Lead Quality Audits | Novo Nordisk | Bangalore

Job Description

Department – Quality Audits GBS

The position:

As a Lead GCP (Good clinical Practise) Auditor, you will be working in the domain of GCP..  You will conduct audits to provide assurance of Patient Safety, Product Quality, and Compliance to the organization. 

You are entrusted to fulfill the following responsibilities::

• Have a 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 organizational levels.

Qualifications:

• Bachelor or Master 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 another role within clinical drug development.
• Knowledge of the pharmaceutical industry (GxP) is a must.
• Thorough understanding of relevant regulatory requirements.
• Excellent communication skills – written and verbal.
• The ability to create rapport with stakeholders by being curious 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 behavior.
• Commitment to ensuring the safety of trial subjects and data integrity for the purpose of the 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 view challenges with an analytical and pragmatic mindset.
• 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 working in a dynamic environment with changing priorities.

About the department

Novo Nordisk Quality GBS was established in May 2015. We are responsible for supporting and developing 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 ensuring 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.

Apply on or Before 12th May 2023