DirecciónLead Auditor GCP
Category: Quality
Location: Ciudad de México, Ciudad de México, MX
Position for GBS Mexico
Join Novo Nordisk for a life-changing career establishing and developing a world-class Global Business Service Centre (GBS) in Mexico City. This will impact millions of people living with a chronic disease like diabetes and obesity. It will also impact your professional and personal development through offering you the unique chance to pioneer and build an agile unit offering vital business support to the Americas. Get to know us better by visiting our website.
Are you passionate about ensuring the highest quality in clinical trials and seeking a global role as part of a remarkable team committed to advancing the way clinical trials are conducted? Can you bring a ‘can-do’ attitude to support high quality in the development of innovative treatments for patients? If so, you might be the new GCP Lead Auditor we are looking for to join our Novo Nordisk family in Mexico City, Mexico. Apply now and be part of a life-changing career!
The Position
As our new Good Clinical Practice (GCP) Lead Auditor, you will join GLP & GCP Audits in the Quality Audits department and be responsible for overseeing, assisting, and reporting on GCP audits in compliance with Novo Nordisk's quality systems, GCP guidelines, and relevant international and national regulations. The ideal candidate will have experience in this area and possess the ability to both work independently and as a part of a global team.
Your primarily tasks will include:
- Planning, preparing, and conducting assigned audits in accordance with the annual audit program.
- Ensuring appropriate escalations to responsible management in case of critical audit findings and support immediate follow-up measures according to Novo Nordisk requirements
- Participating in audit process development and maintenance
- Monitoring new compliance trends, signals and contribute to projects for process improvements
- Presenting the potential trends and signals to relevant stakeholders
- Please consider the exciting opportunity for international travel as part of your role on our global team.
Qualifications
- Bachelor’s degree within science, pharmacy, biologist or similar. Master’s degree, relevant PhD or equivalent within science, pharmacy, biologist or similar (desirable).
- Minimum 8 years of relevant experience within pharmaceutical, biotechnology, or CRO and/or healthcare setting.
- Thorough understanding of relevant regulatory requirements within GCP as well as strong knowledge of working with Quality and Quality Management systems
- Excellent verbal and written English knowledge along with outstanding stakeholder and change management skills.
- Previous experience working as an auditor is preferred but not a must
- Enjoy working independently and lead yourself and others.
About the Department
The Quality Audits department in Novo Nordisk Quality is responsible for the implementation and delivery of a global cross-functional audit program across Novo Nordisk. We are helping to ensure that Novo Nordisk maintains the highest standards of compliance and quality in our processes and operations. In the GLP & GCP area here, you will report to the Director in Denmark and collaborate closely with other auditors in Denmark, North America, and India.
Working at Novo Nordisk
Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 63,000 employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we're working toward something bigger than ourselves, and it's a collective effort. Join us! Together, we go further. Together, we're life changing.
Contact
To complete your application, please submit your CV by clicking "Apply now" and following the instructions. For more details, follow our LinkedIn page: Novo Nordisk: About | LinkedIn
Deadline
Apply before February 23rd, 2024.
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.
