Quality Assurance Manager

Quality Assurance Manager

CellCarta

Wilrijk, Belgium

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

Client Audits & Regulatory Inspections

• 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.