Quality System Specialist – Deviation Management

About the role

The Quality System Specialist – Deviation Management is the local expert responsible for coordinating deviations and CAPA processes at the PolyPeptide Braine site. The role ensures compliance with global and local regulatory requirements, drives continuous improvement, and supports capability building through coaching and performance management.

Key responsibilities

• Define and follow‑up the deviations & CAPA roadmap for the site, ensuring alignment with the Site Quality Plan and global requirements.
• Develop, maintain and monitor the Quality Management System for deviations & CAPA, reporting performance through KPIs and periodic reports to the Quality Council and PPL Group.
• Create, review, and deliver training material on deviations, CAPA, and root‑cause analysis tools; coach and mentor personnel from onboarding to advanced maturity.
• Lead an internal network of deviations & CAPA champions and act as the site point of contact within the PPL group’s multi‑site community of practice.
• Perform internal audits, support external audits and inspections as a subject‑matter expert, draft responses and manage follow‑up actions.
• Serve as the main contact for the Deviation Champion Program, improving investigation quality, reducing recurrence through effective CAPAs, and ensuring timely resolution.
• Backup the Quality System Change Control Specialist and follow external customer complaints and recalls.