QA Manager

Strandassociates; Corbais; Hybride; EUR 90 000 - 130 000; Plein temps

Avantages offerts par ce poste

Attractive salary

Very competitive extra-legal benefits

Homeworking possibilities

Training and workshops

Résumé du poste

Strandassociates invites a senior QA professional to lead eQMS administration and document control within Scilife, ensuring GCP compliance across clinical trials. You will drive deviations, CAPA, and audit readiness while supporting IT validation activities in a high-growth biotech setting.

The role requires extensive GCP experience, strong English communication, and autonomous work in a fast-paced environment. Based in Belgium with options for homeworking and hybrid work arrangements.

Qualifications

• Minimum 10 years of hands-on QA experience in GCP within pharma/biotech/CRO.
• Proven expertise in Scilife administration (workflow, training, reporting).
• Strong experience in managing GCP quality systems, deviations, CAPA, and inspection readiness.
• Fluency in professional English.

Responsabilités

• Lead eQMS administration and document control in Scilife.
• Oversee training administration, user support, reviews, lifecycle, reporting.
• Manage obsolete documents and ensure system maintenance.
• Provide QA guidance to ensure GCP compliance across clinical ops.
• Support deviations, CAPA, root cause analysis and investigations.
• Assist IT validation / CSV activities.

Connaissances

QMS & GCP regulations

Scilife administration

Deviations & CAPA

Internal auditing

IT validation / CSV

Outils

Scilife

Description du poste

Our client is a Belgian clinical-stage biotechnology company developing groundbreaking, highly innovative therapies in advanced therapeutics. Based in Walloon Brabant, the company combines a strong scientific foundation with a fast-scaling, dynamic, and collaborative environment.

With several clinical programs actively advancing, maintaining a high-standard Quality Management System (QMS) and strict adherence to GCP regulatory frameworks are critical to supporting their upcoming clinical milestones and regulatory submissions.

Why this role is key for the business:

Full ownership: You will serve as the internal reference and administrator for the company’s eQMS platform (Scilife), managing document control workflows and training management end-to-end.

Cross-functional impact: You will work directly alongside Clinical Operations and Quality leadership to drive GCP compliance, deviation management, and audit readiness across ongoing clinical trials.

• Key transition phase: As the company scales its clinical portfolio, your role will be instrumental in ensuring seamless compliance and IT system alignment (CSV) in a fast-paced, high-standard biotech environment

Key Responsibilities

1. eQMS Administration & Document Control (Scilife)

Lead the administration and maintenance of quality documents within the Scilife platform.

Oversee training administration, user support/helpdesk activities, periodic reviews, document lifecycle, exports, and archival activities.

Manage obsolete documents and ensure system maintenance and reporting accuracy.

2. Clinical Quality Assurance & GCP Oversight

Provide expert QA guidance and support to Clinical Operations teams to ensure strict GCP and internal quality compliance.

Review and support quality documentation related to clinical operations activities and internal audits.

3. Deviations, CAPA & Continuous Improvement

Manage and coordinate deviations related to clinical operations and audit activities.

Drive investigation support, root cause analysis, CAPA follow-up, and effectiveness verification.

Participate in continuous improvement initiatives and support inspection and audit readiness activities.

4. IT Validation / CSV (approx. 10% of workload)

• Support IT validation activities, including documentation review, compliance oversight, and validation support.

Core Competencies & Key Skills

Deep expertise in Quality Management Systems (QMS) & GCP Regulations.

Scilife Administration & Document Control.

Deviation and CAPA Management & Internal Auditing.

Knowledge of IT Validation (Computer System Validation - CSV) is a strong plus.

Excellent written and verbal communication skills.

Computer System Validation (CSV / IT Validation) is a strong plus.

Excellent communication skills and ability to work autonomously in a high-growth biotech setup.

Criteria

Minimum 10 years of hands-on Quality Assurance experience in Good Clinical Practice (GCP) within a pharmaceutical, biotechnology, or CRO environment.

Proven expert-level expertise in Scilife administration and management (including workflow administration, document lifecycle, training management, and reporting).

Strong experience in managing GCP quality systems, leading deviations, root cause analysis, CAPA follow-up, and inspection readiness.

Fluency in professional written and spoken English.

Offer

• Attractive salaryin line with the market and your experience;
• Salary package with very competitiveextra-legal benefits;
• Optimum work-life balancethanks to 12 ADV days, sliding hours and homeworking possibilities;
• Join a community of over 200consultants in quality and regulatory affairs, with many social events organized throughout the year;
• Training and workshops to develop/share your skills.