Quality Management Lead, GLP - Mechelen,BE/Leiden,NL/Romainville,F

Job description

Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company with offices in Europe in Belgium (Mechelen), France (Romainville), the Netherlands (Leiden) and in US, Boston.

 

We’re in the business of changing lives.  In our quest to discover and develop life-improving medicines we go where no one has ever gone before.   In every challenge we face, we see new opportunities.  We want to challenge the impossible.  We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters.  Collaborative innovators and perseverant idealists. We need the best-in-class.  In other words, we need you.    

 

We are looking for a Quality Management Lead, GLP-Mechelen,BE/Leiden,NL/Romainville,F

 

 Scope of the job

 

You will be responsible for supporting development of appropriate process for the non-clinical development area, assisting the non-clinical area in selection of appropriately qualified external vendors for GLP/GCLP activities and should ensure alignment with the current state of Regulatory Authorities’ expectations for such activities.

 

You will also be the GLP/GCLP Quality subject matter expert, and lead and manage the support in our non-clinical development activities and will work closely with the other members of the Quality Management departments to ensure consistency across the different areas. You will define, support and guide GLP/GCLP Quality activities both internally and at external service providers.

 

Your key responsibilities:

  • Provide the necessary quality support within the non-clinical development area.
  • Assists in driving change to build a culture of compliance throughout the organization.
  • Provide quality oversight and write / update or review / approve appropriate processes and quality assessment reports in the non-clinical development area to ensure regulatory requirements are met.
  • Act as the GLP Quality subject matter expert supporting the Galapagos organization.
  • Collaborate with the R&D Quality Management Department with respect to audit programs by independent auditors.  Assists the business stakeholders to ensure proper CAPA formulation.
  • Build a collaborative working relationship with the internal stakeholders and cross-functional peers.

 

Requirements

Who are you ?

The most important part of your experience will be hand on involvement with GLP activities in an outsourced environment. You have worked with GLP activities for at least 5 years and may have additional quality experience from other areas. It will be an advantage if you have auditing experience.

 

What’s in it for you ?

You will be part of a fast growing and amazing company.  As ‘make-it-happener’ you will get all the support you need to make your job successful.  At Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organizational skills. Our employees are the strength behind Galapagos, a highly motivated team, eager to maintain Galapagos’ leading position and achieve breakthroughs in pharmaceutical research. Galapagos offers a competitive remuneration package and a dynamic work environment.

 

We are Galapagos : together we can make it happen…!