Senior GxP Quality & Validation Expert
Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company with offices in Europe in Belgium (Mechelen), France (Romainville), the Netherlands (Leiden), Basel (Switzerland) and in Boston (US).
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 GxP Quality & Validation Expert – Mechelen,BE
Scope of the role
At Galapagos, the Senior GxP Quality & Validation Expert will be responsible for defining validation requirements across the R&D organization. Starting initially in Development with computer systems validation (CSV), you will later on give direction in validation activities linked to manufacturing, e.g., equipment qualification, process validation, cleaning validation, and assist Research and other functional areas in defining validation/test strategies.
Validation practices should be in line with industry best practices, however by using pragmatic approaches, and should ensure alignment with the current state of Regulatory Authorities’ expectations.
You will be a validation subject matter expert, lead and manage the Galapagos validation program, examine validation processes and recommend improvements including developing, documenting, and implementing procedures and validation deliverables. You will work closely with the departments including quality. (S)He will define, support and guide validation activities both internally and at external service providers.
- Provide the necessary quality support during the “set-up, implementation, change control and decommissioning activities” of the Galapagos validation activities.
- Provide quality oversight and write / update or review / approve validation deliverables as required, including validation plans, requirement specification documents, validation protocols, test scripts, IQ/OQ/PQ validation reports and associated change control to ensure regulatory requirements are met.
- Act as the Galapagos' Validation subject matter expert supporting the Galapagos organization.
- Contribute to the development and maintenance of the necessary procedural documents describing the validation activities and ensure that “change control mechanisms” are integrated in the Quality Management System.
- Collaborate with the R&D Quality Department with regards to audit programs by independent auditors. Assists the business stakeholders to ensure proper CAPA formulation.
- Build a collaborative working relationship with the IT/IS department and cross-functional peers. Assists in driving change to build a culture of compliance throughout the organization.
- Acting as a subject matter expert to support internal and external stakeholders.
Important to know
- Unique opportunity to join a fast-growing, entrepreneurial Biotech firm dedicated to the development of innovative treatment.
- Since this is a newly created role you will have the chance to shape it to ensure it meets the business needs.
- Creativity and out of the box thinking are encouraged at Galapagos so you will be working in an open culture that promotes innovation.
- This role is a key priority for the organization. You will have the opportunity to hold a broad mandate combining operational and strategic responsibilities where your input will be valued and have a key impact on meeting validation needs.
- This is an opportunity to join Galapagos at a key time of their development and be part of an exciting journey with a cutting-edge organization dedicated to finding first-in-class treatments.
Who are you?
- You have a degree related to or working experience with computer system development and / or computer system validation;
- You have at least a few years of experience within the (pharmaceutical) industry
- You have expert knowledge of legislation and regulations related to computer system validation
- You have experience with setting up projects and leading them within the deadlines
- You have strong communication, both written and verbal in 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…!