Quality Assurance consultant - Contractor

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

We are in the business of changing lives. Focusing on high unmet medical needs, we synergize compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class small molecules, CAR-T therapies and biologics in oncology and immunology. With capabilities from lab to patient, including a decentralized, point-of-care CAR-T manufacturing network, we are committed to challenging the status quo and delivering results for our patients, employees and shareholders.

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 Quality Assurance consultant

Core Purpose of Job:

Maintain oversight and control of incoming goods, materials, sample management, and equipment in collaboration with the Cell Tech Operation teams (e.g.,manufacturing and QC team).

Principal Accountabilities:

• Maintain oversight and control of equipment status at Galapagos sites as well as at the point-of-care manufacturing partners’ sites.
• Work in collaboration with QC teams to ensure oversight of equipment lifecycle including equipment qualification, maintenance and digital system deployment/updates.
• Material quality oversight including supply chain management, material qualifications, material specifications and incoming goods disposition.
• Reviewing and approving QMS records (deviations, change controls, CAPAs).
• Reviewing and approving QMS documents throughout the lifecycle and new process deployment.
• Quality assurance point of contact for systems implementations for QC Cell Tech Operation.
• Reviewing and approving QMS QC methods and method transfer documents.

Working Relationships:

• Quality Control (QC technician, QC analyst and QC managers of operations).
• Quality Assurance (QA Point-of-Care, QP)
• Manufacturing (Packaging of starting materials)
• Supply chain (incoming goods, materials qualification, vendor qualification)