Quality Assurance Manager

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

Quality Assurance Manager

The Quality Assurance Manager is responsible for performing quality assurance activities as defined in the quality management system, ensuring compliance with applicable standards and regulations.

Summary

This role is an individual contributor position within a global quality organization and has no direct reports. The position requires effective collaboration with cross‑functional teams to support compliance and quality objectives.

Responsibilities

• 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 and inspector inquiries in collaboration with subject matter experts
• Coordinate the investigation, root cause analysis, CAPA development and timely resolution of audit findings.

Quality System Oversight & Documentation

• Review and approve controlled documents and records, to ensure accuracy, completeness and compliance with internal procedures and regulatory requirements
• Review and approve quality events, deviations, complaints, investigations and CAPAs.
• Facilitate, review and approve change control activities
• Support Quality Management System processes, quality processes training, internal audits, supplier qualification and oversight, computerized system validation, equipment lifecycle management, quality metrics, risk management and continuous improvement initiatives.

Education

• Bachelor's degree in a scientific discipline, or equivalent by experience

Main Requirements

• Minimum 3 years of Quality Assurance experience in a regulated environment, preferably within the biotechnology, pharmaceutical, CRO, medical laboratory or medical device industry, with exposure to GCP, GCLP, CAP/CLIA, ISO 15189, ISO 13485, and applicable regulatory requirements.
• Attention to detail
• Good knowledge, orally and written of English
• Good communication skills (verbal and written)
• Good analytical thinking skills
• Able to establish work priorities and meet deadlines
• Applies risk‑based thinking
• Professional and positive attitude, take initiative and act accountable

Working Conditions

• Full‑time position with a hybrid work schedule requiring a minimum of three days onsite per week.

About CellCarta

CellCartais a leading provider of specialized precision medicine laboratory services to the biopharmaceutical industry. Leveraging its integrated analytical platforms in immunology, histopathology, proteomics, and genomics, as well as related specimen collection and logistics services, CellCarta supports the entire drug development cycle, from discovery to late‑stage clinical trials. The Company operates globally with facilities located in Canada, USA, Belgium, Australia, and China.

Joining CellCarta means working with dedicated professionals who are focused on achieving our mission of impacting the future of patient therapy. We make a difference in the lives of patients around the world!

Join us as we make an impact on patient therapy!

The information collected to review your application will be processed by the human resources services of CellCarta Biosciences Inc. and its affiliates (collectively, "C