Specialist IS Business Analyst

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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