GMP Lead Auditor (Director) - Remote job - BE/CH/NL/GE

Job description

Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company with offices in Europe in Belgium (Mechelen), France (Romainville & Paris), the Netherlands (Leiden), Switzerland (Basel), Italy (Milano), Spain (Madrid), the UK (London), Germany (München), and in the US (Boston).

We are 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 GMP Lead Auditor (Director) - remote job

Scope of the job

This is a new role to expand the Galapagos internal audit team with an experienced Good Manufacturing/Distribution Practice (GMP/GDP) Auditor.

You will be responsible for defining the audit strategy in consultation with the Head of Global Audit, scheduling, conducting and reporting GMP/GDP audit within Galapagos affiliates and third parties.

You will:

  • Collaborate with the head of Global Audit, Quality Management (QM) colleagues and business partners to define the GMP and GDP audit universe at global and affiliate levels.
  • Contribute to the development and management of the Annual Master Audit Plan
  • Schedule, prepare, conduct and report audit and quality assessment activities to ensure compliance with GMP and GDP.
  • Manage CAPAs in all GxP areas related to audits.
  • Perform peer review of audit reports for colleagues
  • Analyze audit and inspection data.
  • Provide GMP/GDP expertise (interpretation and guidance) to internal and external customers, proactively maintaining cognizance of current GxP standards.
  • As subject matter expert, collaborate with other internal functions to identify, assess, and communicate quality related risks and trends and improvement opportunities and provide input for mitigation activities.
  • Actively support regulatory inspections (and preparations for), as requested.
  • Assist in developing periodic reports to senior management as requested
  • Assisting with training/orientation for new Quality staff

Job requirements

Who are you

  • Bachelor’s Degree or above with a minimum of 8 years of Quality Assurance/Compliance experience with at least 5 years of auditing experience is required
  • Experience with GDP, GMP is required. Pharmacovigilance and drug safety experience is also a benefit although not required
  • Able to navigate through a rapid changing environment.
  • Passion for embedding quality within the organisation.
  • Confident and adept in the use of computerized databases and other applications
  • Ability to interpret policies, standards, and regulations, and then evaluate potentially critical problems not covered
  • The position may requires approximately 30 % travel internationally.

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…!