GCP Quality Partner

Are you passionate about Quality for clinical development and committed to ensuring Excellence in Quality and regulatory compliance? LEO Pharma is looking for a skilled and proactive GCP Quality Partner to join our Global Quality team. If you have a deep understanding of Good Clinical Practice (GCP) and are motivated to contribute to assuring quality for clinical trials, we would love to hear from you! 

At LEO Pharma, we are global leaders in medical dermatology. We have 115 years' experience in bringing innovation to healthcare. And we are eager to do much more. Each year, close to 100 million people have a better day because of our medicine. 

Your Role:  

As a GCP Quality Partner, you will play a vital role in ensuring LEO Pharma remains compliant with external GCP regulations while supporting the optimization and development of our Quality Management System (QMS). You will collaborate closely with internal and external stakeholders to provide quality expertise, ensure inspection readiness, and contribute to advancing our clinical development processes. 

Your responsibilities will include:   

• Ensuring compliance with external GCP regulatory requirements and maintaining quality standards that align with global industry practices. 

• Approving QMS documentation, including deviations, CAPAs, and procedures. 

• Acting as a host during GCP sponsor inspections, supporting preparation, and ensuring effective follow-up. 

• Reviewing audit reports by external auditors and collaborating on CAPA planning and execution. 

• Managing and qualifying GCP vendors, including conducting quality meetings and ensuring issues are resolved. 

• Supporting regulatory and quality-driven projects, including the assessment and integration of new regulatory requirements. 

• Providing expert GCP guidance and advice to stakeholders on complex issues related to clinical trials. 

• Delivering GCP compliance training and coaching to key stakeholders across LEO Pharma. 

• Contributing to the Quality Management Review process and optimizing quality processes within your area of responsibility. 

• Driving collaboration and alignment with internal stakeholders in Global Clinical Development and Global Quality teams. 

Your Qualifications 

To succeed in this role, you should bring: 

• A relevant degree in life sciences (MSc or PhD level). 

• A minimum of 8 years of experience in the life sciences industry, with strong expertise in GCP and clinical trials. 

• Comprehensive knowledge of GCP regulations and a broad understanding of the clinical development process. 

• Experience with EMA/FDA inspections is required. 

• Quality assurance, audit, and/or clinical operational experience. 

• Excellent written and verbal communication skills, with the ability to train and guide stakeholders effectively. 

• Fluency in English 

• Strong knowledge of GCP compliance and its application to processes, systems, and clinical trials. 

• Analytical mindset and problem-solving skills to assess risks and enable effective decision-making. 

• Collaborative and communicative, with the ability to navigate cross-functional relationships and influence stakeholders effectively. 

• Knowledge of other GxP domains will be an advantage as the department is responsible for GVP, GMP/GDP and GCP.  

Contact and Application 

You do not need to upload a cover letter, but feel free to add a few sentences in your resume or CV on why this position has your interest. 

Your New Team 

You will join our Global Quality team, a group of highly skilled professionals committed to maintaining the highest standards in GCP compliance. The team works closely with Global Clinical Development as well as other essential functions, fostering a collaborative and trust-based environment. You can look forward to working alongside dedicated experts who are willing to share their knowledge and support one another in achieving common goals. Together, we ensure the success of clinical development processes and uphold LEO Pharma’s reputation for quality and excellence.