Good Clinical Practice/GCP Auditor – Principal/Senior Professional
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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 GCP auditor you will have an important role to safeguard the journey.
You have a unique chance to be part of Global Quality at LEO Pharma. In the Global Quality you will get the opportunity to make a significant difference for people with serious skin diseases all over the world. You will have a strong influence on the quality of our clinical processes, CROs and trial sites in our clinical development programmes.
Global Quality Audits is responsible for auditing activities within all GxP areas incl. GCP. You will join a department that have an audit corps of highly skilled auditors that work globally.
The job
As Quality GCP Auditor, you contribute to the audit risk assessment oversight and perform audit within the GCP/GCLP area of clinical processes, explorative trials, Phase 1-IV trials, CRO’s including, but not limited to Central Laboratories, special laboratories, vendors used for GCP activities such as data management, statistics and monitoring
You represent the Quality Assurance department in high complex projects ensuring Global Audit strategy and potential be engage within due diligence activities, if needed.
You impact quality within existing and successful products as well as our exciting product
pipeline where biologics are of growing importance. You master the ability to have eye for the details and at the same time see the big picture. Your analytical skills and structured approach ensure a solid audit agenda and audit conduct. Your communication skills ensure that the audit is perceived by stakeholders as a learning session and that the audit report can be clearly understood by people that did not attend the audit. The Veeva Vault system is used to control the audit process.
You will travel world-wide approx. 50 – 60 days a year.
Further some of your key responsibilities:
Your qualifications
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, global perspective and 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.
You will join 17 enthusiastic and very experienced and certified Quality Lead Auditors, one Business Analyst, and a QMS project QA located at offices in Ballerup, Denmark and Segrate, Italy. Together we are responsible for conducting audits within all GXP domains globally at LEO entities as well as its suppliers. Quality in a business-related context is part of our common DNA. As such, we strive to challenge and drive the Quality path forward to ensure the success of LEO Pharma.
Please apply at our website. The deadline is 15 December 2021. Please note that we review applications on an on-going basis and aim to close the process as soon as we find the right match – Hence, the sooner you apply the better are your chances.
If you have any questions, you are very welcome to contact Eva Lysdal Maare, Senior Manager, Global Quality Audits at +45 3176 7467.
We look forward to receiving your application.
LEO Pharma has embarked on a very ambitious journey to become the world’s preferred dermatology care partner and as GCP auditor you will have an important role to safeguard the journey.
You have a unique chance to be part of Global Quality at LEO Pharma. In the Global Quality you will get the opportunity to make a significant difference for people with serious skin diseases all over the world. You will have a strong influence on the quality of our clinical processes, CROs and trial sites in our clinical development programmes.
Global Quality Audits is responsible for auditing activities within all GxP areas incl. GCP. You will join a department that have an audit corps of highly skilled auditors that work globally.
The job
As Quality GCP Auditor, you contribute to the audit risk assessment oversight and perform audit within the GCP/GCLP area of clinical processes, explorative trials, Phase 1-IV trials, CRO’s including, but not limited to Central Laboratories, special laboratories, vendors used for GCP activities such as data management, statistics and monitoring
You represent the Quality Assurance department in high complex projects ensuring Global Audit strategy and potential be engage within due diligence activities, if needed.
You impact quality within existing and successful products as well as our exciting product
pipeline where biologics are of growing importance. You master the ability to have eye for the details and at the same time see the big picture. Your analytical skills and structured approach ensure a solid audit agenda and audit conduct. Your communication skills ensure that the audit is perceived by stakeholders as a learning session and that the audit report can be clearly understood by people that did not attend the audit. The Veeva Vault system is used to control the audit process.
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 clinical trials within the GCP area through audit conduct, improving known procedures and development of new principles/high-level procedures
- Subject matter expert within GCP area with focus on how relevant regulations impact the quality level of clinical trials within the GCP area
- Represent the audit function in a leading role during Authority Inspections world-wide
- Evaluation of quality questionnaires
- Creation of training material and perform training/knowledge within Global QA.
Your qualifications
- Master’s degree in scientific subjects
- Minimum 5 years of experience within a GCP regulated area
- Audit and inspection experience are preferred
- Profound knowledge within clinical drug development activities/clinical operations/data management
- 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, global perspective and 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.
Global Quality Audits – your new team
You will join 17 enthusiastic and very experienced and certified Quality Lead Auditors, one Business Analyst, and a QMS project QA located at offices in Ballerup, Denmark and Segrate, Italy. Together we are responsible for conducting audits within all GXP domains globally at LEO entities as well as its suppliers. Quality in a business-related context is part of our common DNA. As such, we strive to challenge and drive the Quality path forward to ensure the success of LEO Pharma.
Contact and application
Please apply at our website. The deadline is 15 December 2021. Please note that we review applications on an on-going basis and aim to close the process as soon as we find the right match – Hence, the sooner you apply the better are your chances.
If you have any questions, you are very welcome to contact Eva Lysdal Maare, Senior Manager, Global Quality Audits at +45 3176 7467.
We look forward to receiving your application.
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 25.5.2021, 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
- Ballerup
- Tirsdag den 22. juni 2021
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