QA / Validation Test Lead – Life Sciences / LIMS - Beerse - Infotree Global Solutions

    Infotree Global Solutions
    Infotree Global Solutions Beerse

    3 dagen geleden

    Beschrijving

    𝗟𝗮𝗯𝗩𝗮𝗻𝘁𝗮𝗴𝗲𝗟𝗜𝗠𝗦𝗤𝗔𝗧𝗲𝘀𝘁𝗟𝗲𝗮𝗱 (𝗖𝗦𝗩 / 𝗩𝗮𝗹𝗶𝗱𝗮𝘁𝗶𝗼𝗻 / 𝗣𝗵𝗮𝗿𝗺𝗮)

    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
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