Quality Management Lead GCP- 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 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 Quality Management Lead GCP - Mechelen, BE
Scope of the job
You are responsible for implementing the "pro-active quality principles" throughout the Clinical Development organization by providing continuous support and input during the Clinical Development Activities in the GCP area.
You are also involved in the management of GLPG GCP procedural documents (ProcDocs) i.e. in the creation, review, approval, distribution, revision and obsoletion of GLPG GCP ProcDocs.
- Build GCP compliance awareness throughout the Clinical Development organization:
- Build and maintain strong cross-functional collaborative working relationships. Assist in driving change to build a culture of quality compliance throughout the Clinical Development organization.
- Provide continuous quality compliance support by acting as an internal advisor on relevant processes, procedural documents and regulations to ensure correct interpretation and implementation.
- Mitigate quality compliance risks.
- Act as a point of contact for any quality related questions, concerns.
- Escalate quality / compliance / privacy issues and support investigation.
- Collaborate to audit and inspection activities:
- Collaborate with the Quality Assurance Lead giving input for the creation and maintenance of audit programs.
- Assist the business stakeholders to ensure proper CAPA formulation and timely CAPA implementation and follow-up.
- Conduct, reporting and follow-up of vendor QA qualification assessments.
- Lead / contribute to Regulatory Authority Inspections.
- Identify areas for improvement based on Quality Management activities and audit / inspection outcome.
- Support effective implementation of the QMS-ProcDocs in the GCP organization:
- Develop procedural documents in line with GxP and with the GLPG Quality Manual, in collaboration with the business stakeholders. Contribute to the creation of new procedural documents, as well as to the revision of procedural documents.
- Conduct procedural documents review and approval activities.
- Follow-up on procedural documents distribution and training activities.
- Follow-up on procedural documents lifecycle.
- Participate in and collaborate to continuous improvement initiatives.
- Support in training activities i.e. process training, new regulations training, new systems training, etc.
Who are you?
- Bachelor or Master Degree in any field
- Accurate and precise with the ability to plan activities and organize own work to meet deadlines and strong organization skills
- A strong personality, high degree of flexibility, assertiveness and excellent communication skills.
- Require excellent interpersonal skills and diplomacy
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…!