AM
AmgenSpecialist IS Business Analyst
LocationIndia - Hyderabad
Work modeon-site
Typefull-time
SeniorityLead
Experience8+ yrs
DepartmentInformation Systems
Company size10,000+ people
PostedSep 15, 2026 · 4w ago
Verified live1d ago
At a glanceSummarised by Seekless from the posting.
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)
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
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
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
Skills
Salesforce
Mulesoft
ALM
Jira
Validation Management (VM)
cloud-based platforms
SaaS platforms
GAMP 5
CI/CD
DevOps
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
Nice to have
•
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.
.