Skills

Leadership Go Jira SQL Test Quality Assurance Test Automation Prioritization Risk Assessment Risk Mitigation Regression api testing Analytics

Job Specifications

( / / )

Location: Beerse, Belgium

Work Mode: Hybrid

Salary budget: Open for market rate

Employment Type: 1-year contract, renewable (long-term project)

Laptop Provided by Infotree

Role Summary

We are looking for an experienced QA / Validation Test Lead to provide strategic quality leadership for laboratory information systems (LIMS) implementations, upgrades, and sustainment programs within regulated Life Sciences environments.

The role will drive independent quality governance, validation excellence, risk mitigation, and multi-vendor coordination to ensure compliant and high-quality system releases aligned with global regulatory standards.

Key Responsibilities

1. Strategic Quality Leadership

Define enterprise-level testing and validation strategy aligned with program objectives.
Establish independent quality governance across vendors and workstreams.
Provide Go/No-Go release recommendations based on risk assessment.
Drive shift-left and risk-based testing approaches.

2. LIMS Testing & Validation

Lead testing across laboratory system modules, including:

Sample lifecycle management
Stability management
Instrument interfaces
Lab workflows and configuration validation
Data migration validation
Reporting and analytics verification

Ensure end-to-end validation traceability.

3. Computer System Validation (CSV) & Regulatory Compliance

Ensure compliance with:

GxP standards
FDA 21 CFR Part 11
EU Annex 11
ALCOA+ Data Integrity

Review and approve:

Validation Master Plan (VMP)
User Requirement Specifications (URS)
IQ/OQ/PQ protocols
Risk Assessments
Traceability Matrix

Support internal and external regulatory audits.

4. Stakeholder & Executive Engagement

Act as primary onsite QA representative for business and leadership stakeholders.
Engage with laboratory SMEs, Quality Assurance teams, regulatory compliance teams, and multi-vendor delivery partners.
Deliver executive-level reporting and risk communications.

5. Multi-Vendor Governance

Coordinate testing across multiple vendors.
Conduct defect triage governance forums.
Drive accountability and delivery alignment.
Manage escalations proactively.

6. Automation & AI Quality Transformation (Preferred)

Promote test automation adoption.
Introduce AI-based defect prediction or log analysis.
Optimize regression cycles using intelligent testing.

(Especially valuable for modernization or cost optimization programs.)

7. Defect, Risk & Release Management

Lead defect governance and prioritization.
Monitor defect leakage and quality KPIs.
Support release readiness and production cutover.

8. Reporting & Metrics

Provide executive dashboards covering:

Defect Density
First Pass Yield
Risk Heatmaps
Compliance readiness
Test coverage

Mandatory Skills

Experience:

12+ years QA/Test experience
4+ years LIMS experience
Pharma / Life Sciences domain exposure

Technical Expertise:

LIMS workflows
SQL / Data validation
Instrument integrations
API testing
Test management tools (JIRA / X-ray)

Nice to Have Skills

Test automation adoption
AI-based defect prediction or log analysis
Intelligent regression cycle optimization

(Especially valuable for modernization or cost optimization programs.)

Why Join

Drive strategic quality leadership for laboratory systems in regulated Life Sciences environments
Lead independent quality governance, risk mitigation, and validation excellence
Act as primary onsite QA representative for business and leadership stakeholders
Deliver executive-level reporting and compliance metrics
Long-term project with hybrid work mode
Urgently hiring

About the Company

Infotree Global was founded in 2002 in a small office in Canton, MI, Infotree Global had a clear mission; To bring the world’s best talent together with the greatest companies producing results through continuous improvement and innovation. From those humble beginnings, Infotree Global has explosively grown from a two-person operation to a global solutions company, functioning in over 150 countries across 5 different continents. Infotree Global proudly serves more than 250 of the Global 1000, numerous government agencies... Know more