Quality Management Lead Clinical Development Cell Therapy - GCP focused

Pleased to meet you, we are Galapagos, a dynamic growing Biotech company with offices across Europe and in the US, headquartered in Mechelen, Belgium.

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 pioneer for patients. 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-happener’.

We are looking for a Quality Management Lead  Clinical Development Cell Therapy - GCP focused

Scope of the job

The QML Clinical Development Cell Therapy (CT) is the point of contact for the CT Research & Development (R&D) teams for all quality topics, with focus on the GCP, GLP and research activities.

The CT QM Clinical Development team owns the Quality Oversight on the CT R&D activities driven by the research, pre-clinical and clinical departments: Documentation, Input to Audits, Vendor oversight & management, Quality Events, Training, and drives quality processes such as deviations, change control and risk management.

Beyond that, the QML Clinical Development CT is involved in implementing the "Quality by Design” principles throughout the GLPG CT R&D organisation by providing continuous quality support and input during the operational activities.

Your role

• Quality point of contact (POC) for CT R&D teams, Central Quality Teams and in the appropriate governance bodies
• Build GxP compliance awareness throughout the CT R&D organization:
  • Build and maintain strong cross-functional collaborative working relationships. Assist in driving change to build a culture of quality compliance throughout the CT R&D 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
  • Ensure operational support and quality oversight for quality processes as e.g. CAPA, audits, inspections, deviation management, risk management, change control, quality complaint handling, etc.
  • Identify, manage and mitigate quality compliance risks, in collaboration with the operational and central QM teams
  • Act as a point of contact for any quality related questions, concerns
  • Escalate quality / compliance / privacy issues and support investigation
  • Drive Quality Management Review (QMR) Level 1 meetings

• Ensure through intense collaboration with the Quality Management System (QMS) team that the QMS is fit for the specific business, tailored where possible and standardized where needed:
  • Act as quality ambassador and advocate for QM process changes and implementation
  • Contribute to the creation of new procedural documents, as well as to the revision of procedural documents
  • Conduct procedural documents review and approval activities
  • Identify the impacts of changing regulations across the GxP areas
• Participate in and collaborate on continuous improvement initiatives.
• Support in training activities i.e. process training, new regulations training, new systems training
• Enable compliance and implementation of the quality processes
• Collaborate to audit and inspection activities:
  • Collaborate with the audit team 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
  • Contribute to Regulatory Authority Inspections
  • Identify areas for improvement based on Quality Management activities and audit / inspection outcome
• Adherence to existing Policies and Procedures and ensure timely completion of relevant training

This role can be based in Mechelen/BE, Basel/CH or Leiden/NL. Frequent presence in Leiden and occasional travel to external partners is required.

• Master's degree in a scientific discipline or equivalent by education and experience
• More than 10 years experience in the Pharmaceutical or Biotechnology industry with in-depth GCP knowledge and a minimum of 5 years in a Quality Management environment
• ATMP experience is a plus
• Current and strong knowledge of Clinical Development processes according to Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), other GxP guidelines and regulatory requirements
• The ability to present complex issues in a way that is understandable cross-functionally and at all levels of the organization
• Excellent problem solving, and analytical skills, including knowledge of root cause analysis tools / methodologies
• Strong interpersonal skills, an effective (intra- and cross-departmental) team player
• Excellent communication skills with a high degree of flexibility, diplomacy and assertiveness contribute to your success
• Proficiency in English is required
  

What’s in it for you?

You will be part of a fast growing and amazing company. As a ‘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 organisational skills. Our employees are the strength behind Galapagos, you will join a highly motivated team, eager to maintain our leading position and to achieve breakthroughs in pharmaceutical research. New team members have the opportunity to actively shape their position and contribute to our mission. Galapagos offers a competitive remuneration package and a dynamic work environment. Flexible working hours can be discussed.

We are Galapagos : together we can make it happen…!