QA Specialist – ATMP (first GMP licence)

About the role

A cell therapy company on the Tech Lane Ghent Science Park is moving its manufacturing from a hospital GMP unit into its own facility and applying for a FAMHP manufacturing licence in 2027. You are the second QA hire, building the PQS with the Head of Quality: document control, training, deviations, change control, supplier qualification.

Your responsibilities

• Write and implement PQS procedures for a Part IV ATMP facility
• Set up deviation, CAPA and change control systems in an eQMS
• Qualify critical suppliers (apheresis, media, single-use)
• Prepare the licence application and pre-inspection with the FAMHP
• Support facility qualification QA review

What you bring

Must-haves

• 4+ years QA in GMP manufacturing, ideally biologics or ATMP
• Experience building or overhauling a quality system
• EU GMP Part IV knowledge
• Fluent English; Dutch is a plus

Nice-to-haves

• eQMS implementation (Veeva, MasterControl)
• Hospital exemption or IMP background
• Belgian regulatory (FAMHP) exposure

What's offered

• €62,000–75,000 gross per year (Belgian package: car, meal vouchers, group insurance, 13th month)
• Equity participation plan
• Cross-border support for candidates relocating from the Netherlands

About the company

A VIB spin-out with 60 staff, Series B funded, preparing a first-in-human cell therapy for European trials.