GCP Lead Auditor
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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 Denmark, Bagsvaerd. Apply now and be part of a life-changing career! The position As our new 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, Good Clinical Practice (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 To succeed in this role, you have: • Master’s degree, relevant PhD or equivalent within science, pharmacy, biologist or similar
• 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 On a personal level, you are flexible and ready for change, curious and positive towards new learning and practices. You can communicate clearly in respect to cultural differences and give feedback in a polite, yet assertive way. Besides, you excel at handling conflicts and identifying risk areas. You are engaged and able to drive own performance but open to collaborate and be a real team player. You thoroughly understand and proactively acts upon external requirements and trends within area of expertise as well as business challenges. Finally, you have a strong ability to keep calm under pressure and can work with people around you to spread that calmness. 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 At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. Contact For further information, please contact Mathias Madsen at [email protected]
Deadline 24 March 2024 You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.
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.
• 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 To succeed in this role, you have: • Master’s degree, relevant PhD or equivalent within science, pharmacy, biologist or similar
• 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 On a personal level, you are flexible and ready for change, curious and positive towards new learning and practices. You can communicate clearly in respect to cultural differences and give feedback in a polite, yet assertive way. Besides, you excel at handling conflicts and identifying risk areas. You are engaged and able to drive own performance but open to collaborate and be a real team player. You thoroughly understand and proactively acts upon external requirements and trends within area of expertise as well as business challenges. Finally, you have a strong ability to keep calm under pressure and can work with people around you to spread that calmness. 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 At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. Contact For further information, please contact Mathias Madsen at [email protected]
Deadline 24 March 2024 You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.
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.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Bagsværd.
Jobbet er oprettet på vores service den 13.3.2024, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Øvrige
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