IT Compliance Manager to Manufacturing

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Hillerød

Do you have experience with managing IT systems used for pharmaceutical or regulated production purposes? Are you familiar with IT compliance processes? Do you have a strong quality mindset, a hands-on attitude, and a wish to provide support and guidance across a broad stakeholder landscape? If yes, then you could be our new IT Compliance Manager we are looking for to join us within Manufacturing IT's Biotech & Rare Disease (MIT BRD) area in Novo Nordisk. Apply today! What is the role about In today's world, change is the one thing we can count on. But whatever the future brings, our patients remain at the heart of everything we do. That's where you come in, working with dedicated colleagues in an exciting, fast-paced environment. Your responsibility will cover the following:
  • Helping to govern our IT license to operate in relation to GxP IT systems and support Associate Managers, System Owners, and IT/OT teams across BRD
  • Taking part in IT projects and be part of defining and implementing best practices around system management
  • Supporting implement changing or new requirements related to IT compliance in BRD and acting as a liaison partner for Associate Managers, System Owners, and IT/OT teams
  • Working hands-on to ensure that our systems are following relevant IT compliance requirements and that needed documentation is authored and in place
  • Preparing for approval of validation documentation together with Novo Nordisk Quality Assurance
    • Moreover, you will also ensure all relevant periodic activities are completed timely and in good quality - such as IT risk assessments, LCM assessments, periodic IT system evaluations, user review reporting, and other needed reporting. Furthermore, you will provide escalation support when needed and coordinate between relevant parties. What we are looking for To succeed in this role, you have:
  • Experience with IT systems used for pharmaceutical or regulated production purposes as well as experience with IT Projects, ISO-documented processes
  • Strong understanding in Good Manufacturing Practice (GMP) and knowledge of Good Automated Manufacturing Practice (GAMP) 5.
  • A BSc or MSc degree in Computer Science, Business Administration, Engineering, or similar backed by 3+ years of relevant experience within governance, operation, and maintenance of IT systems
  • Candidates with non-academic backgrounds and vast experience within the relevant fields will also be considered
  • Good written and spoken proficiency in Danish and English
    • On a personal level, you are a structured team player, a good communicator, and you can drive your tasks to completion. You also have a strong analytical and quality mindset and are known for building good relations with your colleagues and stakeholders at all organizational levels. The department waiting for you You will join a team with very committed colleagues, we are organisational placed in Manufacturing IT operating in building 25K to support BRD API production where we partner with production. Biotech & Rare Disease (BRD) is part of Novo Nordisk Product Supply, a global production network at the forefront of technology and quality pharmaceutical products. In BRD, we are supplying all Novo Nordisk products for Rare Diseases and using our competencies in Biotech to support the growing efforts into completely new production platforms and therapy areas for Novo Nordisk. Manufacturing IT is anchored in Digital, Data & IT and is the Novo Nordisk Product Supply partner. Working at Novo Nordisk Novo Nordisk is a global healthcare company headquartered in Denmark. For almost 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 50,000 bright and diverse minds in 80 offices worldwide. With us, your bright mind and commitment help us change people's lives 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. Contact For further information, please contact Martin Ruban Leleur, Associate Manager on +45 30 77 59 54. Deadline 16th April 2023 Interviews will be conducted on an ongoing basis, so we encourage you to apply as soon as possible. You do not need to attach a cover letter to your application, but please include a few lines about your motivation in your resume or CV. In addition, please avoid the use of photos in your CV. This makes for a better and more fair 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.


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    Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

    Arbejdsstedet er beliggende i Hillerød.

    Jobbet er oprettet på vores service den 17.3.2023, men kan have været deaktiveret og genaktiveret igen.

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