User Acceptance Testing Lead

2 weeks ago

Bengaluru Chennai Hyderabad, India HCLTech Full time ₹ 1,04,000 - ₹ 1,30,878 per year

Primary Skill - Managing the planning, coordination, and execution of User Acceptance Testing (UAT) for GxP applications across Pharma domains (Clinical Trial, Safety/Pharmacovigilance, Regulatory Affairs, Quality). The role ensures business requirements are validated, compliance is maintained (GxP, 21 CFR Part 11, GDPR, ICH, GAMP 5), and systems are fit for use before production deployment.

Secondary Skill UAT, Clinical Systems, EDC, Safety systems, Regulatory affairs

Keywords – UAT Lead, Clinical UAT Lead, Safety UAT Lead, Regulatory UAT Lead

Roles and Responsibilities

Must Have

  • 10 + years experience in performing UAT and testing activities for Pharma applications
  • Develop and maintain UAT strategy, test plan, and schedule for assigned projects.
  • Lead and mentor UAT testers, business SMEs, and cross-functional participants.
  • Act as the primary liaison between business teams, IT, QA, and vendors for UAT activities.
  • Organize and facilitate defect triage meetings, ensuring timely closure of issues.
  • Provide guidance on best practices, test standards, and documentation compliance.
  • Oversee test case development, execution, and results documentation.
  • Ensure UAT activities cover workflows such as Clinical (EDC, CTMS, IRT, eTMF), Safety (Case Processing, E2B Reporting), or Regulatory (RIM, eCTD, Labeling).
  • Manage regression testing during upgrades, patches, and system integrations.
  • Review and approve UAT deliverables (test scripts, execution logs, defect logs, summary reports).
  • Ensure adherence to CSV principles, SDLC, GAMP 5, and regulatory guidelines (ICH, FDA, EMA, MHRA, PMDA).
  • Prepare UAT summary reports and provide go/no-go recommendations.
  • Support internal and external audits/inspections by providing UAT evidence.
  • Drive continuous improvement initiatives (automation, efficiency, metrics tracking).

Good to Have (secondary skills)

  • Bachelor's or Master's degree in Life Sciences, Pharmacy, Computer Science, or related field.
  • 10+ years of experience in IT testing/validation, with 3–5 years in UAT leadership.
  • Strong knowledge of GxP systems (Clinical, Safety, Regulatory, Quality).
  • Expertise in UAT processes, CSV, SDLC, and risk-based testing.
  • Hands-on experience with industry-standard tools (HP ALM, JIRA, Veeva QMS, TestRail, or similar).
  • Strong leadership, coordination, and stakeholder management skills.
  • Excellent communication, problem-solving, and documentation skills.
  • Ability to manage multiple projects and teams in a matrix organization.

Communication

  • Immaculate communication and handles multiple clients/ projects
  • Works in Consulting capacity

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