GCP Auditor - Specialist in GCP Audits
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Bagsværd
- Quality
- Bagsværd
Do you wish to use your expertise within Clinical Development and good clinical practice (GCP) in a highly professional and engaged global environment? Do you want to use your strong quality mind-set and process optimisation skills to leverage audit conduct world-wide? Then you may be our new GCP auditor.
Being part of Novo Nordisk Quality means working with one of the world’s most successful biopharmaceutical companies.
In Quality Audits we provide assurance of patient safety, product quality and compliance. This is done by conduct of independent, objective and risk-based audits to mitigate significant surprises during health authority inspections; escalating signals, trends and recommendations to senior management and seizing opportunities to create value for Novo Nordisk using unique expertise. Here, an auditor has a high level of responsibility, exposure and interaction with people across many different countries and cultures.
About the department
GCP Audits is a department in Quality Audits with 19 GCP auditors located in Denmark and in Bangalore, India. The department has the global responsibility to audit clinical trials throughout all development phases as well as to perform affiliate, clinical research organisation (CRO), clinical laboratory and system audits worldwide. The audits help ensuring ethical conduct, safety of the trial subjects, and data integrity in all clinical research sponsored by Novo Nordisk A/S applying a risk-based approach.
Audits are conducted world-wide and approximately half of your audits is done by you as a single GCP auditor and half is conducted by a team of two GCP auditors. We are dedicated to team work, sharing audit best practices within the department and with auditors in other domains, striving to develop a consistent auditing approach at a world–class level.
The position
The position is placed in the Danish part of the GCP Audits department.
As GCP auditor you will have a high level of responsibility, and you will have a great impact on the quality of the clinical trial work. Your key responsibility is to conduct GCP audits at clinical trial sites and of Novo Nordisk affiliates and CROs involved in clinical research world-wide. Therefore, you should expect approximately 80-100 travel days annually.
You will work in a dynamic department where changes to the audit schedules require high flexibility from you.
We require that you are able to work independently. It is expected, that you have an analytical and pragmatic mind-set. As GCP auditor you will interact and communicate effectively with external and internal stakeholders at all organisational levels and across many different cultures.
Qualifications
You hold a university degree in natural or pharmaceutical sciences.
You must have previous experience as GCP auditor, or you have documented experience from clinical trials execution e.g. from trial management, monitoring, data management, biostatistics, clinical reporting or drug safety for at least 7 years. A candidate with strong knowledge of data processing in clinical trials and a flair for digital solutions would be preferred.
You have high ethical standards and are committed to the overall aim of ensuring ethical conduct, safety of trial subjects and data integrity. You have good knowledge of GCP and good documentation practice requirements, and you understand and interpret the applicable standards in the field of clinical research. You have an eye for detail, but you must also be able to be pragmatic and see the big picture.
You are open-minded, with excellent cultural awareness skills. You excel effectively in communication in English both verbal and in writing. You like to be in daily contact with different stakeholders around the world. You thrive in a dynamic and busy environment with changing priorities.
At Novo Nordisk, you will join a patient-centred culture of talented professionals. We
respect individuality and encourage you to make the most of your potential.
Contact
For further information, please contact Rikke Riisbro at +45 3079 1885 after 16-September-2019 as Rikke Riisbro will be on leave.
Recruitment process expected to take place during October 2019
Deadline
29 September 2019.
Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.
Information og data
Denne ledige stilling har jobtypen "Regnskabsmedarbejder", og befinder sig i kategorien "Økonomi og jura".
Arbejdsstedet er beliggende i Bagsværd.
Jobbet er oprettet på vores service den 29.8.2019, 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.
- Regnskabsmedarbejder
- Bagsværd
- Søndag den 29. september 2019
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