GCP Domain Expert
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Are you looking for an exciting opportunity to utilise your passion for Good Clinical Practice (GCP), quality and compliance and do you want to make an impact and set the direction for future GCP audits? Come join us on our exciting journey to make audits that matter as GCP Domain Expert in Novo Nordisk Quality Audits! You will become part of a purpose driven company and be part of a life-changing career! The position
The GCP Domain Expert will report to Vice President of Good Laboratory Practice (GLP) & GCP Audits and be part of the GLP & GCP Audit management team. Together we will set the right quality level and direction for future GLP & GCP audits and ensure we create large value to the organisation.
Your main responsibilities will be to:
• Carry out complex audits
• Facilitate knowledge sharing and ensure alignment of findings and ratings
• Drive audit competency development
• Monitor, identify and communicate regulatory and industry trends and signals
• Drive the risk and planning process for GCP audits
• Develop and maintain the GCP Audit process
• Provide advice and support to lead auditors, management and key stakeholders We have a no blame culture, where mistakes simply provide us learning opportunities, and you will be taking active part in developing our culture and great team spirit. You will have high level exposure and you will interact with stakeholders and colleagues across many different countries and cultures, hence personal integrity is important to do a successful job. Furthermore, it is essential that you maintain a substantial network, attends relevant conferences, and provide debriefs to the organisation of significant industry trends. Because of the broad knowledge that Quality gives, you have a lot of options within the organization. The position is placed in Denmark and some travelling is expected. Qualifications
We are looking for a candidate who have extensive GCP and quality experience, and drive simplicity and process improvements by digitalization.
To succeed in this role, you:
• Hold a Masters’ degree with a scientific focus
• Have extensive experience within GCP in the pharmaceutical industry
• Are experienced in setting directions and identifying compliance trends and reporting to senior management
• Are keen to share your knowledge of GCP, compliance, quality management and best practices concerning audits and inspections in the industry
• Are fluent in English
If you have been an auditor or an inspector for medical authorities, it will be seen as an advantage.
As a person you are open-minded, positive, with the collaborative and pragmatic approach that compliance can be obtained by different solutions. Your excellent leadership competencies ensure engagement and involvement of the right people to ensure a successful outcome of a given assignment.
You have excellent communication skills and are experienced in conveying messages and presenting in internal and external fora. You connect easily with colleagues and stakeholders at all levels and across all cultures and can strengthen intercultural communication and interaction and to treat stakeholders in a respectful manner. About the department
Novo Nordisk Quality Audits function is part of Novo Nordisk Quality Organisation, the highest-ranking decision body in our company regarding quality. Quality Audits is an independent function that conduct independent, risk based, and objective audits. We provide assurance of patient safety; product quality and compliance and we fight for simplicity.
GLP & GCP Audits are a global team of 25 great, dedicated, specialized colleagues located in India, Denmark, US and Canada. We conduct various types of audits within GLP, GCLP and GCP, including supplier audits, process audits and investigator site audits. 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 Charlotte Manniche at +45 30753761
Deadline
23 July 2023
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.
The GCP Domain Expert will report to Vice President of Good Laboratory Practice (GLP) & GCP Audits and be part of the GLP & GCP Audit management team. Together we will set the right quality level and direction for future GLP & GCP audits and ensure we create large value to the organisation.
Your main responsibilities will be to:
• Carry out complex audits
• Facilitate knowledge sharing and ensure alignment of findings and ratings
• Drive audit competency development
• Monitor, identify and communicate regulatory and industry trends and signals
• Drive the risk and planning process for GCP audits
• Develop and maintain the GCP Audit process
• Provide advice and support to lead auditors, management and key stakeholders We have a no blame culture, where mistakes simply provide us learning opportunities, and you will be taking active part in developing our culture and great team spirit. You will have high level exposure and you will interact with stakeholders and colleagues across many different countries and cultures, hence personal integrity is important to do a successful job. Furthermore, it is essential that you maintain a substantial network, attends relevant conferences, and provide debriefs to the organisation of significant industry trends. Because of the broad knowledge that Quality gives, you have a lot of options within the organization. The position is placed in Denmark and some travelling is expected. Qualifications
We are looking for a candidate who have extensive GCP and quality experience, and drive simplicity and process improvements by digitalization.
To succeed in this role, you:
• Hold a Masters’ degree with a scientific focus
• Have extensive experience within GCP in the pharmaceutical industry
• Are experienced in setting directions and identifying compliance trends and reporting to senior management
• Are keen to share your knowledge of GCP, compliance, quality management and best practices concerning audits and inspections in the industry
• Are fluent in English
If you have been an auditor or an inspector for medical authorities, it will be seen as an advantage.
As a person you are open-minded, positive, with the collaborative and pragmatic approach that compliance can be obtained by different solutions. Your excellent leadership competencies ensure engagement and involvement of the right people to ensure a successful outcome of a given assignment.
You have excellent communication skills and are experienced in conveying messages and presenting in internal and external fora. You connect easily with colleagues and stakeholders at all levels and across all cultures and can strengthen intercultural communication and interaction and to treat stakeholders in a respectful manner. About the department
Novo Nordisk Quality Audits function is part of Novo Nordisk Quality Organisation, the highest-ranking decision body in our company regarding quality. Quality Audits is an independent function that conduct independent, risk based, and objective audits. We provide assurance of patient safety; product quality and compliance and we fight for simplicity.
GLP & GCP Audits are a global team of 25 great, dedicated, specialized colleagues located in India, Denmark, US and Canada. We conduct various types of audits within GLP, GCLP and GCP, including supplier audits, process audits and investigator site audits. 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 Charlotte Manniche at +45 30753761
Deadline
23 July 2023
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 1.6.2023, 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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