Job Description

Department: IT Quality

Does your passion come from working in a challenging environment while implementing quality aspects in IT systems? Are you looking for a work environment with multinational working culture, collaborating with global stakeholders and senior leadership? Do you have a passion for quality and have lean mindset? Are you passionate and excited about guiding and collaborating with experienced IT Quality Assurance associates? Are you good at maintaining balance while working / leading IT quality area and collaborating with senior leadership and stakeholders? Do you have curiosity and keenness for scientific risk-based quality approach? If so, grab an exciting opportunity waiting for you as \xe2\x80\x9cLead IT Quality Advisor\xe2\x80\x9d with us. \xe2\x80\x9cApply now\xe2\x80\x9d - At Novo Nordisk, we assure you will experience the best.

The Position

As a Lead IT Quality Advisor (IT QA), you will ensure fulfilment of Quality Assurance (QA) responsibilities and IT QA support for IT systems and projects (as defined in the ITQA system portfolio), hereunder approval of quality documents, advise on quality matters, and assistance in closing compliance gaps found in audits and inspections. You will be responsible for IT process strategy preparation and implementation. You will be responsible for handling complex GxP programs with multiple GxP systems working with senior global stakeholders. Ensure scalable QMS to be used for digitalisation (Applying risk-based approach to secure fit for purpose). You will be trusted to fulfil below responsibilities:

• Act as Line of Business QA for Global IT and ensure close alignment of quality in the IT Process.
• Ensure a simplified quality setup to support NN digitalisation and ensuring a fit for purpose and scalable QMS to be used for digitalisation.
• NN Quality ambition implementation.
• Liaison globally with internal and external stakeholders in developing and optimising quality related processes to meet business challenges and regulatory requirements.
• Drive organisational change management activities anchored in IT Quality.
• Keep deep knowledge of the Novo Nordisk QMS and external requirements to coach and advice line management and QA.
• Support and coach QAs to resolve quality and compliance related problems related to quality management of IT and digital solutions.

Qualification

• 12+ years of experience in the field of BE, M.Sc., B.Sc. or similar graduate degree in relevant field (Computer Science, IT Quality).
• 5+ years of practical experience in GLP/GMP/GCP/pharmacovigilance areas .
• 5+ years of practical experience in Steering Committees and System Advisory Board.
• 3+ years as an ISO 9000 Lead Auditor or equivalent IT quality auditing experience.
• 2+ years of practical experience with IT QA work in GxP areas.
• Strong leadership and change management competencies.
• Good understanding of Quality and security for IT systems in general.
• Strong knowledge of quality requirements for the Pharmaceutical Industry from working in GMP/GLP and GCP related areas.
• Strong knowledge of maintaining a Quality Management System and certificates.
• Working experience in providing IT quality advisory for emerging technologies like cloud infrastructure, robotics, AI/ML.

About the Department

IT QA Department in India is an extended unit of Denmark with about 20 experienced IT Quality Advisors who constantly challenges, raise the bars and supports different system/service portfolios across Global IT. We are responsible for managing ITQA tasks for corporate GxP IT systems, Robotics, Infrastructure and other latest digital solutions like AI/ML. We focus on providing high-quality services using simple and agile processes to ensure compliance. In IT QA department we have highly motivated, engaged, and independent colleagues working in an international environment where we challenge, share our knowledge and actively maintains an open culture.

Working At Novo Nordisk

We are a proud life-science company, and life is our reason to exist. We\xe2\x80\x99re inspired by life in all its forms and shapes, ups and downs, opportunities, and challenges. For employees at Novo Nordisk, life means many things \xe2\x80\x93 from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energize us to perform our best at work. Ultimately, life is why we\xe2\x80\x99re all here - to ensure that people can lead a life independent of chronic disease. Today, we are thousands of colleagues applying our passion, skills and commitment to our purpose of driving change to defeat serious chronic diseases, built upon our heritage in diabetes. We don\xe2\x80\x99t wait for the change, we drive the change.

Contact

If you believe you are a match for the above requirements and are willing to take up the role, please apply here with our online application tool.

Deadline

9th October 2023.

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\xe2\x80\x99re life changing.

Novo Nordisk