Head of Global Audit, Quality - Mechelen, BE

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), Basel (Switzerland) and in the USA (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 Head of Global Audit, Quality.

 

Scope of the role

You are accountable for the leadership of overall auditing activities to ensure compliance of (external) operations with company policies, industry standards, and applicable regulations. This includes overseeing the conduct of a variety of audit activities, which may include, but not be limited to, vendor audits, internal process audits, pharmacovigilance system audits, study specific audits (e.g. investigator site, in process, pharmacy/distribution, trial master file), managing sponsor audits, inspection support, and (future) country office audits.

 

Next to the operational responsibilities you will set up the strategic direction for QA audits by providing leadership of all GxP audit functions covering GLPs, GMPs and GCPs and ensure the development, execution of a risk based audit program to fulfil (global) regulatory requirements. 

 

You will drive, promote and embed a culture of ethics, integrity and continuous improvement that will support Galapagos moving to a fully end-to-end integrated Biotech company.

Requirements

Who are you?

  • PhD or Master in a life science field (Biology, Chemistry, or Pharmaceutical sciences) with a minimum of 8 years QA experience within biotech and pharmaceutical settings.
  • A hands-on  leader with previous managerial experience who leads by example, inspires and empowers team members.
  • Strong knowledge of GLP, GMP and GCP)
  • Must have demonstrated experience with GCP auditing. Vendor audit experience in a variety of vendor types is a must.
  • Inspections and investigation experience are required.
  • Ability to maintain and create professional networks with stakeholders internally and externally.

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…!