Clinical Quality Partner

3 weeks ago

Bengaluru, India Novo Nordisk Full time

**Department - **R&D Quality GBS

**The Position**

As a Clinical Quality Partner, you will ensure to maintain Clinical Quality compliance across International Operations (IO) for Clinical Development. You will be a member of certain councils/forums representing IO-Clinical Development. You will be responsible to proactively analyse the quality trends and share inputs to the VP of IO Clinical Development. Furthermore, you will participate in relevant audits/inspections across IO regions. Additionally, you will be accountable for:

- Plan, coordinate, and carry out relevant clinical quality support visits (CQSVs) in collaboration with IO Regional CQTMs to ensure strict adherence to ICH-GCP, NN SOPs, and all relevant local requirements.
- Take part in regional Quality Management Reviews (QMR) to ensure that the appropriate actions and strategies are planned and escalated to address key challenges and trends.
- Establish and maintain strong strategic relationships with stakeholders from all functional areas and levels of the organization, including functional heads and business unit heads in affiliates, headquarters, and IO.
- Schedule and hold regular status meetings to ensure that quality and compliance issues are addressed.
- Drive quality projects within cross functional teams, locally and globally and assure timely attainment of milestones.

**Qualifications**
- Bachelor's/degree Master's or its equivalent.
- 8-10 years of solid experience managing/conducting clinical trials/operations, clinical quality, and training with a primary focus on GCP (Good Clinical Practice).
- Extensive knowledge of good clinical and documentation practices.
- Knowledge of GCP audits/inspections.
- Strong understanding of the pharmaceutical industry and GxP.
- Global awareness and exposure.
- Proficient in Microsoft Office.
- Solid knowledge of regulatory requirements.
- Excellent analytical abilities and a quality-oriented mindset.
- Powerful communication and presentation abilities.
- Ability to provide recommendations despite uncertainty and pressure.
- Be accountable and responsible for own scope of work with a continuous focus on quality.
- Ability to manage diverse stakeholders, promote healthy cross-functional collaboration and maintain good interpersonal relationships.
- Fluent in oral and written English.

**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**

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**

20th January 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’re life changing.

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