QA Manager

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 a leading consulting group specialized in Life Sciences, bringing together more than 3,200 consultants and experts and supporting over 1,000 clients worldwide, including 90% of the leading pharmaceutical, biotech and medtech companies.

In Belgium, our teams contribute to high-impact projects for major Life Sciences players, addressing key challenges across Quality Assurance, Regulatory Compliance, Clinical Operations and Validation.

As part of our continued growth in Belgium, we are looking for an experienced QA Manager with strong expertise in Good Clinical Practice (GCP) and Scilife eQMS administration to support one of our biotechnology clients in maintaining and strengthening its Quality Management System.

Your role

As a QA Manager, you will play a key role in ensuring GCP compliance, managing quality systems and supporting Clinical Operations within a highly regulated biotechnology environment.

Your main responsibilities will include:

• Managing and maintaining the Scilife eQMS platform, including document control, training management, workflows, periodic reviews and archival activities;
• Providing Scilife administration and user support, ensuring effective system utilization and compliance;
• Reviewing and maintaining quality documentation related to Clinical Operations and internal audits;
• Managing deviations, investigations, root cause analyses and CAPAs, including effectiveness checks;
• Providing Quality Assurance guidance to Clinical Operations to ensure compliance with GCP requirements;
• Supporting internal audits, inspection readiness and continuous improvement initiatives;
• Contributing to Computer System Validation (CSV) activities, including validation documentation review and compliance oversight.

Your profile

We are looking for a highly experienced Quality Assurance professional with proven expertise in GCP environments and advanced Scilife administration skills.

Mandatory requirements:

• Minimum 10 years of hands-on experience in GCP Quality Assurance within the pharmaceutical, biotechnology or clinical research industry;
• Advanced expertise in Scilife eQMS, including system administration, document management, training management, workflow configuration and reporting;
• Strong experience in QMS management, deviations, CAPAs, internal audits and inspection readiness;
• In-depth understanding of GCP regulations and quality compliance requirements;
• Excellent written and verbal English communication skills;
• Strong organizational skills, autonomy, attention to detail and ability to collaborate with multidisciplinary teams.

Nice to have:

• Experience in Computer System Validation (CSV) and IT validation activities;
• Previous experience supporting Clinical Operations within a biotechnology environment.

Please note: Proven expertise in both GCP Quality Assurance (10+ years) and Scilife eQMS administration is essential for this position.

What makes Efor different?

• A strong community of consultants and experts to share knowledge, discuss technical challenges and leverage field experience;
• A Knowledge Management environment designed to develop, structure and share expertise across the Group;
• Digital & AI tools supporting our consultants in tackling complex challenges more efficiently;
• A career path tailored to your ambitions, whether you want to deepen your technical expertise or progress towards leadership, project management or subject matter expertise;
• A wide variety of projects and technical environments with leading pharmaceutical and biotechnology companies.

Our ambition goes beyond placing you on a project: we want to give you the environment, expertise and opportunities to grow and build your career over the long term.

Ready for your next challenge?

Are you an experienced GCP Quality Assurance professional with advanced Scilife eQMS expertise, looking to contribute to impactful projects within the biotechnology industry?

Join Efor and let's build the next step of your career together.