Principal GCP Advisor to Drive Digital Quality Excellence
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Søborg
Looking for a dynamic and challenging role within clinical process management? Do you thrive when using your expertise in GCP, process optimisation skills and quality mind-set in a highly professional and engaged global environment? And can you be our subject matter expert for our digitalisation teams in transforming our clinical processes while ensuring compliance? If so, then we have the perfect opportunity for you in R&D Clinical Quality!Apply now and join a great team, where focus is on collaboration, individual development and complex problem solving.The position
As a Principal GCP Advisor in our Clinical QMS department, your primary responsibility is to ensure regulatory compliance when transforming our written standard operating procedures (SOP’s) into seamless digital / system-based processes. You will furthermore be performing as a quality and process advisor to our Corporate Vice President for R&D Quality and supporting our colleagues working within the Establish Clinical Evidence process by ensuring direction for compliance with GCP and regulatory requirements. Your continuous focus on quality improvement will be an essential aspect of your job.Your main responsibilities will include:• Supporting digitalisation of key processes and procedures
• Verifying and approving Standard Operating Procedures (SOPs) and ensuring compliance with external & internal requirements
• Ensuring global consistency and compliance in clinical development processes through process documentation, information sharing, and guidance
• Being the quality partner for improvement projects
• Providing support to stakeholders inside and outside R&D Quality during GCP inspections as applicable
• Attending stakeholder meetings and raise/present/discuss relevant quality concerns
• Handling and processing external clinical requirements impacting the clinical area
You will be part of a dynamic and hybrid team with colleagues working from Denmark and India. Preferably this position is placed at our HQ in Søborg, Denmark, but a virtual option might be available for the right candidate. The position offers high impact, flexibility, and you are expected to take ownership and responsibility for setting the right quality level in the global organisation.QualificationsWe expect you to have:• A master degree in nursing, pharmacy, medicine, science or similar.
• A strong command of written and spoken English.
• At least 12 years of experience in clinical research and drug development, as well as a subject matter expertise of GCP and other relevant regulations such as the EMA Guideline on computerised systems and electronic data in clinical trials.
• Minimum 4 years’ experience with digitalization of processes that minimizes risk through design and focus on quality that matters is required.
• Experience within clinical quality assurance, trial management/monitoring, or GCP Audits is required.
• Solid experience in verifying and approving SOPs and interpreting GCP, and experience in managing compliance within clinical development
In addition, we are looking for someone who works independently, leveraging strong GCP knowledge and being updated with changing regulations. We expect you to be able to collaborate effectively with cross-functional teams and stakeholders, and therefore, it is important that you possess excellent communication and presentation skills. You have a proactive mindset with a focus on continuous quality improvement, and a pragmatic approach to problem solving and strong ambition to create, optimize and simplify processes.
About the department
The Clinical Quality Management System (QMS) department is one of four sister departments in Clinical Quality, which is part of R&D Quality at . We play a vital role in supporting the drug development process to ensure high quality as well as fit-for-purpose processes and procedures. At , 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
At , we do not wait for change. We drive it. We are a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development to manufacturing, marketing and sales – we are all working to move the needle on patient care.ContactFor further information, please contact Kate Bruun Lunding on +or get to know us better by visiting
31 March, 2025.You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo 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 Principal GCP Advisor in our Clinical QMS department, your primary responsibility is to ensure regulatory compliance when transforming our written standard operating procedures (SOP’s) into seamless digital / system-based processes. You will furthermore be performing as a quality and process advisor to our Corporate Vice President for R&D Quality and supporting our colleagues working within the Establish Clinical Evidence process by ensuring direction for compliance with GCP and regulatory requirements. Your continuous focus on quality improvement will be an essential aspect of your job.Your main responsibilities will include:• Supporting digitalisation of key processes and procedures
• Verifying and approving Standard Operating Procedures (SOPs) and ensuring compliance with external & internal requirements
• Ensuring global consistency and compliance in clinical development processes through process documentation, information sharing, and guidance
• Being the quality partner for improvement projects
• Providing support to stakeholders inside and outside R&D Quality during GCP inspections as applicable
• Attending stakeholder meetings and raise/present/discuss relevant quality concerns
• Handling and processing external clinical requirements impacting the clinical area
You will be part of a dynamic and hybrid team with colleagues working from Denmark and India. Preferably this position is placed at our HQ in Søborg, Denmark, but a virtual option might be available for the right candidate. The position offers high impact, flexibility, and you are expected to take ownership and responsibility for setting the right quality level in the global organisation.QualificationsWe expect you to have:• A master degree in nursing, pharmacy, medicine, science or similar.
• A strong command of written and spoken English.
• At least 12 years of experience in clinical research and drug development, as well as a subject matter expertise of GCP and other relevant regulations such as the EMA Guideline on computerised systems and electronic data in clinical trials.
• Minimum 4 years’ experience with digitalization of processes that minimizes risk through design and focus on quality that matters is required.
• Experience within clinical quality assurance, trial management/monitoring, or GCP Audits is required.
• Solid experience in verifying and approving SOPs and interpreting GCP, and experience in managing compliance within clinical development
In addition, we are looking for someone who works independently, leveraging strong GCP knowledge and being updated with changing regulations. We expect you to be able to collaborate effectively with cross-functional teams and stakeholders, and therefore, it is important that you possess excellent communication and presentation skills. You have a proactive mindset with a focus on continuous quality improvement, and a pragmatic approach to problem solving and strong ambition to create, optimize and simplify processes.
About the department
The Clinical Quality Management System (QMS) department is one of four sister departments in Clinical Quality, which is part of R&D Quality at . We play a vital role in supporting the drug development process to ensure high quality as well as fit-for-purpose processes and procedures. At , 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
At , we do not wait for change. We drive it. We are a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development to manufacturing, marketing and sales – we are all working to move the needle on patient care.ContactFor further information, please contact Kate Bruun Lunding on +or get to know us better by visiting
31 March, 2025.You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo 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 12.3.2025, 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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