Test Lead - Beerse - Infotree Global Solutions

    Infotree Global Solutions
    Infotree Global Solutions Beerse

    15 uur geleden

    60.000 € - 90.000 € (EUR) per jaar *
    Beschrijving

    Position: Test Lead – LabVantage LIMS (Quality Governance & Validation Lead)

    Location: Beerse, Belgium

    Duration: 1 year (long-term)

    Mode of Hire: Independent Contract (Hybrid)

    Equipment Provided: Laptop

    Salary: Open – competitive, based on experience and market rates

    Role Summary:

    The LabVantage On-Site Test Lead will provide strategic quality leadership for LabVantage 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. LabVantage LIMS Testing & Validation

    Lead testing across LabVantage modules:

    • 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.
    • 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.

    Required Experience

    Mandatory

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

    Technical Expertise

    • LIMS workflows.
    • SQL/Data validation.
    • Instrument integrations.
    • API testing.
    • Test management tools (JIRA/x-ray)
    * Dit salarispakket is een schatting gemaakt door beBee
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