Process Manager - Quality Specialist Recalls
Bagsværd
Are you passionate about quality and eager to shape the future of ’s Recall process? Would you like to join a dedicated team focused on refining the recall process? Do you want to interact with stakeholders across the organization and make a significant impact?
If so, apply now!
The position
We are looking for an experienced colleague to take up the position as Quality Specialist and Process Manager of the Recall process.
In this role, you will be responsible for the Novo Nordisk Recall process and global procedures, serving as the process expert for the project replacing our current IT system for handling recalls. You will collaborate closely with the colleagues in the Recalls team to continuously improve processes, training, and collaboration with internal stakeholders and Health Authorities. Key responsibilities include:
• Overseeing corporate procedures and ensuring process performance, compliance, and improvement activities within recalls.
• Managing regulatory requirements and compliance signals.
• Acting as the process expert for the new IT system handling recalls.
• Monitoring and measuring process performance using relevant metrics and KPIs.
• Supporting the organization with respect to the Recall process during global inspections.
• Mentoring and supporting colleagues in the recall process. Qualifications
As a person you are analytical, with a calm and professional authority and have a passion for process improvement. We expect you to be a team player and have a natural interest in quality processes, authority requirements and our obligations to patients world-wide.
To be successful in this role, you need the following:
• Several years of experience working in the quality area in the pharmaceutical industry and have profound knowledge of GMP and Quality Management Systems
• An academic degree in engineering, pharmaceutical sciences, or a related natural science discipline
• Experience in working with product defect investigations or recall situations
• You must be fluent in English - both written and spoken
• Good communication and facilitation skills Preferably you have experience with:
• Audits & Inspections in the pharmaceutical industry
• Process landscape and quality organization
• Veeva Vault
• Project Management About the department
Located in Bagsværd, Denmark, the department, Inspection Office is a highly specialized area where you will join a team of 22 highly skilled, ambitious, and motivated specialists with the responsibility for handling Recalls, GMP inspections and notified body audits in as well as responsibility for the corporate recall, batch records, review and release processes. We have a close collaboration with our stakeholders globally in Novo Nordisk spanning across manufacturing sites, affiliate offices and regulatory affairs, as well as with health authorities around the world.
You will be part of a team of six dedicated colleagues and report to the Recalls Senior Manager. The team is a part of Quality Inspection Office. Working at
At , 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 to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. Contact
For further information, please contact Julie Månsson, +. Deadline
23 June 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 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.
If so, apply now!
The position
We are looking for an experienced colleague to take up the position as Quality Specialist and Process Manager of the Recall process.
In this role, you will be responsible for the Novo Nordisk Recall process and global procedures, serving as the process expert for the project replacing our current IT system for handling recalls. You will collaborate closely with the colleagues in the Recalls team to continuously improve processes, training, and collaboration with internal stakeholders and Health Authorities. Key responsibilities include:
• Overseeing corporate procedures and ensuring process performance, compliance, and improvement activities within recalls.
• Managing regulatory requirements and compliance signals.
• Acting as the process expert for the new IT system handling recalls.
• Monitoring and measuring process performance using relevant metrics and KPIs.
• Supporting the organization with respect to the Recall process during global inspections.
• Mentoring and supporting colleagues in the recall process. Qualifications
As a person you are analytical, with a calm and professional authority and have a passion for process improvement. We expect you to be a team player and have a natural interest in quality processes, authority requirements and our obligations to patients world-wide.
To be successful in this role, you need the following:
• Several years of experience working in the quality area in the pharmaceutical industry and have profound knowledge of GMP and Quality Management Systems
• An academic degree in engineering, pharmaceutical sciences, or a related natural science discipline
• Experience in working with product defect investigations or recall situations
• You must be fluent in English - both written and spoken
• Good communication and facilitation skills Preferably you have experience with:
• Audits & Inspections in the pharmaceutical industry
• Process landscape and quality organization
• Veeva Vault
• Project Management About the department
Located in Bagsværd, Denmark, the department, Inspection Office is a highly specialized area where you will join a team of 22 highly skilled, ambitious, and motivated specialists with the responsibility for handling Recalls, GMP inspections and notified body audits in as well as responsibility for the corporate recall, batch records, review and release processes. We have a close collaboration with our stakeholders globally in Novo Nordisk spanning across manufacturing sites, affiliate offices and regulatory affairs, as well as with health authorities around the world.
You will be part of a team of six dedicated colleagues and report to the Recalls Senior Manager. The team is a part of Quality Inspection Office. Working at
At , 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 to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. Contact
For further information, please contact Julie Månsson, +. Deadline
23 June 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 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.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- 11.06.2024
- Øvrige
- Bagsværd