QA Lead, Cell Therapy & GMP Compliance

Cellistic; Mont-Saint-Guibert; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

Cellistic, based in Mont-Saint-Guibert, Belgium, seeks a QA Lead to partner with Manufacturing and Development teams, providing quality leadership from transfer and process development through GMP production of iPSC-derived therapies.

You will drive GMP documentation oversight, Change Controls, Deviations and CAPAs, and ensure alignment with EU GMP requirements and regulatory expectations on the shop floor.

Qualifications

• 5+ years QA experience in biopharma/ATMPs or GMP environments.

Responsabilités

• Quality oversight of iPSC cell culture, cell banking, bioreactor and aseptic manufacturing activities.

Connaissances

QA experience

GMP

Change Control

Deviations

CAPAs

Quality Risk Management

Technology Transfer

Process Validation

Aseptic Manufacturing

Cell Therapy

EU GMP knowledge

English Proficiency

Formation

Master’s or PhD in Life Sciences or related

Description du poste

Cellistic, based in Mont-Saint-Guibert, Belgium, seeks a QA Lead to partner with Manufacturing and Development teams, providing quality leadership from transfer and process development through GMP production of iPSC-derived therapies.

You will drive GMP documentation oversight, Change Controls, Deviations and CAPAs, and ensure alignment with EU GMP requirements and regulatory expectations on the shop floor.