**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. + Robust 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.

📌 Specialist IS Business Analyst (Hyderabad)
🏢 AMGEN
📍 Hyderabad