Role & seniority
- SAP S/4HANA QA Validation Lead (validation leadership; mentoring required)
- 5 openings; long-term contract
Location & work type
- Foster City, CA OR Raleigh, NC — Onsite
- Local candidates preferred
Stack/tools
- SAP S/4HANA (validation for projects/enhancements/releases/interfaces/reports/data migrations)
- GxP / CSV frameworks and computerized system validation documentation
- Quality/defect lifecycle tooling (defect logging/classification/triage/aging, metrics/KPIs, dashboards) — tool unspecified
Top 3 responsibilities
- Define and govern enterprise S/4HANA validation strategy, methodology, standards, templates, and lifecycle approach
- Lead risk-based validation assessments and ensure end-to-end traceability (requirements → testing → defect resolution → release approval)
- Govern defect lifecycle and drive governance-level reviews (severity/priority, triage, aging, RCA, escalation, readiness recommendations)
Must-have skills
- Deep CSV/GxP compliance knowledge (data integrity, validation evidence, documentation, audit/inspection readiness)
- Ability to lead validation governance across SAP functional streams and integrated systems
- Strong risk-based validation planning/execution and requirements traceability
- Defect management governance: classification, triage, closure criteria, escalation, trend/risk visibility
Nice-to-haves
- E

Full Description

Job Title: SAP S/4HANA QA Validation Lead

Location: Foster City, CA OR Raleigh, NC - Onsite

Duration: Long Term

Industry: Pharma/Life Sciences

No. of positions: 5

(Locals preferred)

Key Accountabilities

Define and maintain the enterprise SAP S/4HANA validation strategy and governance framework.
Support establishing validation standards, procedures, templates, and best practices aligned with regulatory requirements and company SOPs.
Lead risk-based validation assessments for projects, enhancements, releases, interfaces, reports, and data migrations.
Establish and govern the Validation approach, methodology, Validation planning and standards.
Govern validation lifecycle execution from requirements through release approval.
Drive standardization of validation methodologies across SAP functional streams and integrated systems.
Ensure compliance with GxP regulations, computerized system validation requirements, data integrity principles, and corporate quality policies.
Ensure appropriate documentation, traceability, and validation evidence are maintained.
Define and govern defect lifecycle, logging, classification, severity and priority, triage, aging, service-level expectations, root cause analysis, duplicate and invalid handling, and deferral controls.
Facilitate governance-level defect reviews and escalate quality risks, unresolved critical defects, overdue actions, and decision gaps.
Ensure defect trends and risk exposure are visible to accountable stakeholders and appropriately considered in readiness decisions.
Define and maintain Validation metrics, KPIs, dashboards, and report standards for execution progress, coverage, defects, aging, trends, automation, risks, and readiness.
Review validation documentation for completeness, accuracy, and compliance.
Ensure end-to-end requirements traceability from requirements through testing and defect resolution.
Ensure appropriate defect management, triage, remediation, and closure criteria are achieved.
Support implementation of quality gates and entry/exit criteria across validation phases.
Participate in SAP Change Control and CAB reviews.
Ensure validation activities are integrated into release and deployment plans.
Provide release readiness recommendations and validation sign-off.
Facilitate governance reviews, steering meetings, risk assessments, and compliance reviews.
Mentor Validation engineers and project validation resources.
Support SAP team for Audit and inspection readiness activities.
Support continuous improvement initiatives for S4 HANA validation processes, automation, and governance maturity.