and performing risk assessments.
• You should have excellent communication skills and be able to effectively communicate with stakeholders, team members, and management. You should be able to articulate compliance requirements and validation strategy and provide guidance on best practices.
• You are able to identify and solve problems related to compliance and validation, anticipate and mitigate risks, and provide guidance on corrective actions. Your skills and experience allow you to investigate and troubleshoot issues and develop solutions that address root causes.

On personal level, you are passionate, self-organised, team player, and strive for continuous improvement. You have ability to ensure a healthy, engaging, and inclusive work environment.

The team waiting for you
Data Enablers department is responsible for continuously developing, scaling, and maintaining global production data platforms. These data platforms are designed to efficiently extract and standardize data from both production lines and IT/OT systems used in production processes. In Data Foundation, we strive to empower our colleagues in Novo Nordisk Product Supply to make data-driven decisions, continuously digitalize, and improve manufacturing processes. The team is very diverse both in terms of capabilities and background, with roles spanning from product owners, scrum masters, architects to hands-on data engineers and developers, and people from 15 different nationalities.

We are currently located in Ballerup and part of DD&
IT – a global community of 3000+ colleagues, driving digital, data, and IT. DD&
IT partners with the business to support digital transformation and innovation in all parts of the Novo Nordisk value chain – from idea to patient. We accelerate digital value creation through standardised, efficient, and secure technology platforms – the foundation for everything digital in Novo Nordisk.
Be part of the Novo Nordisk family
Novo Nordisk is a global healthcare company headquartered in Denmark. For 100 years, we have been driving change to defeat diabetes and other serious chronic diseases. As a result, our treatments today benefit millions of people living with diabetes, obesity, and rare blood and endocrine diseases. We are proud of that.

We are proud of our people too, and we employ more than 57,000 bright and diverse minds in 80 offices worldwide. With us, your bright mind and commitment help us change lives for people worldwide. In exchange, we offer you a seat in a rewarding and purpose-driven culture where your professional and personal development is highly valued. That said, opportunities are many in Novo Nordisk.

Bring your questions
For further information, please contact Head of Data Enablers Anna Revva +45 30 77 67 80.
Deadline
23 June 2024

To ensure a fair and equal recruitment process, please refrain to add a picture in your CV.

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.

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