Career Category
Information Systems
Job Description
Position Summary
Lead the validation team in a GMP High Salesforce application and serve as the accountable leader for validation governance, GxP compliance, RTM traceability, inspection readiness, and quality oversight. Drive compliant delivery through robust validation leadership, risk-based decision making, and operational excellence while developing a high-performing validation team.
Key Responsibilities
Lead validation strategy, governance, and execution for GxP-regulated applications, computerized systems, and digital platforms.
Ownership & oversight for validation activities, ensuring compliance with internal SOPs, regulatory requirements, and industry standards.
Author & ownership of validation deliverables including Validation Plans, Risk Assessments, IQ/OQ/PQ Protocols, Validation Summary Reports (VSRs), and Requirements Traceability Matrices (RTMs).
Establish and maintain end-to-end traceability between requirements, risks, test evidence, defects, and compliance documentation through RTM governance.




Ensure inspection of readiness and support internal audits, regulatory inspections, CAPA, deviation management, and change control activities.
Complete ownership of validation strategy, testing scope and end-to-end system validation.
Lead and mentor Validation Engineers, establishing best practices and driving a quality-first culture.
Partner with Product, Business, Quality, Regulatory, and Technology teams to support compliant and timely delivery of business initiatives.
Drive continuous improvement initiatives to reduce validation cycle time while maintaining compliance and quality standards.

Basic Qualifications
Bachelor's or Master's degree in Computer Science, Engineering, Information Systems, Life Sciences, Biotechnology, Pharmaceutical Sciences, or related discipline.
8+ years of experience in Computer System Validation (CSV), Quality Assurance, or GxP-regulated settings.
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