Katalyst CRO · 2 months ago
Test Lead
Raritan, NJ
Contract
Onsite
Senior Level, Lead/Staff
8+ years expKatalyst CRO is seeking an experienced GxP Compliance Test Lead to join their team. The role involves leading test strategy, planning, execution, and ensuring all systems meet regulatory and compliance standards in the pharmaceutical or life sciences domains.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Lead and oversee all GxP testing activities for applications within regulated environments
Develop and implement test strategies, plans, and protocols in alignment with FDA, GAMP5, and 21 CFR Part 11 standards
Manage end-to-end validation lifecycle including test planning, execution, defect tracking, and reporting
Collaborate with QA, business analysts, developers, and validation teams to ensure compliance with quality requirements
Review and approve test documentation including Validation Plans (VP), Traceability Matrix, Test Summary Reports, and Risk Assessments
Conduct and support internal and external audits related to software validation and testing
Mentor and guide junior QA/testers on GxP best practices and compliance procedures
Qualification
Required
Bachelor's degree in computer science, Information Technology, or a related discipline
8+ years of experience in software testing and GxP compliance, with 3+ years in a lead capacity
Hands-on experience in Computer System Validation (CSV) and Regulated Testing Environments (Life Sciences, Pharma, Medical Devices)
Strong understanding of GAMP5, FDA 21 CFR Part 11, Annex 11, and ICH Q10 guidelines
Proficiency in test management tools (e.g., Client ALM, Jira, Zephyr)
Excellent documentation, stakeholder communication, and problem-solving skills
Strong analytical and leadership capabilities
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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