Lead Auditor, Specialist

Category:  Quality
Location: 

Bangalore, Karnataka, IN

   

Are you passionate about quality and simplification? Do you want to build quality within processes in the most efficient way? Do you have an innovative mindset to drive change in a future-ready environment and support your colleagues and stakeholders by challenging the status-quo in a friendly and open-minded way? If so, there is a unique job opportunity waiting for you as our new Lead Auditor for GCP. At Novo Nordisk, we will challenge you to do the best work of your life.

 

About the department
Novo Nordisk Quality GBS was established in May 2015. We are responsible for supporting and development of overall quality services, such as training coordination, content control, digital solutions, quality and compliance management and records management for various units within Novo Nordisk.
Here, you will be a part of an ambitious, dynamic and global team consisting of over 100+ employees who ensure high quality as well as fit-for-purpose processes for the entire value chain from research to market. We make quality easy, simple and understandable.

 

Position
Quality Audits GBS is a group of highly experienced professionals in the domains of GCP, PV and IT and comprises of two groups: Auditors and Business Support Function. 
Auditors conduct audits to provide assurance of Patient Safety, Product Quality and Compliance to the organisation by following up on minor, major and critical findings with review and approval of action plans. Business Support Function team supports auditors in various tasks related to audit risk assessment and planning, audit preparation, NovoGlow registration of findings and audit report distribution. They also support various digitalisation initiatives in the area.

 

As Lead GCP Auditor you will:

  • have great impact on the quality of the clinical trial work sponsored by Novo Nordisk
  • conduct on-site and remote audits globally (expect ~ 60 travel days annually)
  • work in a dynamic area where changes to the audit schedule require high flexibility 
  • work both independently and in smaller teams
  • interact with external and internal global stakeholders at all organisational levels

 

Qualifications
Below are the required skills.

 

  • Bachelor’s or Master’s in the science/pharmacy/clinical trials
  • Minimum 10-12 years of relevant work experience. 
  • Experience from working with GCP eg. from a role as GCP inspector, CRA or other role within clinical drug development
  • A flair for IT / digitisation
  • Knowledge of the pharmaceutical industry (GxP) is a must
  • Thorough understanding of relevant regulatory requirements 
  • Excellent communication skills – written and verbal

 

Personal competencies you possess are:

  • the ability to create rapport with stakeholders by being curios for both understanding the “why” behind a decision and being able to explain the “why” behind an audit observation
  • an understanding of the ethical standards within the pharmaceutical industry and insights into your own personal code of ethics which is guiding your behaviour
  • commitment to ensure safety of trial subjects and data integrity for the purpose of development of new treatments
  • an open-minded and pragmatic approach to that compliance can be obtained by different solutions to similar challenges
  • the ability to know when to fight for a case despite resistance among stakeholders
  • an ability to viewing challenges with an analytical and pragmatic mind-set 
  • a positive attitude towards cultural differences and an interest in gaining knowledge of different cultural practices to strengthen intercultural communication and interaction
  • enjoying working with many daily contacts with different stakeholders globally, and from working in a dynamic environment with changing priorities 

 

About Novo Nordisk
Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases, such as obesity and rare blood and endocrine disorders. Novo Nordisk employs about 45,800 people in 80 countries and markets its products in around 170 countries. We 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 changing lives.

 

Contact
In case of any query please reach out to Praveen - KPKY@novonordisk.com/Karan - ZKDX@novonordisk.com

 

Deadline
13 July, 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.