Senior IT Quality Advisor

4 weeks ago

bangalore, India Novo Nordisk Full time

   

 

Department:  R&D Quality GBS

      

Does your motivation come from challenges and working in a dynamic environment? Do you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essential? Do you have a can-do attitude with continuous improvement as one of your career objectives? If you are passionate about implementing good IT practices across health software/systems, and digitalisation excites you, we have a position for you. We are looking for a skilled colleague who will be instrumental in setting direction and build quality within healthcare processes in the most efficient way and enjoy helping people ensure IT quality the most efficient way. Sounds exciting? - Apply now and join a growing team, working in an international environment.


The Position

As a Senior IT Quality Advisor, you will be responsible for IT systems in the R&D organization. Your main role will be to provide support and advice on initiatives related to IT system qualification and compliance, both in R&D and R&D Quality departments. Additionally, you will participate and contribute as an IT and Quality advisor in audits and inspections. You will lead process confirmations and play a pivotal role in relevant cross-functional Novo Nordisk initiatives and projects related to IT systems. You will also be entrusted with the following responsibilities:

  • Handle and approve deviations, change requests, and compliance issues related to IT systems. Provide input on quality evaluations, support the Quality Management team in implementing IT QA-related goals, drive organizational change, and support training activities.
  • Ensure quality compliance with internal and external requirements, improve IT qualification and maintenance practices, and advise and participate in cross-functional IT projects while simplifying process and IT-related documents.
  • Documentation preparation and presentation in audits and inspections, acting as a proactive Quality and IT Advisor, and participating in follow-up of IT-related findings and action plans.
  • Lead and perform Process Confirmations. Represent quality in relevant projects and contribute to finding simple and compliant solutions. Provide expertise in quality and IT while participating in relevant projects. Ensure excellent collaboration within R&D Quality and stakeholders in the organization.
  • Attend steering committees, Change Advisory Boards, or organizational change projects as necessary. Responsible for training and mentoring employees within the IT QA Department and providing input to QMR support in QMR deliverables.

 

Qualification

  • Graduate / post graduate or Comparable degree in Science or equivalent professional experience.
  • Overall 10-12 years of work experience within pharma or healthcare/IT industry with 3-4 years’ experience within IT Quality assurance where you worked extensively with regulated IT systems regarding validation and compliance.
  • Experience within IT infrastructure integration and or experience with creating/supporting IT integration strategy is added advantage.
  • Have experience with Agile methodologies and experience in driving quality in an agile setup.
  • Experience in IT governance and strong knowledge of regulatory requirements related to IT system development and preferably also have experience with relevant ISO standards (e.g. 62304 and 82304) and how they apply to software-based products and/or IT/software engineering.
  • Experience with quality standards within IT systems (GAMP 5) and general standards (GMP, GCP and ISO, specifically ISO9001, ISO27001 and ISO13485).
  • Experience in using Microsoft Azure DevOps is preferred with cross-organisational working experience.
  • Work independently with clear and confident decision making and have high-level presentation and communication skills. 
     

About the department

R&D Quality is part of the Development Organisation and plays a vital role in supporting the drug and device development process to ensure high quality as well as fit-for-purpose processes throughout the entire value chain. We at R&D Quality support LOBs with quality processes/systems and Quality Management Systems activities across Regulatory Affairs and Global Safety, Clinical reporting GBS and Clinical Data Sciences GBS. We provide quality and compliance support to the organization being QAs for deviations, SOPs, change controls, quality monitoring, process reviews, system validations and we are quality partners in transformational projects within Development & Research and Early Development areas. We work in a global setting with focus on delivering viable products that make a difference to patients and ultimately benefit society.

 

Working at Novo Nordisk

At Novo Nordisk, we are driving change to defeat diabetes and other serious chronic conditions. Our treatments today are benefiting millions of people living with diabetes, obesity, and rare blood and endocrine diseases. From our labs to our factory floors, we are discovering and developing innovative biological medicines and making them accessible to patients throughout the world. Since the company was founded in Denmark more than 100 years ago, we have been translating the unmet medical needs of people living with serious chronic diseases into innovative medicines and delivery. Our focus is on these diseases, which affect hundreds of millions of people and are among the most urgent global health challenges. By combining our innovation and commercial excellence, we draw upon insights from patients and partners to transform bold ideas into life-saving and preventive medicines. Our ambition is to take the lead in each of these areas, driving change with an unfailing belief that it can be done.

 

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.

Apply Now

 

Deadline

24th June 2024.

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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