Lead Consultant
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Job Description
CSA Lead Consultant providing leadership and oversight for computer system assurance in SAP environments. Collaborating with stakeholders on validation and governance strategies.
Responsibilities:
- 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
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