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, with proven ability to review/approve validation documentation and oversee testing governance
Experience supporting S/4HANA upgrades or large enterprise transformation programs
Requirements:
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
Job description
Summary:
The CSA Lead provides leadership and execution oversight for computer system assurance and validation activities supporting SAP Unify Release 1.0 and 1.5. The role is responsible for validation strategy definition, lifecycle governance, and alignment with SDLC, quality, and documentation expectations while collaborating closely with Digital Quality, System Owners, and Business Process Owners.
Roles & 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.
Education & Experience:
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
Experience supporting S/4HANA upgrades or large enterprise transformation programs.
Familiarity with ALCOA+ documentation principles and quality governance frameworks.
Prior lead or architect-level CSA/CSV role
