GCP Senior QA & Lead Auditor

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!