Job Description

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Lead Auditor

Category: Quality

Location:

Mississauga, Ontario, CA

Lead Auditor

We are looking for a GCP Lead auditor based out in our affiliate in Canada and will be part of the global GCP Audit team. If you have a passion for Clinical Trials and are enthusiastic about quality, driving compliance and bringing attention to key challenges, then this is something of your interest. Apply early and be a part of the fantastic work environment!

About the Department:

GCP (Good Clinical Practice) Audits is a part of Novo Nordisk Quality Audits, and our mission is to provide executive management with the assurance of highest quality for patients, ensuring product quality and compliance and driving improvements and simplicity across Novo Nordisk. We have the global responsibility for audits of clinical trials throughout all development phases as well as perform GCP audits of Novo Nordisk processes and of suppliers of clinical services.

The role:

As a Lead Auditor, you will be responsible for conducting and reporting GCP audits and be able to take decisions independently. You shall be able to practice independently according with the agreement with manager.

Key Responsibilities:

Your responsibilities including but not limited to the following:

• Plan, lead, conduct, document, and report GCP audits according to the requirements specified in the respective Novo Nordisk procedures as well as applicable standards, quality agreements and guidance document
• Ensure appropriate escalations to management in case of critical audit findings and support immediate follow-up measures according to Novo Nordisk requirements
• Be alert to early compliance trends and signals and act on it to increase business value
• Provide technical guidance\'s and training on audit activities
• Demonstrate ability to use competences and knowledge to improve critical core processes in own business area.
• Acknowledged as by stakeholders as expert within GCP
• Master all aspects of stakeholder management
• Embrace and drive Quality Audits key behaviours
• Participate or drive Quality Audits projects as applicable

Qualifications:

We are looking for a candidate with at least 8 years\' experience in Clinical trial with a solid knowledge of potential risk of key process. You possess 3+ years of GCP auditing experience, and are able to conduct investigator site audits, process audits, supplier audits and CSV (Computer System Validation) audits. You hold a relevant PhD, Master\'s, Bachelor\'s degree or equivalent within science, pharmacy, biology, etc.

As a person, you have strong analytical skills combined with a pro-active attitude and are excellent in communicating effectively with colleagues, as well as top management. You Show commitment to your daily work, and you are willing travel up to 30% of your time.

Working at Novo Nordisk:

We value our employees for the unique skills, backgrounds, and perspectives they bring to the table. We work continuously to help bring out the best in all our people, offering opportunities for development and creating an environment of mobility within the company. We strive to offer a workplace that\'s great to be in and to be from.

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.

Novo Nordisk