Full-Time
Quality Management Systems Specialist
Business Architect
Updated on 9/12/2026
Amgen
10,001+ employees
Biotech company creating biologic medicines
No salary listed
Hyderabad, Telangana, India
In Person
Bachelor's
 IT Operations (1) |
|---|
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- A bachelor's degree in Computer Science, Information Systems, Engineering, or a related technical field.
- Eight to twelve years of experience in enterprise application configuration, quality systems implementation, integration services, or regulated technology delivery.
- Strong hands-on experience with Veeva Vault QMS configuration, Veeva Vault administration and release configuration, integration services, API-enabled solution delivery, MuleSoft or equivalent enterprise integration platforms, data flows, reporting, validation, and production support.
- Experience delivering Veeva QMS solutions integrated 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.
- 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 and 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; and GxP validation support, controlled documentation, and audit readiness.
- 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; and 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, audit readiness, change control, release management, and production sustainment.
- 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 Vault QMS configurations supporting deviations, CAPA, change control, audits, complaints, quality events, and related quality processes.
- Provide hands-on configuration across Vault objects, fields, layouts, object relationships, workflows, lifecycles, states, roles, permissions, reports, dashboards, notifications, controlled configuration changes, integration touchpoints, source-to-target mappings, validation support, release deployment, migration packages, and environment configuration management.
- Support API-enabled integrations, authentication, logging, monitoring, exception handling, and retry mechanisms with integration service teams.
- Troubleshoot and resolve configuration, workflow, integration, and data issues across development, test, validation, and production environments.
- Build and support scalable data pipelines using Databricks, Apache Spark, PySpark, Spark SQL, and Delta Lake.
- Configure and manage Databricks Workflows, job scheduling, clusters, notebooks, databases and schemas, Delta tables, and Unity Catalog or 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, and parallel processing.
- Develop reusable frameworks and automation utilities to improve platform efficiency and scalability.
- 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, cross-vault process alignment, Vault Admin, Vault Loader, and configuration migration.
- 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.
- Work with AWS and cloud-native technologies to build scalable and reliable data engineering solutions.
- Support CI/CD pipelines, source control, and automated deployments using GitHub, Jenkins, Maven, and 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.
- Work 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 with global teams across multiple time zones.
- 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 supporting quality data insights.
- Databricks Certification.
- MuleSoft Certified Developer.
- AWS Certified Data Engineer or Solutions Architect.
- Veeva Vault Certification.
Amgen develops medicines that treat serious illnesses by using biologic therapies made from living cells. These therapies are designed to target specific disease processes, such as cancer, cardiovascular disease, and autoimmune conditions, and are produced through biotechnology methods that create proteins or antibodies. Amgen’s products are sold to patients and healthcare providers worldwide, with revenue funding ongoing research and development to discover new treatments. The company stands out by focusing on biologic medicines at a large scale and maintaining a steady pipeline of potential therapies across multiple disease areas, supported by global manufacturing and a commitment to bringing therapies to patients. Its goal is to improve patient outcomes by discovering and delivering new, effective treatments while reinvesting a significant portion of earnings into research and development.
Company Size
10,001+
Company Stage
IPO
Headquarters
Thousand Oaks, California
Founded
1980
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Simplify's Take
What believers are saying
- Q2 2026 revenue rose 10% to $10.1 billion, and guidance increased to $38.2 billion-$39.4 billion.
- Repatha sales jumped 37% to $953 million in Q2 2026, with U.S. prescriptions up 50%.
- MariTide advanced through multiple Phase 3 studies in 2026, supporting a 2027 obesity catalyst.
What critics are saying
- Prolia sales fell 32% in Q2 2026 as biosimilars attack Amgen’s legacy cash cow.
- FDA proposed withdrawing Tavneos in April 2026, signaling regulatory risk from integrity and efficacy issues.
- Olpasiran now faces Novartis pelacarsen failure scrutiny; a negative 2028 OCEAN(a) readout would crush Lp(a) upside.
What makes Amgen unique
- Repatha, Evenity, and Uplizna diversify Amgen beyond one blockbuster, per August 2026 sales.
- MariTide targets quarterly or eight-week dosing, unlike Lilly and Novo Nordisk weekly injections.
- Amgen’s 2027 Hyderabad Science and Innovation Center expands AI-enabled drug discovery globally.
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Company News
Amgen trades at $393 per share, representing a trailing multiple of 23.3 times adjusted earnings. The biotech faces declining sales from Prolia and XGEVA, down 33% year-over-year to $1.1 billion in Q2 2026, due to biosimilar competition. Six key growth medicines grew 26% year-over-year, accounting for nearly 70% of Q2 product sales. Analysts forecast the forward multiple at 17.0 times for fiscal 2026 and 16.1 times for 2027. However, consensus assumes expanding profit margins whilst Amgen increases spending. Non-GAAP research spending is set to grow in high single digits for 2026, funding nine Phase III trials for MariTide, its obesity treatment candidate. Management warned of meaningful operating expense increases in Q3 2026. The valuation depends on margin expansion materialising during this investment phase.
Amgen faces heightened scrutiny for its experimental heart drug olpasiran after rival Novartis's pelacarsen failed to reduce major cardiovascular events in a Phase 3 trial, despite successfully lowering lipoprotein(a) levels. The setback demonstrates that improving laboratory biomarkers may not translate to better patient outcomes. Amgen's OCEAN(a) outcomes study has enrolled 7,297 participants and is tracking heart-related deaths and procedures over roughly five years. While olpasiran uses a different design and may target different patients, pelacarsen's failure removes assumptions about the commercial value of lowering Lp(a). Amgen's shares traded at $437.23, sitting 19.54% above its estimated fair value of $365.76. The company reported $10.1 billion in second-quarter revenue and $3.5 billion in free cash flow.
Jim Cramer highlighted Amgen's cholesterol drug Repatha as a key driver behind the company's 31% year-to-date rally, calling it an overlooked catalyst by Wall Street. The injectable treatment, administered every two weeks, reduces death risk by 20% in patients at high risk for heart attack or stroke. Repatha generated $953 million in second-quarter sales, up 37% year-over-year. US new prescriptions surged over 50%, split evenly between cardiologist use and primary-care adoption for high-risk patients. Cramer noted the drug works against diabetes and high cholesterol, though insurance reimbursement has posed challenges. Amgen trades at a forward PE of 19, compared to Eli Lilly's 32, whilst outperforming Lilly's 10% gain this year. Repatha is one of six growth drivers representing nearly 70% of Amgen's product sales. The company raised full-year revenue guidance to $38.2-$39.4 billion.
Amgen shares jumped 3.5% to $440.08 on Wednesday as healthcare stocks reached record highs. The biotech company reported second-quarter revenue of $10.1 billion, up 10%, whilst GAAP earnings surged 65% to $4.37 per share. Twenty-two of Amgen's medicines posted double-digit sales growth, with seventeen products generating over $1 billion in annualised sales. Six key growth products climbed 26% and now account for nearly 70% of product revenue. The rally came as investors rotated into healthcare following excitement around Merck and Moderna's melanoma breakthrough. However, Amgen now trades at a 19% premium to its fair value estimate of $365.04, putting pressure on execution as some products like Prolia face headwinds.
Amgen and Regeneron could benefit from surging demand for GLP-1 drugs, which traditionally treated diabetes but now address obesity and obstructive sleep apnea. Amgen's stock is up 27% this year, with second-quarter revenue rising 10% year-over-year to $10.1 billion. The company is testing MariTide, an investigational GLP-1 medicine, in phase 3 studies for weight management and diabetes. MariTide could be administered monthly or less frequently, offering a convenience advantage over current daily or weekly treatments. Regeneron is also positioned to capitalise on the GLP-1 market expansion. Both companies present alternatives to current market leaders Eli Lilly and Novo Nordisk for investors seeking exposure to the growing GLP-1 drug category.