GCP Senior QA & Lead Auditor

Application deadline:  
Location: Barcelona 08003, Barcelona, Spain 
Contract type: Permanent 
Job ID: 2010 

Would you like to play a key role and have a strong influence on the quality of our clinical processes and CROs within clinical development and operations in LEO Pharma?

Do you find it exiting to cooperate with colleagues across functional areas? Are you looking for a job where you can use your robust GCP knowledge globally, and personally impact the quality of an ambitious clinical trial agenda involving close collaboration with CROs? Then, this is the job for you!

LEO  Pharma has embarked on an ambitious journey to become the preferred dermatology care partner improving people’s lives around the world – and that is why we need you. 

In R&D Quality you will get the opportunity to shape the future and help people with skin diseases live more fulfilling lives by advancing the standard of care. You will join R&D Quality and be part of the Strategic Partnership to propel clinical trial execution within medical dermatology by supporting the continued development of auditor function within GCP.

We are looking for a seasoned professional with extensive experience in auditing clinical trials within the GCP/GCLP, and with a passion for driving compliance improvements and ensuring the highest quality standards in clinical research.

In this combined role, you will play a key role performing GCP/GCLP audits around the world and develop the GCP inspection process at LEO Pharma as Process Owner Delegate securing inspection readiness.

You will also play a role in influencing the quality level of clinical trials within the GCP and GCLP areas through audit conduct, improving known procedures, and developing new principles and high-level procedures. 

Your role
Main responsibilities

• Perform audits worldwide for clinical trials within the GCP/GCLP area
  • including explorative trials, Phase I-IV trials, suppliers, CROs, central laboratories, special laboratories, vendors, and internal GCP systems and processes
• Process Owner delegate of the GCP Inspection process  
  • developing the LEO Pharma GCP inspection process
  • co-host and operate the GCP inspection process driving preparations, execution and follow-up activities

Secondary responsibilities

• Provide quality expertise and advice to stakeholders on complex matters related to GCP
• Subject matter expert within GCP area with focus on how relevant regulations impact the quality level of clinical trials within the GCP area
• Participate in defining the audit strategy including risk assessment, and ensuring oversight and trending of the audit program for clinical trials within the GCP/GCLP area

You will be an important contributor and driver of improvement activities within the GCP Quality areas. You may also be involved in due diligence during acquisitions.

In this role you will have approximately 30-50 travel days related to audits in Europe, Americas, and Asia.

Your qualifications 
To succeed in this role, we imagine that you have the following qualifications:

• Master's degree in a relevant field (e.g., Life Sciences, Pharmacy, etc.).
• Solid experience within a GCP regulated area 
• Extensive experience (minimum 5-7 years years) in GCP auditing e.g. CROs, central- and special- laboratories, suppliers, and internal GCP systems and processes.

Preferred qualification

• Experience with Authority Inspections
• Experience in developing and implementing quality processes
• Solid experience within a GCP regulated area 
• Strong knowledge within clinical drug development activities, clinical operations, and data management and IT system validation and security
• Strong expertise in Quality Management Systems and risk assessment methodologies

As our ideal candidate, you are a team player with excellent interpersonal and networking skills. You value knowledge sharing and work effectively with others to achieve team goals. 

You have a strong understanding of fundamental business processes and their interactions, including the impact of external/internal influences on decision-making. As a self-starting and highly structured individual, you plan your own work and deliver on time. 

Joining our team offers a unique opportunity for personal and professional growth, allowing you to contribute to critical business processes.

Your new team
R&D Quality, that is part of the Corporate Quality area in the Global Quality organization, is responsible for ensuring quality in R&D activities across the entire LEO Pharma organization in RA, Safety, CMC, Clinical Operation and Development, Medical Device, and DDC, including GCP.

You will join 15 enthusiastic and very experienced colleagues – we are auditors, qualified persons and specialists within the field of responsibility of R&D Quality. 
 
Quality is in our DNA, and we strive to challenge and drive the quality path forward for the success of LEO Pharma. Our team always considers processes from end to end and values input from others.

In our informal work environment, everyone's voice is heard. We aspire to execute with excellence, be professional and ambitious, and never forget to have fun!

Contact and application
For additional information, please contact Mads Kusk, Head of R&D Quality at +4553567531.

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.

Beyond the skin
Join LEO Pharma, a global leader in medical dermatology, as we go beyond the skin to make a lasting impact.  Our innovative approach sets us apart. We are dedicated to leaving a legacy that positively impacts patients, colleagues, and our planet. In our flat structure, you'll have the power to make a visible impact, leveraging our size for versatile roles and professional growth.
At LEO Pharma, you can be yourself and be part of our passionate team.

Together, let's make a meaningful difference in the lives of millions.

For certain positions, LEO Pharma might complete a background check conducted by a third party.