ilb Consulting Services

Lead Consultant

ilb Consulting Services

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Location Type: Remote

Location: United States

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Job Level

Senior

Tech Stack

SDLC

About the role

  • Lead development of the validation strategy within the first 30 days of onboarding.
  • Oversee CSA compliance execution aligned with the customer SDLC and quality procedures.
  • Provide governance, review, and approval of validation lifecycle deliverables (URS, risk assessments, validation plans, specifications, testing artifacts, traceability, and validation summary).
  • Ensure readiness for formal testing and completeness of change control documentation.
  • Support CMDB governance and provide guidance on validation and testing tools.
  • Monitor KPI adherence including approval cycle time and traceability coverage.

Requirements

  • ~8–12+ years in Computer System Validation (CSV) / Computer System Assurance within regulated life sciences.
  • Demonstrated leadership of validation strategy, lifecycle deliverables, and SDLC compliance.
  • Strong experience with SAP or enterprise platform validation in GxP environments.
  • Proven ability to review/approve validation documentation and oversee testing governance.
  • Experience working remotely with global stakeholders.
Benefits
  • Competitive C2C 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Computer System ValidationComputer System Assurancevalidation strategyvalidation lifecycle deliverablesSDLC compliancevalidation documentation reviewtesting governanceKPI monitoringrisk assessmentsGxP environments
Soft Skills
leadershipcommunicationcollaborationguidanceoversight