Lead Consultant

ConsultantConsultantContractRemoteTeam 11-50H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

37 days ago

Salary

Not specified

8 yrs expEnglishSDLC

Job Description

• 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.

Job 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

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