SAP Validation Lead

We are seeking an experienced SAP Validation Lead to drive Computer System Validation (CSV) efforts for SAP systems in a regulated environment. The ideal candidate will ensure SAP implementations and enhancements comply with GxP, FDA 21 CFR Part 11, Annex 11, and industry validation standards.
This role requires deep expertise in SAP validation, SDLC methodologies, risk-based validation approaches, and change management processes. You will collaborate closely with Business, IT, QA, and Regulatory stakeholders to ensure compliance, system integrity, and data reliability.

Key Responsibilities
SAP System Validation & Compliance
Lead end-to-end validation of SAP systems in line with GxP, 21 CFR Part 11, Annex 11, and ALCOA+ principles.
Develop and execute validation strategies, IQ, OQ, PQ protocols, and test scripts.
Ensure documentation aligns with GAMP 5, FDA, and industry standards.
Validation Documentation & Risk Assessment
Author, review, and approve URS, FRS, Risk Assessments, Validation Plans, Test Scripts, and Reports.
Conduct impact assessments, risk evaluations, and periodic system reviews.
Change Control & Incident Management
Lead Change Control assessments for SAP updates, patches, and customizations.
Ensure incident management, deviations tracking, and CAPA resolution.
Collaboration & Stakeholder Management
Partner with Business, IT, and QA teams to align validation with business needs.
Act as the SAP Validation SME during internal and external audits.
System Decommissioning & Lifecycle Management
Oversee system decommissioning with full compliance and documentation.
Drive continuous improvement for validation processes.