Job Description

Business Unit- CMR- Regulatory Affairs & Quality

Does your motivation come from challenges and working in a dynamic environment? Is your ambition to create visible results? Are you enthusiastic about understanding the business and bringing attention to key business challenges? Then we might have the right position for you. Apply now with your latest profile and you may be our new Associate Clinical Quality and Training Manager for our Regulatory Affairs & Quality Business Unit based at Bengaluru.

The Position

In line with corporate/regional/CDC priorities, plan and conduct clinical quality assurance and clinical training activities to ensure that Novo Nordisk Clinical QMS (Quality management System) is functioning in compliance with ICH/GCP (International Conference on harmonization -Good Clinical Practice) local regulatory requirements and NN Standard Operating Procedures (SOP) in Clinical Development Centres (CDC) affiliates.

You will be responsible for - * Clinical Quality: Act as the local clinical trial regulation expert and SOP in CDC affiliates. Represent the CDC in regional and global clinical quality/compliance fora as needed. Perform clinical quality support visits (CQSV) to clinical trials (project management and sites) in alignment with the regional/CDC/affiliate priorities, communicate the observations within the team, trend the observations and analyse the training gap of the CDC teams. Perform clinical quality support visits (CQSV) to clinical trials (project management and sites) in alignment with the regional/CDC/affiliate priorities, communicate the observations within the team, trend the observations and analyse the training gap of the CDC teams. Keep track of trial sites with previous quality concern, repeated issues and Plan and conduct activities within the CDC to support Audit and Inspection Readiness at all times such as:

• Risk based quality checking of Critical process and documents like Informed consent MVRs, Temperature Deviations, Hand-over process, TMF compliance

• Audit and Inspections: Ensure Inspection readiness package prepared for the high-risk sites in the CDC. Ensure all inspection and audit CAPAs (corrective actions/preventive actions) were implemented on time and documented for future references. Act as ICG Chair for all local inspections within the CDC.

• Clinical process QMR (Quality Management Review): Coordinate Clinical QMR within the CDC. Tracking of previous year's regional QMR actions and focus area and collecting and trending of compliance issues proactively. Provide CDC input to the regional clinical process QMR.

• Clinical Training: Identify training needs within the CDC and develop trainings in line with regional/CDC/affiliate needs. Ensure new hires are trained as required and on time. Plan and conduct GCP and related trainings for external stakeholders. Coordinate and/or conduct system and process trainings within the CDC, as needed. Support timely and correct implementation of changes and process improvement projects in the CDC.

• Subject Matter Experts (SME): CDC CQTMs may have additional SME roles. CQTMs having SME roles are taking part in global and regional development and improvement projects, identify re-current compliance issues and provide regional solutions and/or trainings on that specific subjects together with the regional CQTM such as: Trial product handling GTCG - Global Training Coordination Group, Clinical Deviation ,CIFG -Clinical Issues Focus Group, TMF -Trial Master File, CT SOP Council, Audit finding responsible for all critical & major findings issued for the CDC

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.
• Previous experience of GCP audits and authority inspections is preferred.
• Proficiency in both oral and written English is a must.
• Must be able to work in virtual multi-cultural teams
• Advanced ICH GCP knowledge
• Ability to collaborate and communicate with stakeholders, both internal and external at all levels.

About the department

Novo Nordisk is a Denmark based multinational with leadership in diabetes. Novo Nordisk India affiliate office is located in Bangalore & has more than 1200 people working across the country in various functions. The position reports directly to the Clinical Quality and Training Manager.

Working at Novo Nordisk

Novo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That's why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it's a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000employees. Together, we go further. Together, we're life changing.

Contact

To submit your application, please upload your CV and motivational letter online (click on Apply and follow the instructions).

Deadline

November 12, 2022

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.