Senior Scientific GCP Advisor (Executive Level), Clinical Quality & Compliance
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Søborg
Are you an experienced Health Authority GCP Inspector dreaming of using your solid knowledge in driving the future of Clinical Quality & Compliance in Novo Nordisk? Would you like to work in an exciting environment with ample opportunities for personal development and constant interaction with diverse stakeholders across Development, Research & Early Development, our Regions, Affiliates as well as in Quality. Then this could be an opportunity for you!
I am seeking an ambitious Senior Scientific GCP Advisor at Executive level to support the Clinical Quality & Compliance Area, R&D Quality in setting the direction and enable a strong Quality Culture with all our stakeholders globally.
The position
You will be the senior level advisor within clinical development, quality & compliance to the Novo Nordisk Development, Research & Early Development organisations as well as our affiliates/regions including the leadership teams in those areas. You will be providing expert guidance and finding resolutions and mitigations for GCP compliance gaps and proactively drive GCP compliance projects. You will work with trends, risk identification and mitigation contributing to enhancing the quality and compliance internally. In this position you should also expect to represent Novo Nordisk in external engagements and forums as well as present on behalf of the company.
You will be reporting to the Head of Clinical Quality & Compliance and be part of the Clinical Quality & Compliance Leadership Team.
The Clinical Quality & Compliance Area is responsible for:
• Leading GCP inspections globally
• The Serious Breach process, evaluation, and reporting
• GCP Audit CAPA QA
• Being proactive quality partners to our stakeholders
• Contributing to clinical due diligence activities and integrations
• Supplier assessments
• Capturing, evaluating, and assessing impact of global external clinical requirements via the Clinical Issues Focus Group
• Quality Monitoring Trending of global clinical quality and compliance data and global oversight
• Review of Investigator Initiated Study protocols for GCP compliance
Qualifications
To be a successful candidate, you:
• Have a master’s degree in natural sciences (biology, chemistry or biochemistry) or in another relevant area
• Have solid experience as GCP Inspector from a Health Authority
• Have experience with drug development and GCP
• Have strong communication skills and act as a role model to ensure smooth collaboration with stakeholders at all levels
• Are proactive, curious, adaptable, solution oriented, constructive, and able to set direction, lead, and motivate to ensure quality and compliance is high on the agenda and to drive the progress of the research and development activities globally
About the department
R&D Quality is a growing, dynamic area with responsibility for assuring quality across both the Research & Early Development and Development organisation. The area consists of approximately 115 dedicated employees divided into 4 different areas. Clinical Quality & Compliance is one of the areas in R&D Quality.
You will be part of a high performing culture with focus on quality, patient safety, cross-functional collaboration, and personal development. We are passionate about reaching our ambitious goals as a team. We are proactive, curious, and courageous, always striving for keeping quality simple and we believe in developing people through trust and empowerment
Working at Novo
At Novo Nordisk we do not wait for change. We drive it. We are 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 are all working to move the needle on patient care.
Contact
To learn more about the position, please contact Lisbeth Bonefeld at [email protected] or mobile +45 30758096
Deadline
22 February 2023
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.
I am seeking an ambitious Senior Scientific GCP Advisor at Executive level to support the Clinical Quality & Compliance Area, R&D Quality in setting the direction and enable a strong Quality Culture with all our stakeholders globally.
The position
You will be the senior level advisor within clinical development, quality & compliance to the Novo Nordisk Development, Research & Early Development organisations as well as our affiliates/regions including the leadership teams in those areas. You will be providing expert guidance and finding resolutions and mitigations for GCP compliance gaps and proactively drive GCP compliance projects. You will work with trends, risk identification and mitigation contributing to enhancing the quality and compliance internally. In this position you should also expect to represent Novo Nordisk in external engagements and forums as well as present on behalf of the company.
You will be reporting to the Head of Clinical Quality & Compliance and be part of the Clinical Quality & Compliance Leadership Team.
The Clinical Quality & Compliance Area is responsible for:
• Leading GCP inspections globally
• The Serious Breach process, evaluation, and reporting
• GCP Audit CAPA QA
• Being proactive quality partners to our stakeholders
• Contributing to clinical due diligence activities and integrations
• Supplier assessments
• Capturing, evaluating, and assessing impact of global external clinical requirements via the Clinical Issues Focus Group
• Quality Monitoring Trending of global clinical quality and compliance data and global oversight
• Review of Investigator Initiated Study protocols for GCP compliance
Qualifications
To be a successful candidate, you:
• Have a master’s degree in natural sciences (biology, chemistry or biochemistry) or in another relevant area
• Have solid experience as GCP Inspector from a Health Authority
• Have experience with drug development and GCP
• Have strong communication skills and act as a role model to ensure smooth collaboration with stakeholders at all levels
• Are proactive, curious, adaptable, solution oriented, constructive, and able to set direction, lead, and motivate to ensure quality and compliance is high on the agenda and to drive the progress of the research and development activities globally
About the department
R&D Quality is a growing, dynamic area with responsibility for assuring quality across both the Research & Early Development and Development organisation. The area consists of approximately 115 dedicated employees divided into 4 different areas. Clinical Quality & Compliance is one of the areas in R&D Quality.
You will be part of a high performing culture with focus on quality, patient safety, cross-functional collaboration, and personal development. We are passionate about reaching our ambitious goals as a team. We are proactive, curious, and courageous, always striving for keeping quality simple and we believe in developing people through trust and empowerment
Working at Novo
At Novo Nordisk we do not wait for change. We drive it. We are 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 are all working to move the needle on patient care.
Contact
To learn more about the position, please contact Lisbeth Bonefeld at [email protected] or mobile +45 30758096
Deadline
22 February 2023
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 Søborg.
Jobbet er oprettet på vores service den 7.2.2023, 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
- Søborg
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