QI
Test Lead - GxP Software Quality (Data Review & Data Management Platform)
Accepting applicationsQuantum Integrators · Hyderabad, Telangana, India
Full-Time Mid_senior aiaterf
Posted
5d ago
Category
Test
Experience
Mid_senior
Country
India
Role: Test Lead - GxP Software Quality (Data Review & Data Management Platform)
Location: Hyderabad
Employment Type: Full-Time
Shift Time: UK Shift (02.00 PM to 11.00 PM IST)
Role Overview:
The Test Lead – GxP Software Quality is responsible for ensuring that all testing activities for a regulated data review and data management platform are executed in compliance with GxP requirements, internal SOPs, and Computer System Validation (CSV) standards.
This role leads end-to-end testing strategy, planning, execution, and reporting across multiple testing types, ensuring systems are fit for intended use, meet business requirements, and comply with regulatory expectations.
The Test Lead collaborates closely with Product, Engineering, Data Management, Clinical, and Independent Quality (TQ) teams to ensure inspection readiness and audit defensibility.
Required Qualifications:
Bachelor’s or Master’s degree in Computer Science, Life Sciences, or related field
8–12+ years of experience in software testing/QA, including leadership roles
Strong experience in GxP-regulated environments and Computer System Validation (CSV)
Proven experience leading:
Manual functional testing
Automation frameworks
Performance testing
UAT coordination
Experience with clinical data platforms, data review tools, or data management systems preferred
Key Responsibilities:
1. GxP Quality & Compliance Oversight:
Ensure all testing activities align with GxP regulations and internal CSV procedures (e.g., validation strategy, compliance plan, and deliverables).
Partner with Technology Quality / Independent Quality teams to support validation lifecycle compliance and audit readiness.
Enforce traceability across requirements, test cases, defects, and validation artifacts.
Ensure proper documentation, review, and approval of all test deliverables (protocols, scripts, summary reports).
2. Test Strategy & Planning:
Define and maintain the overall test strategy and test approach across releases, including:
Test levels and test types
Entry / exit criteria
Environment requirements
Risk-based testing approach
Align test strategy with compliance plans and system risk classification.
Provide estimates, resource planning, and scheduling for all testing activities.
3. Functional Testing (Manual):
Oversee design and execution of manual test cases validating:
Business requirements (user stories)
End-to-end clinical data workflows
Ensure completeness and coverage of functional testing aligned to intended system use.
Guide defect identification, triage, and resolution activities.
4. Test Automation:
Establish and lead automation strategy to improve regression coverage and efficiency.
Ensure automated test suites:
Are validated and maintainable
Align with GxP expectations (no black-box automation without traceability)
Integrate automation within CI/CD pipelines where applicable.
5. Performance Testing:
Oversee performance testing team’s activities to:
Validate system scalability and performance under load
Identify bottlenecks and system limitations
Define performance test scenarios, workloads, and acceptance criteria.
Collaborate with infrastructure and engineering teams on tuning and optimization.
6. Regression Testing:
Ensure comprehensive regression testing coverage across releases and patches.
Maintain regression test suites (manual + automated).
Ensure no unintended impact to validated functionality.
7. User Acceptance Testing (UAT) Oversight:
Coordinate and support execution of UAT with business stakeholders.
Ensure UAT validates user requirements and business process flows in real-world scenarios.
Track UAT progress, defect resolution, and formal acceptance sign-off.
8. Defect & Quality Management:
Establish defect lifecycle management processes: Logging, triaging, prioritization, and resolution tracking.
Monitor defect trends and quality metrics.
Drive root cause analysis and continuous improvement.
9. Reporting & Governance:
Provide regular reporting on:
Test progress
Quality metrics and KPIs
Risks and issues
Communicate status to project leadership and stakeholders.
Support governance forums and audit/inspection activities.
10. Cross-Functional Collaboration:
Work closely with:
Product Owners / Technical Product Managers (e.g., Data4You/MARVEL context)
Clinical Data Review and Data Management teams
Engineering and DevOps teams
Independent Quality (TQ)
Ensure alignment between testing, development, and validation deliverables.
Preferred Skills:
Knowledge of clinical systems (e.g., EDC, data review platforms like Data4You/MARVEL)
Familiarity with regulatory expectations (FDA, EMA, ICH-GCP)
Experience with test management and defect tracking tools
Strong understanding of SDLC and Agile methodologies
Excellent stakeholder communication and leadership skills
Key Competencies:
Risk-based decision-making
Attention to detail and audit readiness mindset
Strong ownership and accountability
Ability to drive quality across distributed/global teams
Continuous improvement orientation
Success Metrics:
Zero critical audit findings related to testing/validation
High defect detection effectiveness (pre-production)
On-time test execution aligned with release timelines
Strong UAT acceptance with minimal rework
Performance SLAs consistently met
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Location: Hyderabad
Employment Type: Full-Time
Shift Time: UK Shift (02.00 PM to 11.00 PM IST)
Role Overview:
The Test Lead – GxP Software Quality is responsible for ensuring that all testing activities for a regulated data review and data management platform are executed in compliance with GxP requirements, internal SOPs, and Computer System Validation (CSV) standards.
This role leads end-to-end testing strategy, planning, execution, and reporting across multiple testing types, ensuring systems are fit for intended use, meet business requirements, and comply with regulatory expectations.
The Test Lead collaborates closely with Product, Engineering, Data Management, Clinical, and Independent Quality (TQ) teams to ensure inspection readiness and audit defensibility.
Required Qualifications:
Bachelor’s or Master’s degree in Computer Science, Life Sciences, or related field
8–12+ years of experience in software testing/QA, including leadership roles
Strong experience in GxP-regulated environments and Computer System Validation (CSV)
Proven experience leading:
Manual functional testing
Automation frameworks
Performance testing
UAT coordination
Experience with clinical data platforms, data review tools, or data management systems preferred
Key Responsibilities:
1. GxP Quality & Compliance Oversight:
Ensure all testing activities align with GxP regulations and internal CSV procedures (e.g., validation strategy, compliance plan, and deliverables).
Partner with Technology Quality / Independent Quality teams to support validation lifecycle compliance and audit readiness.
Enforce traceability across requirements, test cases, defects, and validation artifacts.
Ensure proper documentation, review, and approval of all test deliverables (protocols, scripts, summary reports).
2. Test Strategy & Planning:
Define and maintain the overall test strategy and test approach across releases, including:
Test levels and test types
Entry / exit criteria
Environment requirements
Risk-based testing approach
Align test strategy with compliance plans and system risk classification.
Provide estimates, resource planning, and scheduling for all testing activities.
3. Functional Testing (Manual):
Oversee design and execution of manual test cases validating:
Business requirements (user stories)
End-to-end clinical data workflows
Ensure completeness and coverage of functional testing aligned to intended system use.
Guide defect identification, triage, and resolution activities.
4. Test Automation:
Establish and lead automation strategy to improve regression coverage and efficiency.
Ensure automated test suites:
Are validated and maintainable
Align with GxP expectations (no black-box automation without traceability)
Integrate automation within CI/CD pipelines where applicable.
5. Performance Testing:
Oversee performance testing team’s activities to:
Validate system scalability and performance under load
Identify bottlenecks and system limitations
Define performance test scenarios, workloads, and acceptance criteria.
Collaborate with infrastructure and engineering teams on tuning and optimization.
6. Regression Testing:
Ensure comprehensive regression testing coverage across releases and patches.
Maintain regression test suites (manual + automated).
Ensure no unintended impact to validated functionality.
7. User Acceptance Testing (UAT) Oversight:
Coordinate and support execution of UAT with business stakeholders.
Ensure UAT validates user requirements and business process flows in real-world scenarios.
Track UAT progress, defect resolution, and formal acceptance sign-off.
8. Defect & Quality Management:
Establish defect lifecycle management processes: Logging, triaging, prioritization, and resolution tracking.
Monitor defect trends and quality metrics.
Drive root cause analysis and continuous improvement.
9. Reporting & Governance:
Provide regular reporting on:
Test progress
Quality metrics and KPIs
Risks and issues
Communicate status to project leadership and stakeholders.
Support governance forums and audit/inspection activities.
10. Cross-Functional Collaboration:
Work closely with:
Product Owners / Technical Product Managers (e.g., Data4You/MARVEL context)
Clinical Data Review and Data Management teams
Engineering and DevOps teams
Independent Quality (TQ)
Ensure alignment between testing, development, and validation deliverables.
Preferred Skills:
Knowledge of clinical systems (e.g., EDC, data review platforms like Data4You/MARVEL)
Familiarity with regulatory expectations (FDA, EMA, ICH-GCP)
Experience with test management and defect tracking tools
Strong understanding of SDLC and Agile methodologies
Excellent stakeholder communication and leadership skills
Key Competencies:
Risk-based decision-making
Attention to detail and audit readiness mindset
Strong ownership and accountability
Ability to drive quality across distributed/global teams
Continuous improvement orientation
Success Metrics:
Zero critical audit findings related to testing/validation
High defect detection effectiveness (pre-production)
On-time test execution aligned with release timelines
Strong UAT acceptance with minimal rework
Performance SLAs consistently met
Show more Show less