QMS Process & Program Lead - Basel,CH or Mechelen,BE

Job description

Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company. We’re in the business of changing lives.

Galapagos’ mission is to make a lasting positive contribution to society through discovery of innovative therapies for diseases with large unmet medical need. Galapagos seeks to develop a robust portfolio of therapies that have the potential to revolutionize existing treatment paradigms. The company’s ambition is to become a leading global biopharmaceutical company, focused on the discovery, development and commercialization of innovative medicines to improve patients’ lives. Galapagos’ historic focus on developing first-in-class medicines based on the discovery of novel targets in inflammation and fibrosis has led to the successful launch of our first medicine in rheumatoid arthritis in 2020 and in ulcerative colitis in 2021. The pivotal study in Crohn’s Disease is fully recruited and we expect topline data and potential approval in this new indication in a couple of years.

Galapagos is now entering an exciting new chapter to expand and diversify its pipeline for the future, starting with oncology, specifically CAR-T cell-therapy, a transformative treatment of different types of cancer. Through the combined acquisitions of CellPoint and AboundBio, we are propelling ourselves into next-generation cell therapies. CellPoint brings a novel, decentralized point-of-care cell therapy manufacturing model, which has the potential to offer efficient, 7-day time to treatment and avoids complex logistics, resulting in potential better patient outcomes and broader access. AboundBio’s cutting-edge fully human antibody-based platform provides access to a research engine for next generation multi-targeting CAR-Ts that have the potential to deliver deeper and durable clinical responses and that will be developed using CellPoint’s decentralized model.

We are looking for a QMS Process & Program Lead - Basel,CH or Mechelen,BE

Scope of the job

You lead the effective development, implementation, maintenance and monitoring of assigned QMS processes. In addition, you are a key player as part of the Galapagos business strategy by facilitating and accelerating the quality integration of acquired companies specifically in the area of Cell Therapy. You strongly contribute to the Digital Transformation journey and the promotion of the quality mindset, being ahead thinking, enthusiastic and able to embrace changes. You report to the Head of QMS/LMS.

More in detail, you will:

  • Own and lead QMS processes (including the IT system aspect) such as :
    • Quality Management Review
    • Escalation management
    • Regulatory intelligence and assessment
    • QMS Knowledge Management
    • Quality Event & Issue Management
    • CAPA management
  • Act as BPO for owned QMS processes and collaborate with SPOCs, ITS and CSV
  • Act as key point of contact with business partners on the owned QMS processes – drive improvements in QMS approaches based on internal/external needs.
  • Engage with key stakeholders to analyze QMS processes trends, lessons learned and best practices.
  • Support the development, analysis, monitoring and improvement new quality metrics based on the Quality Management System
  • Act as SPOC for the QMS processes during audits and inspections
  • Benchmark within and outside of the Company, including regulatory agencies, business partners and suppliers
  • Support the further integration of risk management principles in the owned QMS
  • Lead QMS integration programs and support the quality integration of acquired business and companies
  • Support the development and the efficient implementation of quality integration framework and methodology
  • Support necessary definitions & enhance QMS hierarchy to supports risk-based principles in a QMS
  • Contribute to strategy development for the further digitalization of the QMS (e.g., risk data)

Job requirements

Who are you?

  • Master/Bachelor in Scientific related studies with at least 5-10 years of relevant working experience
  • You have a good understanding of ATMP regulations and processes, specifically in Cell Therapy is an asset
  • A 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 good knowledge and understanding of the relevant regulations and an 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…!