GCP Advisor
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Søborg
Are you passionate about clinical quality and do you have solid knowledge of GCP, process optimisation skills and a quality mindset? Will you bring a ‘can-do’ attitude to support high quality in the development of innovative treatments for patients? If yes, then you might be the GCP Advisor we are looking for.Apply now for this exciting job opportunity and join – leading global healthcare company!The position
As a GCP Advisor, you will join a dynamic and impactful area with strong opportunities for professional growth. In this role, you are expected to take ownership and play a key part in setting the right quality standards across the global organisation. You will work in small, collaborative teams that proactively support clinical functions worldwide, ensuring that consistently complies with GCP and other relevant internal and external requirements.
Some of your main responsibilities will include:
• Acting as a Clinical Quality partner to key projects and business areas
• Reviewing and approving audit CAPA plans
• Performing vendor assessments
• Managing Serious Breaches, Clinical Deviations, and Change Controls
• Participating in cross-functional Clinical Quality initiatives
• Supporting improvement projects
• Assisting the GCP inspection team during regulatory inspectionsThe open position is based in Søborg, but you will be required to collaborate closely with colleagues working remotely across various time zones. Therefore, flexibility and adaptability are essential.Qualifications
To succeed in this role, you need:
- An academic degree in pharmacy, medicine, science or or a related field
- At least 5 years of experience in GCP and other relevant regulations within clinical research and drug development
- Experience in clinical quality assurance, trial management/monitoring, or GCP audits
- Excellent command of written and spoken EnglishOn a personal level, you take a positive and pragmatic approach to problem solving and you are eager to create, optimise and simplify processes around you. You are proactive, courageous and have strong communication and interpersonal skills. Furthermore, you are organised, detail-oriented without losing the big picture and quality-conscious as well as curious by nature. In addition, you can work independently and as part of a team and you thrive working across departments in an international organisation.About the Department
Clinical Quality Assurance (QA) is one of four sister departments in Clinical Quality, which is part of R&D (Research and Development) Quality in . We play a vital role in supporting the drug development process by ensuring high quality as well as fit-for-purpose processes.
In , we have an ambitious drug development program, and we work in a global setting with focus on delivering viable products that make a difference to patients and ultimately benefit society.Working at
is its people. We know that life is anything but linear, and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at is working toward something bigger than ourselves, and it’s a collective effort. relies on the joint potential and collaboration of its more than 50,000 employees. Together, we go further. Together, we’re life changing.Contact
For further information, please contact Najat EL Bariaki, Manager at +.Deadline
03 August 2025.You do not need to attach a cover letter to your application, but do remember to include a few sentences about why you are applying in your CV. Please also avoid the use of photos in your CV.We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.At we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
As a GCP Advisor, you will join a dynamic and impactful area with strong opportunities for professional growth. In this role, you are expected to take ownership and play a key part in setting the right quality standards across the global organisation. You will work in small, collaborative teams that proactively support clinical functions worldwide, ensuring that consistently complies with GCP and other relevant internal and external requirements.
Some of your main responsibilities will include:
• Acting as a Clinical Quality partner to key projects and business areas
• Reviewing and approving audit CAPA plans
• Performing vendor assessments
• Managing Serious Breaches, Clinical Deviations, and Change Controls
• Participating in cross-functional Clinical Quality initiatives
• Supporting improvement projects
• Assisting the GCP inspection team during regulatory inspectionsThe open position is based in Søborg, but you will be required to collaborate closely with colleagues working remotely across various time zones. Therefore, flexibility and adaptability are essential.Qualifications
To succeed in this role, you need:
- An academic degree in pharmacy, medicine, science or or a related field
- At least 5 years of experience in GCP and other relevant regulations within clinical research and drug development
- Experience in clinical quality assurance, trial management/monitoring, or GCP audits
- Excellent command of written and spoken EnglishOn a personal level, you take a positive and pragmatic approach to problem solving and you are eager to create, optimise and simplify processes around you. You are proactive, courageous and have strong communication and interpersonal skills. Furthermore, you are organised, detail-oriented without losing the big picture and quality-conscious as well as curious by nature. In addition, you can work independently and as part of a team and you thrive working across departments in an international organisation.About the Department
Clinical Quality Assurance (QA) is one of four sister departments in Clinical Quality, which is part of R&D (Research and Development) Quality in . We play a vital role in supporting the drug development process by ensuring high quality as well as fit-for-purpose processes.
In , we have an ambitious drug development program, and we work in a global setting with focus on delivering viable products that make a difference to patients and ultimately benefit society.Working at
is its people. We know that life is anything but linear, and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at is working toward something bigger than ourselves, and it’s a collective effort. relies on the joint potential and collaboration of its more than 50,000 employees. Together, we go further. Together, we’re life changing.Contact
For further information, please contact Najat EL Bariaki, Manager at +.Deadline
03 August 2025.You do not need to attach a cover letter to your application, but do remember to include a few sentences about why you are applying in your CV. Please also avoid the use of photos in your CV.We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.At we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 1.7.2025, 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.
- Øvrige
- Søborg
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