Quality Assurance Manager - Regulated Audits & QMS

Caprion Biosciences Inc.; Antwerpen; Hybride; EUR 70 000 - 100 000; Plein temps

Résumé du poste

CellCarta is seeking a Quality Assurance Manager to ensure compliance with quality standards and regulations across its global quality organization. The role is an individual contributor focused on audits, CAPA, change control and QMS oversight, with collaboration across cross-functional teams.

The candidate will review documents, support internal audits and supplier qualification, and drive continuous improvement initiatives while maintaining strong English communication and analytical skills.

Qualifications

• Minimum 3 years of Quality Assurance experience in a regulated environment.
• Experience with GCP, GCLP, CAP/CLIA, ISO 15189, ISO 13485 and applicable regulatory requirements.
• Strong written and oral English skills.

Responsabilités

• Lead client audits and regulatory inspections, including preparation and follow-up.
• Present and explain the Quality Management System (QMS) and key processes
• Coordinate responses to auditor inquiries with subject matter experts
• Coordinate investigations, root cause analysis, CAPA development and timely closure
• Review and approve controlled documents and records for compliance
• Support QMS processes, internal audits, supplier qualification and oversight
• Facilitate change controls and risk management initiatives

Connaissances

Attention to detail

Good communication skills

Analytical thinking

Risk-based thinking

Prioritization & deadline management

Collaboration with cross-functional

Professional and positive attitude

Formation

Bachelor's degree in a scientific discipline

Description du poste

CellCarta is seeking a Quality Assurance Manager to ensure compliance with quality standards and regulations across its global quality organization. The role is an individual contributor focused on audits, CAPA, change control and QMS oversight, with collaboration across cross-functional teams.

The candidate will review documents, support internal audits and supplier qualification, and drive continuous improvement initiatives while maintaining strong English communication and analytical skills.