GCP Auditor / Clinical Quality Manager
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Hørsholm
GCP Auditor / Clinical Quality Manager
The position
In this exciting position, your quality competencies and experience will come into play as a Lead Auditor primarily within the field of GCP, but also with an interest in GVP and related computerized system processes. You will be responsible for performing investigator site audits and supplier audits as well as internal GCP audits, on your own or in close collaboration with other Lead Auditors in ALK.
In addition, you will act as QA partner to the Global Pharmacovigilance and Clinical Development organisation.
If you enjoy using your professional and personal skills to obtain results together with internal and external stakeholders, this is your next position.
Fields of responsibilities
Your preferred professional qualifications
Your personal qualifications
Languages:
Travelling days:
We offer
ALK provides a dynamic and pleasant work environment, complete with inspiring and challenging assignments. The results of your efforts will be significant throughout the organization and you will be able to actively influence and challenge the status quo. Our flat structures attract independent individuals who like to feel the progress of the business and enjoy being close to the decision-making process. You will be part of an engaged and informal team who values skill and knowledge creation. We consider our pioneering spirit coupled with our trustworthiness our winning formula. ALK is a health focused organization and our offices offer a green view of the DTU Science Park in Hørsholm.
Application deadline
25. January 2021
Contact
For further information on the position please contact Siren Jenssen Østerberg, Senior Director Global Quality Clinical & Markets, tlf: +45 5089 9540.
The position
In this exciting position, your quality competencies and experience will come into play as a Lead Auditor primarily within the field of GCP, but also with an interest in GVP and related computerized system processes. You will be responsible for performing investigator site audits and supplier audits as well as internal GCP audits, on your own or in close collaboration with other Lead Auditors in ALK.
In addition, you will act as QA partner to the Global Pharmacovigilance and Clinical Development organisation.
If you enjoy using your professional and personal skills to obtain results together with internal and external stakeholders, this is your next position.
Fields of responsibilities
- Performing audits, hereunder planning, execution, reporting and follow up
- Supplier management hereunder qualification of external collaborators and suppliers
- Evaluation of potential new collaborators in connection to ALKs Growth Strategy
- Represent and support the Global Pharmacovigilance and Clinical Development organisation during regulatory inspections
- Ensure regulatory surveillance for GCP and impact to the Quality and auditing area
Your preferred professional qualifications
- M.Sc. within nature science or similar
- Experience as Lead Auditor within clinical development and/or pharmacovigilance (internal audits of HQ and affiliates and external audits of collaborators and suppliers)
- 5+ years of experience within clinical development regulated areas including experience with Quality Management Systems and tools
Your personal qualifications
- Relation builder and team player, working respectfully across different cultures with flexibility
- Proactive and takes initiative and actively seeks influence and initiate actions on own initiative
- Strong cross-cultural communication skills verbally as well as written. Produces written material that is clear, fluent and easy to understand
Languages:
- Danish and English fluent (verbally and written).
Travelling days:
- Approximately 50 travelling days a year would wide can be expected.
We offer
ALK provides a dynamic and pleasant work environment, complete with inspiring and challenging assignments. The results of your efforts will be significant throughout the organization and you will be able to actively influence and challenge the status quo. Our flat structures attract independent individuals who like to feel the progress of the business and enjoy being close to the decision-making process. You will be part of an engaged and informal team who values skill and knowledge creation. We consider our pioneering spirit coupled with our trustworthiness our winning formula. ALK is a health focused organization and our offices offer a green view of the DTU Science Park in Hørsholm.
Application deadline
25. January 2021
Contact
For further information on the position please contact Siren Jenssen Østerberg, Senior Director Global Quality Clinical & Markets, tlf: +45 5089 9540.
Information og data
Denne ledige stilling har jobtypen "Regnskabsmedarbejder", og befinder sig i kategorien "Økonomi og jura".
Arbejdsstedet er beliggende i Hørsholm.
Jobbet er oprettet på vores service den 6.1.2021, 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
- Hørsholm
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