Senior Quality Management Specialist - 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 & 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 Senior Quality Management Specialist - Mechelen, BE

Scope of the job

You will be responsible for the operational management of the Quality Management System (QMS) module hosting the quality procedural documents and quality records, as well as for the operational management of quality processes in the QMS system as deviations, change control and quality complaint management. You will also be responsible for the record retention and archiving management company wide.

Principal QMS Accountabilities:

  • Procedural Document maintenance (creation, stakeholder management for the workflow, format checking documents, metadata verification, participation in the Procedural Governance Board, periodic reviews, obsoletion of documents, launching of documents for approval)
  • First-line helpdesk function and incident management for the QMS system issues
  • Maintenance and initiation of the QMS FAQ site, guidances and quick wins
  • Creation of Procedural document metric reports
  • Liaison and close interaction with the training team to ensure the draft to effective workflow is complete
  • Key interaction with the QMS System owner for complex QMS issues to ensure on-time resolution
  • Creation and maintenance of QMS Manuals and Quick Reference Cards
  • QMS Change Management
  • Participate in the coaching and mentoring of the business to implement QMS processes such as CAPA, deviation, escalation etc.
  • Follow-up on outstanding and open deviations with business and help and coach where necessary to enable closure
  • Participate in the preparation of the Quality Management Review

Job requirements

Who are you?

  • Bachelor or Master Degree in any field
  • Accurate and precise with the ability to plan activities and organize own work to meet deadlines and strong organization skills
  • A strong personality, high degree of flexibility, assertiveness and excellent communication skills
  • System minded and has a good knowledge of current computer applications (Word, Excel, ...). In addition, well-developed problem solving, decision-making and analytical thinking skills
  • Providing support is frequent and require excellent interpersonal skills and diplomacy

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…!