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Test lead

Beerse
Infotree Global Solutions
Publiée le Publiée il y a 12 h
Description de l'offre

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)

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