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Senior Compliance Specialist, Ballerup

Created 11/04/2021
Date expired 01/27/2022
Reference 1628799062
Category Pharmaceutical
Job type Full Time
Country Denmark
City Ballerup
Zip Not specified
Salary Competitive
Do you want to be part of an exciting journey?

Do you have a strong quality mindset and want to put your robust knowledge of GCP into play to develop efficient, high-quality processes? Do you thrive working globally with many stakeholders in an innovative company? Then this job might be something for you.

LEO Pharma has set the ambitious goal to become the world's preferred dermatology care partner and to improve the quality of life for millions of patients around the world. To succeed, we invest massively in Research & Development and our pipeline and clinical activities are growing rapidly, constantly demanding a strong and continued focus on driving efficiencies and optimisations in our organisation, and that is why we need you!

If you are experienced within clinical quality assurance, trial management, data management, monitoring, or GCP auditing with a strong knowledge of GCP and looking for a job with significant impact and influence in an innovative environment, you are the perfect match!

About the job - delivering high-quality clinical processes

As Senior Compliance Specialist in Clinical Process Management your overall objective is to support the operational excellence in Global Clinical Operations and Medical Sciences by providing GCP support and developing compliant, high-quality and efficient processes in collaboration with stakeholders across the organisation. In this role you will be key in ensuring our processes are following internal and external requirements, and that the processes at the same time support a flexible and agile working environment with digitalisation of clinical trials on the agenda.

Your primary tasks will be to:
  • Being the subject matter expert within GCP, governing compliance within clinical trial processes and provide advice to support the stakeholders
  • Deliver compliant clinical process optimizations involving both our systems, tools and processes in close collaboration with line of business
  • Facilitate and participate in process improvement projects
  • Verify clinical compliance to applicable Standard Operating Procedures and regulations
  • Contribute to CAPA identification and resolution of audit findings in collaboration with the auditee and action owners ensuring global process alignment and compliance
  • Plan and drive clinical trial inspection readiness activities with line of business
  • Promote and nourish a quality mindset culture by proactively facilitate and communicate lessons learned and best practices in line of business
  • Support operational excellence through continuous stakeholder management and communication

We are offering a job with considerable individual responsibility and challenges, and a high level of visibility, as you will collaborate with a great number of stakeholders across the organization.

About you - an experienced compliance specialist

You have a master in natural or life science like Pharmacy or equivalent relevant education. Ideally, you have at least five years' hands-on working experience within the clinical drug development discipline and a solid knowledge of GCP and related regulations. Experience within clinical quality assurance, trial management, data management, monitoring, or GCP auditing is a high priority. Knowledge of vendor oversight and IT systems qualification requirements in a GCP setting will be a plus but not a requirement. Further, you demonstrate solid experience in driving and implementing process optimizations within R&D in the pharmaceutical industry.

To succeed in the job, you use your impact and pro-active can-do attitude to achieve long-lasting results, secure end-to-end thinking, and are an excellent collaborator with a supportive mindset. You are organized, detail-oriented, and quality conscious without losing the big picture. You build relationships across the organization and benefit from your excellent communication skills that enable you to bring your messages across in an easily understandable way, written and spoken.

Being part of an organization constantly developing, you must enjoy and embrace an environment of change and take a pragmatic approach to problem-solving.

About Clinical Process Management - your new department

Clinical Process Management is one of four departments in Clinical Operations Support within Global Clinical Operations. We strive to support our internal stakeholders with processes, training, and compliance to deliver high-quality clinical trials. The department consist of ten dedicated process and compliance specialists with high professional standards. The working atmosphere is busy, collegial, and informal, and as for the rest of LEO Pharma, innovation is part of everything we do.

We look forward to receiving your application before the 6th of February 2022. However, we will be screening and interviewing on an on-going basis.

For more information, please contact Trine Danø Klingberg, Head of Clinical Process Management, on +45 3126 2553.

LEO Pharma

LEO Pharma is on an exciting journey of transformation to become the world leader in dermatology. We keep the patients at the heart of everything we do, and we drive dermatology with our knowledge, collaboration and curiosity. We are at the forefront of science in developing new medicines for dermatology, and we are committed to helping people with skin diseases live more fulfilling lives.

Our people are united worldwide with strong core values and a common vision. Our shared vision and mission adapt to an ever-changing environment, while remaining true to our business strategy. Our values reflect the way we strive to increase the quality of life for patients.

Founded in 1908 and owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, setting new standards of care for people with skin conditions.

LEO Pharma is headquartered in Denmark with a global team of 6,000 people, serving 92 million patients in 130 countries.