Department: R&D Quality GBS Job Level: 6 Does your motivation come from challenges and working in a dynamic environment Do you have an eye for detail and thrive to work in an 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 Then we might have the right position for you. Apply now and join a growing team, working in an international environment. The Position As an Advanced Quality Advisor, you will be responsible to handle and approve deviations/change requests for quality/safety/regulatory processes. Furthermore, you will participate and contribute in audits/inspections as 'Quality Advisor'. As a process QA delegate, you will carry out QA activities for the processes as per SOPs, review changes to the Quality management System (QMS), handle and approve QC documents and drive QMS improvement initiatives. We also expect this role to drive end to end thinking to make quality easy and contribute to finding the right solutions with both simplicity and compliance in mind. You are entrusted to fulfil the following responsibilities: Quality Assurance/advisor and editor (as applicable) in the Content Control Process for Line of Business. Support QMS changes through coordination and collaboration with relevant stakeholders to ensure the changes are executed/implemented in compliance and fulfil the regulatory requirements. Keep deep knowledge of the Novo Nordisk QMS and relevant external requirements to coach and advice process owners or other stakeholders and set direction for SMEs. Associate suggestions for changes/improvements with business cases quantifying benefits and enabling effective communication. Stay updated on developments within cGxP and QA in general via participation in internal and external network. Qualifications Graduate / post-graduate or Comparable degree in science or equivalent professional experience. Over-all 9-11 years of work experience within pharma or healthcare industry Experience within/from pharmaceutical quality management system e.g. GxP requirements and ISO13485 High level of experience in good documentation practices. Cross-organisational working experience Basic cLEAN experience and relevant cLEAN tools Participating in audits and inspections and compliance gaps analysis. Project Management experience is an added advantage. Excellent knowledge in core pharma GXP requirements (GLP, GMP and GCP) as well as internal requirements to keep systems/process in compliance. Impactful presentation and communication skills. Fluent English, written and spoken. 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. Deadline Apply on or before: 4th March 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.
