Head of Validation, Quality - Mechelen,BE/Romainville,FR/Leiden,NL

Job description

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 Head of Validation, Quality –Mechelen,BE/Romainville,FR/Leiden,NL

 

Your scope

This is an exciting and highly visible opportunity for a highly-experienced and ambitious professional to take on a newly created role with an innovative biotech organization at a time of critical growth where validation activities across different business areas are increasing.

 

You represent a critical hire for Galapagos; essential in securing the success of the future launches from a regulatory and compliance perspective. You will benefit from high visibility both internally and externally. Building trustworthy relationships with key internal and external stakeholders will be essential to your success. Fundamentally you will be accountable for providing continuous support to validation activities with cross all the GxP areas including Computer System Validation (CSV) support during the Galapagos System Development Life Cycle Activities but also help us

 

Key to your success will be to execute out of the box thinking in tackling potential quality issues and apply a critical eye on the situation as well as coming up with creative solutions.

 

You will be part of a highly-experienced community of professionals who enthusiastically support each other. At the same time, you will have the opportunity to work in an independent way where you will be trusted to drive priorities and deliver strongly to business needs.

 

Your responsibilities

 

  • Provide the necessary quality support during the “set-up, implementation, change control and decommissioning activities” of GxP systems, processes and equipment.
  • Provide quality oversight and review / approve computer systems 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 GLPG Validation subject matter expert supporting the Galapagos organization.
  • Contribute to the development and maintenance of the necessary procedural documents describing the computer system validation activities and ensure that the computer system related “change control mechanisms” are integrated in the GLPG Quality Management System.
  • Collaborate with the Quality Management team with regards to audit programs by independent auditors.  Assists the business stakeholders to ensure proper CAPA formulation.
  • Build a collaborative working relationship with the different department heads and cross-functional peers.  Lead the validation activities in the organization tailored to the specific business needs.

Requirements

Who are you

  • Master’s degree in a scientific discipline or equivalent of education and experience.
  • Approximately 10 years’ experience in areas of validation.
  • Strong knowledge of Development processes within GXPs and regulatory requirements.
  • Good understanding of Quality Management Systems.
  • Excellent understanding of the risk based approach.
  • Ability to present complex issues in a way that is understandable cross-functionally and at all levels of the organization.
  • Excellent decision making, problem solving and analytical skills, including knowledge of root cause analysis tools / methodologies.
  • Strong interpersonal skills resulting in an effective (intra and cross-departmental) team player.
  • Strong personality with a high degree of flexibility, assertiveness and excellent communication skills are essential to success.
  • Experience with inspections of validation activities.
  • Knowledge of the corporate structure, knowledge of the corporate culture and the organization of the external partners are essential. 

 

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…!