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Senior IT Quality Advisor

3 months ago

Bengaluru, India Novo Nordisk AS Full time
Department:

R&D Quality GBSDoes 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 PositionAs 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.QualificationGraduate / 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 departmentR&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.