Clinical Quality and Training Manager

3 months ago

Sydney, Australia Novo Nordisk Full time

**About the department**
Novo Nordisk is a leading global healthcare company with nearly 100 years of innovation and supervision in diabetes care.
The Novo Nordisk Oceania affiliate is a high performing and growing organisation operating within a dynamic healthcare environment across Australia and New Zealand. Our primary therapy areas are diabetes and obesity, and we offer a broad range of medicines within the areas of haemophilia, growth disorders and women’s health.

**The position**
The Clinical Quality & Training Manager will plan and conduct clinical quality assurance and clinical training activities, to ensure that Novo Nordisk Clinical QMS (Quality Management System) is compliant with ICH/GCP (International Conference on Harmonization-Good Clinical Practice), and local regulatory requirements in Clinical Development Centres (CDC). This role will report to Oceania CDC Head.

Main accountabilities of the position:

- Clinical Quality - plan and conduct activities within the CDC to support Inspection Readiness such as systematic quality checks for key activities & ensuring preventive actions are implemented.
- Coordinating Clinical QMR (Quality Management Review) activities in the CDC, including tracking of QMR actions and focus areas & monitoring compliance parameters for the affiliates.
- Performing clinical quality and site visits (CQSV) to clinical trial sites in alignment with the regional/CDC/affiliate priorities. Ensuring all inspection and audit CAPAs (corrective actions/preventive actions) are implemented on time and documented for future reference.
- Clinical Training - ensuring new hires, of all levels are professionally trained. Planning and conducting GCP and related training for external stakeholders, identify training needs within the CDC and other areas for development in line with regional/CDC/affiliate needs.

**Qualifications**
- Bachelor’s degree or higher is essential, preferably in the discipline of Life Sciences, Medicine, or Pharmacy.
- Minimum of 5 years of experience within clinical operations and/or clinical quality and training area, gained in the Pharmaceutical/Healthcare industry.
- Must be able to work in virtual multi-cultural teams. Approximately 70% of interactions are with internal customers and 30% of interactions are with external customers.
- Advanced ICH-GCP knowledge with previous experience in GCP audits and authority inspections is preferred.
- The position requires a relatively moderate to high (approximately above 30%) of travelling regionally and occasionally overseas. High Proficiency in oral and written English.

**Working at Novo Nordisk**
We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities, and challenges. For employees at Novo Nordisk, life means many things - from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease.

**Contact**

**Deadline**

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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