Senior Quality Specialist with passion for GCP
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Ballerup
Would you like to play a key role in LEO Pharma’s ambitious clinical trial programme? Do you find it exiting to cooperate with colleagues across functional areas? Are you looking for a job where you can use your robust GCP knowledge globally and personally impact the quality of an ambitious clinical trial agenda? Then, this is the job for you!
You will be part of the newly established GCP QA team where you will be working closely together with internal and external stakeholders to ensure LEO Pharma’s processes and systems are maintained and in line with regulatory expectations and industry best practice.
In overview your primary responsibilities will be to:
You will work across the global organisation and be in contact with colleagues in various departments and functions. As part of this, you can expect minimum 10 travel days per year to meet colleagues and partners.
The job is with reference to the Senior Manager of the department.
The Development Quality department consists of great QA colleagues within CMC Development, Device Development, Pharmacovigilance and Clinical Development.
We are striving to safeguard our patients and to improve the quality of LEO Pharma processes. We are driven by integrity and compliance.
In our team, we discuss and investigate to find the best solutions for our patients, for LEO Pharma and for our stakeholders. Strong characteristics of our department are that we always try to see processes from end to end and that we are open to input.
You will join a team of dedicated and energetic specialists in an informal work environment where everyone is heard.
Our aspirations are to excel at executing, being professional and ambitious, while never forgetting to have fun!
You have a background in life science, strong GCP experience and thorough knowledge in clinical trials.
You should be familiar with quality regulations within GCP and have a broad understanding of the entire clinical development process.
If you have quality assurance and/or audit experience, it will naturally benefit your application.
You are a “self-starting” and highly structured person that is able to plan your own work and get things finished on time. Working cross-organisational takes strong communication and collaboration skills – in combination with an open-minded and pragmatic approach that enables you to understand and respect different views and opinions.
You have excellent written and oral communication skills in English. You possess the ability to define risk as it relates to specific non-conformances or trends and work with colleagues to mitigate identified risks.
By joining the team you will have a unique opportunity for personal and professional development and to contribute to business critical processes. Furthermore, you will have the possibility to have an impact on the department and influence on your own job.
We look forward to receiving your application.
Get more information from Senior Manager Louise Groth Persson +45 53 80 05 91.
The job
You will be part of the newly established GCP QA team where you will be working closely together with internal and external stakeholders to ensure LEO Pharma’s processes and systems are maintained and in line with regulatory expectations and industry best practice.
In overview your primary responsibilities will be to:
- Provide quality expertise and advice to stakeholders on matters related to GCP
- Support the continuous improvement of LEO Pharma’s Quality Management System
- Coordinate, support and follow-up on regulatory GCP inspections
- Communicate and assess the impact of regulatory/industry practice changes on stakeholder systems, LEO Pharma clinical trials, data and patients
- Support training in relevant GCP regulation and LEO Pharma Quality Management System
- Contribute and lead GCP improvement projects
- Approval of QMS documentation such as deviations and CAPAs
You will work across the global organisation and be in contact with colleagues in various departments and functions. As part of this, you can expect minimum 10 travel days per year to meet colleagues and partners.
The job is with reference to the Senior Manager of the department.
About the department
The Development Quality department consists of great QA colleagues within CMC Development, Device Development, Pharmacovigilance and Clinical Development.
We are striving to safeguard our patients and to improve the quality of LEO Pharma processes. We are driven by integrity and compliance.
In our team, we discuss and investigate to find the best solutions for our patients, for LEO Pharma and for our stakeholders. Strong characteristics of our department are that we always try to see processes from end to end and that we are open to input.
You will join a team of dedicated and energetic specialists in an informal work environment where everyone is heard.
Our aspirations are to excel at executing, being professional and ambitious, while never forgetting to have fun!
Your qualifications
You have a background in life science, strong GCP experience and thorough knowledge in clinical trials.
You should be familiar with quality regulations within GCP and have a broad understanding of the entire clinical development process.
If you have quality assurance and/or audit experience, it will naturally benefit your application.
You are a “self-starting” and highly structured person that is able to plan your own work and get things finished on time. Working cross-organisational takes strong communication and collaboration skills – in combination with an open-minded and pragmatic approach that enables you to understand and respect different views and opinions.
You have excellent written and oral communication skills in English. You possess the ability to define risk as it relates to specific non-conformances or trends and work with colleagues to mitigate identified risks.
What are you getting in return?
By joining the team you will have a unique opportunity for personal and professional development and to contribute to business critical processes. Furthermore, you will have the possibility to have an impact on the department and influence on your own job.
We look forward to receiving your application.
Interested?
Get more information from Senior Manager Louise Groth Persson +45 53 80 05 91.
Information og data
Denne ledige stilling har jobtypen "Produktspecialist", og befinder sig i kategorien "Kommunikation, marketing, salg".
Arbejdsstedet er beliggende i Ballerup.
Jobbet er oprettet på vores service den 14.5.2021, 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.
- Produktspecialist
- Ballerup
- Tirsdag den 15. juni 2021
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