QA Program Lead PoC

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’.

For our Cell & Gene Therapy organization in Leiden / NL, we are seeking a highly motivated QA Program Lead PoC (Associate Director) .

Scope of the job

You will support our QA point-of-care operations team in setting up, promoting and maintaining the QA model in our dynamic business environment. Our QA team is a team of 11 and plays a crucial role in building our QA model for our expanding organization while working closely together with the Point-of-Care manufacturing partners.

At Galapagos, we strongly believe in the power of collaboration to achieve our ambitious goals. This is reflected in how we divide tasks and support each other. Our workflow is dynamic, fast and varied.

As our QA Program Lead PoC, you will report to the QA Manufacturing Operations Lead, in the IMP QA Oncology team based in our Central EU site in Leiden, NL.

Your role

• Materials management :  Together with our business partners, you will be responsible for setting up and managing initial material qualification, specification review, recalls, change management. You will also act as the QA partner for the materials kitting process.
• Vendor management :  You will be responsible to oversee the risk-based vendor management activities for materials and equipment vendors. This entails maintaining a constructive relationship with critical suppliers, as well as risk assessing, supporting audits and QAA management for all vendors.
• Equipment management (excluding QC equipment) :  Manage qualification support and release relevant equipment for production. Building and maintaining a relationship with critical equipment suppliers.
• Being a team member of the point-of-care operations team, you will be taking an active role in Point-of-care manufacturing operations QA support. This entails supporting the front-line-support team in continuous batch support, as well as driving and manage batch related cross functional meetings to support timely batch release.