Test Lead

Job Description

We are looking for an experienced GxP Compliance Test Led to join our team in Raritan, NJ. The ideal candidate will have deep expertise in GxP regulations, computer system validation (CSV), and quality compliance within pharmaceutical or life sciences domains. The role requires leading test strategy, planning, execution, and ensuring all systems meet regulatory and compliance standards.

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.
  
  

Requirements:

• 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.