QMS Specialist (Business Architect)

Amgen; India; On-site; INR 2,500,000 - 4,000,000; Full time

Job summary

Amgen is seeking an experienced Veeva QMS Configuration Lead to own configuration, enhancement, and operational support of Veeva Vault QMS capabilities. You will partner with integration teams to deliver reliable enterprise quality solutions and translate business requirements into scalable Vault configurations.

The role focuses on hands-on Veeva QMS configuration, solution design, and production sustainment with strong compliance, traceability, and regulatory readiness across rapid release

Qualifications

• Bachelor's degree in Computer Science, Information Systems, Engineering is required.
• Experience with Veeva Vault QMS configuration and integrations.
• Strong knowledge of API integrations and data workflows.
• Experience in regulated life sciences environments is desirable.

Responsibilities

• Lead configuration design and implementation for Veeva Vault QMS, including workflows, lifecycles, object models, and security rules.
• Partner with integration teams to define and support API integrations and data mappings.
• Translate business requirements into Vault QMS configurations supporting deviations, CAPA, change control, and audits.
• Lead technical implementation and configuration activities for QMS workflows, integrations, and reporting.

Skills

Veeva Vault QMS

Workflow design

APIs

MuleSoft

Education

Bachelor's degree in Computer Science, Information Systems, Engineering

Tools

Databricks

Apache Spark

PySpark

Delta Lake

Job 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