Senior Compliance Specialist (GCP) - Clinical Process Management, Ballerup

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 an experienced Compliance Specialist with a strong knowledge of GCP and drug development processes, and you are looking for a job where you can unfold all your skills in a role with great 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
• Ensure inspection readiness including adherence to processes and legislation hereunder coordinate, support, participate and follow-up
• Promote and nourish a quality mindset by proactively facilitate and communicate lessons learned and best practices
• 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 required. Knowledge of vendor oversight, data management, and IT systems 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 nine 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 March 8th 2021. 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.