Sr Data Engineering Manager

Responsibilities

• Lead the end-to-end engineering strategy for regulatory operations, including data ingestion, transformation, and delivery.
• Serve as the data engineering Subject Matter Expert (SME) within the Integrated Product Team (IPT) to support global regulatory submissions.
• Manage the development of data pipelines, models, and metadata frameworks supporting standards such as eCTD, IDMP, and HL7.
• Implement data governance, lineage, and validation to ensure strict GxP and regulatory compliance.
• Collaborate with global regulatory affairs, clinical, and IT teams to translate submission requirements into technical solutions.
• Lead and mentor a team of data engineers and analysts using Agile and Scaled Agile (SAFe) methodologies.
• Drive innovation by evaluating emerging technologies in AI, graph data, and knowledge management for regulatory intelligence.

Requirements

• 8–12 years of experience in data engineering or architecture, with at least 3 years in a managerial capacity.
• Proven experience in the biotech or pharmaceutical industry, specifically supporting regulatory functions (FDA, EMA, etc.).
• Hands-on experience with ETL/ELT tools and cloud-based data platforms such as Databricks, AWS, Azure, or GCP.
• Deep understanding of GxP data compliance, audit requirements, and regulatory submission processes.
• Familiarity with regulatory standards and data models including eCTD, IDMP, HL7, CDISC, and xEVMPD.
• Degree in Computer Science, IT, or a related field.

Preferred Qualifications

• Scaled Agile (SAFe) certification.
• Experience with Regulatory Information Management Systems (RIMS) or Veeva Vault RIM.
• Proficiency with data visualization tools like Power BI, Tableau, or Qlik.
• Knowledge of Master Data Management (MDM) in regulated environments.

About the Company

Amgen is a leading biotechnology company that harnesses the best of biology and technology to fight the world’s toughest diseases. For over 40 years, Amgen has been at the cutting edge of innovation, discovering and delivering medicines that help millions of patients worldwide.