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.
About the 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 on your CV:
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 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 manage

Skills: Regulatory, Gxp, Gcp, Clinical Trials, Product Quality

Experience: 12.00-15.00 Years