About this role
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 strong 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 environments. • 3+ years of experience leading validation teams, validation programs, or quality compliance initiatives. • Experience supporting regulated systems throughout the software development lifecycle (SDLC).
Preferred Qualifications
• Experience leading validation activities for global, enterprise-scale digital platforms. • Experience implementing Computer Software Assurance (CSA) and risk-based validation methodologies. • Experience validating cloud-based and SaaS platforms. • Experience supporting Agile and product-centric delivery organizations. • Experience driving validation automation and digital transformation initiatives in Life Sciences domain.
Required Skills
• Computer System Validation (CSV) expertise. • Strong knowledge of GxP regulations, FDA 21 CFR Part 11, Annex 11, and Data Integrity requirements. • Validation lifecycle management including Validation Plans, Risk Assessments, RTM, IQ/OQ/PQ, and VSRs. • Requirements Traceability Matrix (RTM) creation, governance, and compliance management. • Risk-based validation and test strategy development. • Audit and inspection readiness management. • Quality Management Systems (QMS), CAPA, deviation, and change control processes. • Validation management tools such as ALM, Jira, Validation Management (VM), or equivalent platforms.
Good-to-Have Skills
• Computer Software Assurance (CSA). • GAMP 5 methodology. • Validation of Salesforce, Mulesoft, cloud, and SaaS solutions. • Automated testing and validation frameworks. • DevOps, CI/CD, and release management practices. • Quality metrics, KPI reporting, and trend analysis.
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