Principal GLP and/or GCP Auditor
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Ballerup
Global Quality Audits
LEO Pharma has embarked on a very ambitious journey to become the world’s preferred dermatology care partner and as GLP/GCP auditor you will have an important role to safeguard this journey.
You have a unique chance to be part of Global Quality at LEO Pharma. In Global Quality you will get the opportunity to make a significant difference for people with serious skin diseases all over the world. This job will bring you will represent LEO and making audits world-wide.
Global Quality Audits is responsible for auditing activities within all GxP areas incl. GLP & GCP. You will join a department that have auditors located in Italy as well as in Ballerup, Denmark.
The job
As Principal GLP/GCP Auditor, you will represent the Audit function ensuring fulfillment of the Global Audit strategy and contributing to the audit risk assessment oversight within the GLP and GCLP areas. This include audits of non-clinical GLP studies, GLP facility audits, as well as audits of special laboratories and Central laboratories used in Clinical Trials.
You will impact quality within the existing product portfolio as well as our exciting product
pipeline where biologics are of growing importance.
You will travel world-wide approx. 50 – 60 days a year.
Further some of your key responsibilities:
- Act as Lead Auditor with the authority to assess and influence directly on quality level of non-clinical development activities as well as within clinical trials through audit conduct
- Expert within GLP/GCLP area with focus on assuring compliance with relevant regulations
- Continuous improvement of our audit system and development of procedures to ensure efficient and robust audit performance
- Represent the audit function in a leading role during Authority Inspections world-wide
- Evaluation of pre-assessment quality questionnaires, conduct of pre-qualification audit and participate in due diligence activities in connection with acquisitions
- Creation of training material and perform training/knowledge within Global Quality Audits
Your qualifications
- Master’s degree in scientific subjects
- Minimum 5-10 years of experience within a GLP regulated area
- Audit and inspection experience are preferred
- Profound knowledge within non-clinical development activities/laboratory services used for development of pharmaceutical drugs
- Excellent communication skills
- Fluency in English is a must
It is expected that you will live up to LEO values: Integrity, Customer focus, Innovation, Passion and Adaptability.
The seniority of the auditor role demands complex decision making, eye for details, proactivity and global perspective and a strong strategic mindset.
Join our mission to help more people achieve healthy skin
Hundreds of millions of people around the globe are suffering from an untreated skin disease. Helping these people to get a better life is what LEO Pharma is all about. By understanding their needs and wishes we will improve existing treatments and break new land to uncover the solutions of tomorrow.
By joining LEO Pharma you will get the opportunity to create results, develop yourself among highly skilled colleagues while taking on our quest to become the preferred dermatology care partner improving people’s lives around the world and at the same time create profitable growth.
Contact and application
Please send your application and CV in English before August 3, 2020.
Information og data
Denne ledige stilling har jobtypen "Regnskabsmedarbejder", og befinder sig i kategorien "Økonomi og jura".
Arbejdsstedet er beliggende i Ballerup.
Jobbet er oprettet på vores service den 2.7.2020, 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
- Ballerup
- Mandag den 03. august 2020
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