Quality Management Lead – Commercial 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 and Paris), the Netherlands (Leiden), Switzerland (Basel), Italy (Milano), Spain (Madrid), the UK (London), Germany (München), and in the 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 – Commercial Quality, Mechelen,BE

Scope of the job

You are responsible for the operational management of the quality processes related to the commercial GMP and GDP activities. Your role is essential in securing the success of our future launches from a quality, regulatory and compliance perspective. You are working closely with internal partners (Quality Management, Manufacturing, Supply Chain, Regulatory, Affiliates etc) and external partners (Contract Manufacturing Organizations, 3rd Party Logistics Providers).

The primary accountabilities in this role are:

  • Assist in the development and maintenance of the Quality Management system for commercial GMP and GDP activities.
  • Support the QP/RP for routine activities and quality processes like batch record review, deviations, Change Controls, etc
  • Ensure routine CMO and 3PL quality oversight, maintain the related Quality Agreements.
  • Support Management Review, Product Quality Review, handling of Product Quality Complaints and recalls, Continued Process Verification.
  • Support the follow-up of internal/external Audit, Regulatory Inspections.
  • Provides continuous GMP/GDP compliance support by acting as an internal Quality advisor on the key quality systems and procedures to ensure correct interpretation and implementation
  • Builds collaborative working relationships with cross-functional peers and advocates a Quality culture and mindset
  • Participate as appointed in projects related to commercial GMP and GDP activities.

Job requirements

Who are you?

  • Master degree in a scientific discipline or equivalent education
  • Minimum 5 years of experience in Pharmaceutical Industry (preferably QA) with proven knowledge and experience in GMP/GDP & regulatory requirements. Practical GMP/GDP experience is a distinct advantage.
  • Good understanding of the end-to-end pharmaceutical and supply chain lifecycle
  • Well-developed problem solving, decision-making and analytical thinking skills
  • Good interpersonal skills resulting in an effective (intra- and cross departmental) team player.
  • Auditing and Regulatory Authority inspection experience is considered an added value.
  • Eligible in Belgium to act as a QP/RP is considered an added value.

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…!