Senior GCP QA Manager • Scilife eQMS Expert for Biotech

EFOR (formerly CVO-Europe); Mont-Saint-Guibert; On-site; EUR 90,000 - 130,000; Full time

Job summary

EFOR is seeking a seasoned QA Manager with deep GCP expertise to support a biotechnology client in Belgium. You will be responsible for maintaining and strengthening the Quality Management System and ensuring regulatory compliance across Clinical Operations.

You will manage Scilife eQMS administration, oversee deviations, CAPAs, internal audits, and CSV activities, collaborating with multidisciplinary teams to drive inspection readiness and continuous improvement.

Qualifications

• Minimum 10 years hands-on GCP QA experience in pharma/biotech or clinical research.
• Advanced Scilife eQMS administration including document management and workflows.
• Strong experience in QMS management, deviations, CAPAs, internal audits and inspection readiness.
• In-depth knowledge of GCP regulations and quality compliance requirements.
• Excellent written and verbal English communication skills.
• Strong organizational skills and ability to collaborate with multi-disciplinary teams.

Responsibilities

• Manage Scilife eQMS platform: document control, training management, workflows, reviews and archival.
• Provide Scilife administration and user support for compliance.
• Review and maintain quality documentation for Clinical Operations and internal audits.
• Manage deviations, investigations, root cause analyses and CAPAs with effectiveness checks.
• Provide QA guidance to Clinical Operations to ensure GCP compliance.
• Support internal audits, inspection readiness and continuous improvement initiatives.
• Contribute to CSV activities including validation documentation review and oversight.

Skills

GCP QA

Scilife eQMS

Document control

CAPA management

Internal audits

CSV validation

IT validation

Clinical Ops support

English fluency

Tools

Scilife eQMS

Job description

EFOR is seeking a seasoned QA Manager with deep GCP expertise to support a biotechnology client in Belgium. You will be responsible for maintaining and strengthening the Quality Management System and ensuring regulatory compliance across Clinical Operations.

You will manage Scilife eQMS administration, oversee deviations, CAPAs, internal audits, and CSV activities, collaborating with multidisciplinary teams to drive inspection readiness and continuous improvement.