Amgen—QMS Specialist

Job description

Description: Career Category Quality Job Description Role Overview We are looking for an experienced Veeva QMS Configuration Lead to own the configuration, enhancement, and operational support of Veeva Vault QMS capabilities while partnering closely with integration, data, and platform teams to deliver reliable enterprise quality solutions. This is a lead-level configuration and integration services role focused on hands-on Veeva QMS configuration, solution design, workflow enablement, integration readiness, release support, and production sustainment. The ideal candidate must be able to independently translate business and quality process requirements into scalable Vault configurations, partner with technical teams on APIs and integration services, and ensure solutions are delivered with strong compliance, traceability, and operational discipline. The role requires deep functional and technical understanding of Veeva Vault QMS configuration, strong integration services knowledge, and the ability to lead cross-functional delivery in a regulated life sciences environment. Key Responsibilities Veeva QMS Configuration Leadership & Integration Services - Lead configuration design and implementation for Veeva Vault QMS, including workflows, lifecycles, object models, page layouts, document and quality process configurations, security, roles, and business rules. - Partner with integration teams to define, validate, and support Veeva integration services, including APIs, MuleSoft services, data mappings, event handling, authentication, and error management. - Translate business requirements into effective Vault QMS configurations that support deviations, CAPA, change control, audits, complaints, quality events, and related quality processes. - Provide hands-on configuration expertise across: - Vault objects, fields, layouts, and related object relationships - Workflows, lifecycles, states, roles, and permissions - Reports, dashboards, notifications, and controlled configuration changes - Integration touchpoints, source-to-target mappings, and validation support - Release deployment, migration packages, and environment configuration management - Support API-enabled integrations, authentication, logging, monitoring, exception handling, and retry mechanisms in partnership with integration service teams. - Troubleshoot and resolve configuration, workflow, integration, and data issues across development, test, validation, and production environments. Databricks Engineering & Data Pipelines - Build and support scalable data pipelines using: - Databricks - Apache Spark - PySpark - Spark SQL - Delta Lake - Independently configure and manage: - Databricks Workflows - Job scheduling - Clusters - Notebooks - Databases and schemas - Delta tables - Unity Catalog / Data Marketplace catalogs - Develop automated workflows for ingestion, transformation, validation, and deployment of enterprise datasets. - Implement monitoring, alerting, and operational support for production data pipelines. - Apply performance optimization techniques including: - Spark job tuning - Partitioning - Caching - Query optimization - Parallel processing - Develop reusable frameworks and automation utilities to improve platform efficiency and scalability. Veeva Vault QMS Configuration Ownership - Own and deliver configured solutions on the Veeva Vault platform, including: - Veeva Vault Quality configuration - QMS process configuration and workflow design - Quality Docs configuration dependencies and cross-vault process alignment - Vault Admin, Vault Loader, and configuration migration capabilities - Lead technical implementation and configuration activities related to Veeva QMS workflows, integrations, reporting, and controlled releases. - Drive system enhancements, release impact assessments, configuration deployments, validation support, and operational sustainment activities. - Ensure configurations, integrations, and data flows maintain quality process integrity, traceability, audit readiness, and compliance standards. Cloud, DevOps & Platform Engineering - Work with AWS/cloud-native technologies to build scalable and reliable data engineering solutions. - Support CI/CD pipelines, source control, and automated deployments using tools such as: - GitHub - Jenkins - Maven - Git - Collaborate with architecture and platform teams to implement enterprise engineering standards and best practices. - Support change management, release deployments, environment setup, and production support activities. Agile Delivery & Collaboration - Work closely with Data Engineers, Architects, Quality teams, Product Owners, and Business SMEs to understand requirements and deliver technical solutions. - Participate in Agile ceremonies including sprint planning, estimations, technical discussions, and code reviews. - Perform root cause analysis and provide timely resolution for production issues. - Collaborate effectively with global teams across multiple time zones. Required Qualifications Required Experience - Bachelor’s degree in Computer Science, Information Systems, Engineering, or related technical field. - 8-12 years of experience in enterprise application configuration, quality systems implementation, integration services, or regulated technology delivery. - Strong hands-on configuration and technical delivery experience with: - Veeva Vault QMS configuration - Veeva Vault administration and release configuration - Integration services and API-enabled solution delivery - MuleSoft or equivalent enterprise integration platforms - Data flows, reporting, validation, and production support - Experience delivering Veeva QMS solutions that integrate with enterprise applications, data platforms, and downstream reporting or analytics capabilities. - Experience supporting regulated change control, testing, validation documentation, and production sustainment for GxP systems. Required Technical Skills - Strong hands-on expertise with: - Veeva Vault QMS configuration - Vault objects, workflows, lifecycles, layouts, roles, permissions, and business rules - Vault Loader, configuration migration, and environment management - Veeva APIs and integration services - MuleSoft Anypoint Platform or equivalent integration middleware - REST/SOAP APIs, authentication, logging, monitoring, and exception handling - Data mapping, interface validation, and end-to-end integration testing - Quality process configuration for deviations, CAPA, change control, audits, and complaints - GxP validation support, controlled documentation, and audit readiness - Strong ability to analyze business processes and convert them into scalable, maintainable Veeva Vault configurations. - Hands-on experience configuring: - Veeva workflows and lifecycle states - Object models, fields, layouts, and relationships - Security models, roles, permissions, and sharing rules - Reports, dashboards, notifications, and user actions - Configuration migration, deployment readiness, and environment comparison - Experience supporting integration service design, interface testing, issue triage, and production monitoring for connected enterprise systems. - Strong understanding of: - Veeva QMS business processes - Regulated quality system delivery - Data integrity, traceability, and audit readiness - Change control, release management, and production sustainment Preferred Skills - Advanced experience with Veeva Vault Quality/QMS configuration and administration. - Experience in Life Sciences or GxP-regulated environments with strong understanding of quality processes. - Familiarity with GDPR, CCPA, and enterprise compliance requirements. - Experience with Veeva reporting, dashboards, analytics handoffs, and downstream data consumption. - Exposure to enterprise data platforms, Databricks, or AI-enabled capabilities that support quality data insights. Preferred Certifications - Databricks Certification - MuleSoft Certified Developer - AWS Certified Data Engineer or Solutions Architect - Veeva Vault Certification Soft Skills - Strong hands-on problem-solving and troubleshooting mindset. - Self-driven engineer who can independently own technical delivery. - Excellent communication and collaboration skills. - Ability to work in fast-paced Agile delivery environments. - Strong analytical and debugging capabilities. - Ability to balance development, support, and delivery responsibilities effectively. .