Head QMS/LMS - Mechelen,BE/Basel,CH

☞ Galapagos

View: 145

Update day: 26-11-2025

Location: Mechelen Antwerp

Category: Other

Industry: Biotechnology Research Pharmaceutical Manufacturing

Position: Director

Job type: Full-time

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Job content

Job DescriptionPleased 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 Head QMS/LMS - Mechelen,BE/Basel,CHScope of the jobYou will lead the drive to change human behaviors and culture to ensure QMS implementation across Galapagos’ sites. You take ownership of the QMS/LMS Compliance to ensure that regulatory and Galapagos’ requirements are met. Thinking steps ahead, identifying risks and opportunities, understanding the strategic and operational needs of the business, keeping up to date with regulations and managing vendor relationships, are among the challenges generating your enthusiasm for this opportunity.The role reports to the Head of Quality System & Standards & Digital Strategy.More In Detail, You Will
  • Develop end-to-end strategy for GLPG procedural document
  • Develop necessary definitions & enhance QMS hierarchy to supports risk-based principles in a QMS
  • Develop strategy for the further digitalization of the QMS (e.g., risk data)
  • Ensure that current and upcoming regulations, emerging industry trends and best practices are appropriately translated into QMS through procedures and training (e.g., ICH updates)
  • Act as key point of contact with business partners on the QMS topics – drive improvements in QMS approaches based on internal/external needs.
  • Engage with key stakeholders to analyze QMS trends, lessons learned and best practices.
  • Develop, analyze, monitor and improve new quality metrics based on the Quality Management System
  • Support the further integration of risk management principles in the overall QMS
  • Apply Business Process Management Principles in revamping the QMS (e.g., process-oriented thinking; continuous improvement approaches; and driving a Business Process Owner framework)
    • Build strong relationships with leaders across the organisation and assist in the continuous improvement and lifecycle management of GxP policies and quality management systems, including providing guidance and direction for transitioning from clinical to commercial operations;
    • Advocate for and exhibit the quality mind-set and behaviours, which will enable effective adherence to our standards;
    • Act as SPOC for the QMS processes during audits and inspections
    • Train / align with relevant stakeholders to ensure sustainability;
    • Benchmark within and outside of the Company, including regulatory agencies, business partners and suppliers
    • BPO lead of the Veeva platform
Who are you?
  • Master/Bachelor in Scientific related Studies with at least 10 years of relevant working experience
  • You are able to keep oversight whilst performing or supervising diverse activities for multiple projects, good planning and organizing skills describe you as a professional!
  • A diplomat and strong communicator, you reach goals by motivating and persuading others and as such you have impact on and you facilitate decision-making within the company
  • You have a profound knowledge and understanding of the relevant regulations and a strong interest in best demonstrated practices across the industry.
  • Your professionalism goes hand in hand with pragmatism when you ensure a sustainable implementation of regulations
  • You have business acumen and an excellent command of English
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…!
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Deadline: 10-01-2026

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