GCP Advisor Specialist
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Søborg
Do you dream of using your GCP knowledge, process optimisation skills and quality mind-set in a highly professional and engaged global environment? Do you have a ‘can-do’ attitude, and do you want to support high quality in the development of innovative treatments for patients? Then read more and apply now to become our new GCP Advisor Specialist.
The position
The open position is within our Clinical Compliance department, where we provide comprehensive support to the development area in various aspects of clinical quality. As a Quality Partner, you will collaborate closely with colleagues involved in clinical trial management, ensuring that quality standards are upheld across all phases of clinical programmes and trials. Your responsibilities will include:Acting as the single point of contact for quality-related matters Supporting clinical programmes and trials from initiation to completion Providing guidance on GCP and external requirements related to clinical trial conduct Serving as a liaison between the supported area and subject matter experts (SMEs) within Clinical Quality Participating in the network of Quality Partners within the department Contributing to improvement and optimisation initiativesOffering GCP-related advice and support to other internal stakeholders You will be part of a dynamic and hybrid team, with most colleagues based in Søborg. This position offers high impact and flexibility, and you are expected to take ownership and responsibility for setting the right quality standards within a global organisation.
Qualifications
To thrive and succeed in the role, we expect you to have:A degree in pharmacy, medicine, nursing, science or a related field At least 5 years of experience within clinical quality assurance, trial management/monitoring, or GCP audits Solid experience in clinical research and drug development, with strong knowledge of GCP and other relevant regulations Proficiency in spoken and written English In addition, experience with medical devices, phase 1 trials, co-sponsorships or digitalisation of quality processes will be considered an advantage.On a personal level, you have a positive and pragmatic approach to problem-solving and a strong desire to create, optimise, and simplify processes around you. You are proactive, courageous, and equipped with excellent communication and interpersonal skills. Organised and detail-oriented without losing sight of the bigger picture, you are also quality-conscious and naturally curious. While you thrive as a team player, you are equally comfortable working independently and enjoy collaborating across departments in an international environment.About the department
Clinical Compliance is one of four sister departments within Clinical Quality, which is part of R&D Quality at . We play a vital role in supporting the drug development process by ensuring high quality standards and implementing fit-for-purpose processes. At , we run an ambitious drug development programme and operate in a global setting with a strong focus on delivering viable products that make a meaningful difference to patients and ultimately benefit society.Clinical Quality supports the global clinical development organisation and is engaged in a wide range of quality-related activities. These include acting as Clinical Quality Partners to key projects and business areas, leading GCP inspections, providing ongoing GCP support and overall quality and compliance guidance, and reviewing and approving audit CAPA plans. We also conduct vendor assessments, support integration activities following asset acquisitions, participate in cross-organisational improvement initiatives, and share Clinical Quality and GCP knowledge throughout the organisation. Additionally, we actively seek to influence external clinical requirements to maintain and advance high-quality standards in our processes.Contact
For further information, please contact Meri Jankova at +
Deadline
22 July 2025
We will be screening, interviewing and hiring on an ongoing basis.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.
The position
The open position is within our Clinical Compliance department, where we provide comprehensive support to the development area in various aspects of clinical quality. As a Quality Partner, you will collaborate closely with colleagues involved in clinical trial management, ensuring that quality standards are upheld across all phases of clinical programmes and trials. Your responsibilities will include:
Qualifications
To thrive and succeed in the role, we expect you to have:
Clinical Compliance is one of four sister departments within Clinical Quality, which is part of R&D Quality at . We play a vital role in supporting the drug development process by ensuring high quality standards and implementing fit-for-purpose processes. At , we run an ambitious drug development programme and operate in a global setting with a strong focus on delivering viable products that make a meaningful difference to patients and ultimately benefit society.Clinical Quality supports the global clinical development organisation and is engaged in a wide range of quality-related activities. These include acting as Clinical Quality Partners to key projects and business areas, leading GCP inspections, providing ongoing GCP support and overall quality and compliance guidance, and reviewing and approving audit CAPA plans. We also conduct vendor assessments, support integration activities following asset acquisitions, participate in cross-organisational improvement initiatives, and share Clinical Quality and GCP knowledge throughout the organisation. Additionally, we actively seek to influence external clinical requirements to maintain and advance high-quality standards in our processes.Contact
For further information, please contact Meri Jankova at +
Deadline
22 July 2025
We will be screening, interviewing and hiring on an ongoing basis.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 27.6.2025, 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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