NPI (New Product Introduction) Quality Lead - Mechelen,BE
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’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: The ‘make-it-happeners’.
We are looking for a New Product Introduction (NPI) Quality Lead -Mechelen,BE
Scope of the job
Galapagos will be introducing new, self-developed medicinal products to the market. The quality department has a key role to ensure the compliant and reliable setup of our New Products. In this role you will be partnering closely with the New Product Introduction, CMC group as well as with our partner Gilead and be the voice of Quality of Galapagos in all different aspects of introducing a new product.
- Set up the required quality management in NPI, to embed quality competencies, quality processes and most importantly quality data and information across NPI and operations/CMO’s and other stakeholders.
- Acting as the quality lead in:
- New product Introduction project teams
- Lifecycle management of our products, processes and related materials
- Own the development of comprehensive risk documentation for the products and processes including risk management reports and plans
- Provide support and mentorship to teams in design control, process validation and identification of product and process CTQs, CPP’s, CQA’s
- Review and approve design verification/validation, method validation and process validation protocols and reports of drug substance and drug products
- Perform oversight on statistical data analysis, sampling plans, batch size definition, specification settings
- Ensure test methods used to verify product design or manufacture of products/components are appropriate and are accurately validated.
- Support definition & roll out of stability studies
- Provide Quality support to external (primary and/or secondary) material suppliers and/or finished goods manufacturers.
- Lead and/or support thorough investigations and quality issues (CAPAs, non-conformances, OOS, audit observations & etc.) while ensuring effective corrective and/or preventive actions.
Who are you?
You are a Quality Professional with five years of proven experience in this field, more specifically:
- Experience in Biotech, Biopharmaceutical or Pharmaceutical, specifically in New Product Introduction Environment;
- Experience in how to set up and maintain collaboration with external partners and vendors;
- Should have intermediate to advanced knowledge in Risk Assessment, Test methodologies and Process Validation;
- Proven ability to handle/lead Quality work within projects having more than one task is required.
- Demonstrated ability to problem solve and collaborate effectively in project team setting.
- Ability to provide mentorship and direction to teams to ensure compliance to regulatory (e.g., cGMP, QSR, EU Directives, ISO standards, etc.) and company procedures is required.
- Experience collaborating and communicating quality requirements to external suppliers is strongly preferred.
- Ability to effectively prepare and/or evaluate documentation is required.
- Ambition to innovate and eager to propose new ways of working
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…!