Senior Quality & Compliance Professional
- Quality
- Denmark - Bagsværd
Are you motivated by providing quality assurance oversight and ensuring compliance whilst working at a high performance rate, driving projects and making your mark on the business? Do you thrive on analysing data, working with a high degree of flexibility, high level of responsibility whilst influencing and interacting with many different types of people at all levels of the organisation? If you find challenges like this exciting and inspiring, you may be our new Senior Quality and Compliance Professional, securing high quality standards in our work to provide the safest products to patients.
About the department
The job is located in a newly established area within Global Safety. Global Safety is globally responsible for handling of adverse events, monitoring product safety, customer complaints and potential recalls in Novo Nordisk. The primary responsibility of the Quality and Compliance department is to ensure that Global Safety is consistent and meets both external and internal requirements, including legal compliance and customer expectations. We are 10 colleagues with different professional background ensuring support to the Qualified Person for Pharmacovigilance in Novo Nordisk. Since our unit is situated in both Bagsværd and India, and works with our affiliates across the globe, you will have the opportunity to work with our global colleagues. You can therefore expect some travel per year.
The job
You will be responsible for coordinating the activities related to the compliance tracking of individual case safety report submission worldwide, including related documentation (e.g. review and approval of Time Limit Exceeds and Correction Reports). You will also be working with your peers in the maintenance, review and compliant operation of the online tools used for data collection.
You will be expected to ensure coherence between requirements and internal operating procedures and guidelines, monitor global procedures, produce data and report and advice on performance of the global compliance tracking to Global Safety and management on a regular and ad hoc basis. Other responsibilities include data trending and analysis for reports produced in the department, including writing executive summaries and conclusions based on your analysis.
You will be expected to have a good collaboration and interaction with our stakeholders which range from staff throughout Global Safety to the Regions in Operations, to ensure that the quality system is functioning properly and we are inspection ready. Furthermore, you will be responsible for providing training, tools and techniques to enable our stakeholders to achieve quality and compliance.
Ensuring safe products and compliance is at the heart of Novo Nordisk's business. By being part of establishing this new area and serve as a role model for compliant behaviour you can make a great difference.
Qualifications
You hold a Masters degree with a scientific background e.g Chemistry, Biology, Pharmacy and Engineering. Additional formal training and experience in Quality Management and Pharmacovigilance is essential.
Experience in case handling and submission to the Health Authorities is crucial. You are open-minded and enthusiastic, with the ability to work independently and internationally and drive your job responsibilities. Due to the nature of the role, you should have good co-operation skills, a high degree of flexibility and are used to delivering according to targets.
The role also requires excellent analytical skills and a strong quality orientation including the ability to focus on details and adherence to standards while maintaining a balanced business perspective. You are fluent in both written and spoken English on a professional level, and feel comfortable working with colleagues from different cultural backgrounds.
The application should be written in English.
At Novo Nordisk we use our skills, dedication and drive to help people with diabetes and change their lives. By working with us you will have the opportunity to do the same in a global business environment.
Contact
For further information, please contact Nakisa Harmes on +45 3079 1616.
Deadline
24 January 2014.
- Quality
- Denmark - Bagsværd
Are you motivated by providing quality assurance oversight and ensuring compliance whilst working at a high performance rate, driving projects and making your mark on the business? Do you thrive on analysing data, working with a high degree of flexibility, high level of responsibility whilst influencing and interacting with many different types of people at all levels of the organisation? If you find challenges like this exciting and inspiring, you may be our new Senior Quality and Compliance Professional, securing high quality standards in our work to provide the safest products to patients.
About the department
The job is located in a newly established area within Global Safety. Global Safety is globally responsible for handling of adverse events, monitoring product safety, customer complaints and potential recalls in Novo Nordisk. The primary responsibility of the Quality and Compliance department is to ensure that Global Safety is consistent and meets both external and internal requirements, including legal compliance and customer expectations. We are 10 colleagues with different professional background ensuring support to the Qualified Person for Pharmacovigilance in Novo Nordisk. Since our unit is situated in both Bagsværd and India, and works with our affiliates across the globe, you will have the opportunity to work with our global colleagues. You can therefore expect some travel per year.
The job
You will be responsible for coordinating the activities related to the compliance tracking of individual case safety report submission worldwide, including related documentation (e.g. review and approval of Time Limit Exceeds and Correction Reports). You will also be working with your peers in the maintenance, review and compliant operation of the online tools used for data collection.
You will be expected to ensure coherence between requirements and internal operating procedures and guidelines, monitor global procedures, produce data and report and advice on performance of the global compliance tracking to Global Safety and management on a regular and ad hoc basis. Other responsibilities include data trending and analysis for reports produced in the department, including writing executive summaries and conclusions based on your analysis.
You will be expected to have a good collaboration and interaction with our stakeholders which range from staff throughout Global Safety to the Regions in Operations, to ensure that the quality system is functioning properly and we are inspection ready. Furthermore, you will be responsible for providing training, tools and techniques to enable our stakeholders to achieve quality and compliance.
Ensuring safe products and compliance is at the heart of Novo Nordisk's business. By being part of establishing this new area and serve as a role model for compliant behaviour you can make a great difference.
Qualifications
You hold a Masters degree with a scientific background e.g Chemistry, Biology, Pharmacy and Engineering. Additional formal training and experience in Quality Management and Pharmacovigilance is essential.
Experience in case handling and submission to the Health Authorities is crucial. You are open-minded and enthusiastic, with the ability to work independently and internationally and drive your job responsibilities. Due to the nature of the role, you should have good co-operation skills, a high degree of flexibility and are used to delivering according to targets.
The role also requires excellent analytical skills and a strong quality orientation including the ability to focus on details and adherence to standards while maintaining a balanced business perspective. You are fluent in both written and spoken English on a professional level, and feel comfortable working with colleagues from different cultural backgrounds.
The application should be written in English.
At Novo Nordisk we use our skills, dedication and drive to help people with diabetes and change their lives. By working with us you will have the opportunity to do the same in a global business environment.
Contact
For further information, please contact Nakisa Harmes on +45 3079 1616.
Deadline
24 January 2014.