Quality Assurance Manager: Regulatory Audits & QMS

CellCarta; Antwerpen; Hybride; EUR 70 000 - 100 000; Plein temps

Avantages offerts par ce poste

Hybrid work schedule

Résumé du poste

CellCarta, located in Antwerp, seeks a Quality Assurance Manager to ensure compliance with QMS across global operations. You will lead client audits, coordinate regulatory inspections, and drive CAPA investigations within cross-functional teams.

The role emphasizes QMS documentation, change control, and continuous improvement. Requires a bachelor’s degree in science and at least 3 years in a regulated QA environment, with a hybrid work arrangement (minimum three onsite days per week).

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.
• Excellent written and spoken English.
• Attention to detail and strong communication skills.

Responsabilités

• Lead client audits and regulatory inspections, including preparation, hosting, coordination, response management and follow-up activities.
• Present and explain the Quality Management System (QMS) and key operational processes.
• Coordinate and provide responses to auditor inquiries with subject matter experts.
• Coordinate investigations, root cause analysis, CAPA development and timely resolution of audit findings.
• Review and approve controlled documents and records to ensure accuracy and compliance.

Connaissances

Attention to detail

Good communication skills

Strong analytical thinking

English proficiency

Risk-based thinking

Ability to set priorities

Formation

Bachelor’s degree in a scientific discipline

Description du poste

CellCarta, located in Antwerp, seeks a Quality Assurance Manager to ensure compliance with QMS across global operations. You will lead client audits, coordinate regulatory inspections, and drive CAPA investigations within cross-functional teams.

The role emphasizes QMS documentation, change control, and continuous improvement. Requires a bachelor’s degree in science and at least 3 years in a regulated QA environment, with a hybrid work arrangement (minimum three onsite days per week).