Description

You will provide QA oversight for the AT production facility, ensuring GMP compliance and supporting vaccine and antibody development. Responsibilities include reviewing manufacturing activities, managing change controls, leading risk assessments, and acting as QA representative during inspections. This role offers the stability of a global CRO while working directly with a single sponsor.

Requirements

• Experience in quality and compliance for new products in clinical trials and early launch
• Knowledge of GMP, aseptic processing, Annex 1
• Experience in vaccine and antibody development, production and marketing
• Strong collaboration skills with internal teams and external partners
• Ability to work in a fast-growing global CRO environment

Responsibilities

• Provide quality oversight for AT production facility ensuring GMP compliance
• Support change control, documentation, training, and inspection readiness
• Review investigations, assess non-conformances, approve CAPAs and product dispositions
• Lead risk assessments and GMP training initiatives
• Act as QA representative during regulatory inspections and on-call support rotation