Sr Data Engineering Manager

Career Category Information SystemsABOUT AMGENAmgen harnesses the best of biology and technology to fight the worlds toughest diseases and make peoples lives easier fuller and longer We discover develop manufacture and deliver innovative medicines to help millions of patients Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation using technology and human genetic data to push beyond whats known today ABOUT THE ROLERole Description We are seeking a Senior Data Engineering Manager with a strong background in Regulatory or Integrated Product Teams within the Biotech or Pharmaceutical domain This role will lead the end-to-end data strategy and execution for regulatory product submissions lifecycle management and compliance reporting ensuring timely and accurate delivery of regulatory data assets across global markets You will be embedded in a cross-functional Regulatory Integrated Product Team IPT and serve as the data and technology lead driving integration between scientific regulatory and engineering functions to support submission-ready data and regulatory intelligence solutions Roles Responsibilities Functional Skills Lead the engineering strategy and implementation for end-to-end regulatory operations including data ingestion transformation integration and delivery across regulatory systems Serve as the data engineering SME in the Integrated Product Team IPT to support regulatory submissions agency interactions and lifecycle updates Collaborate with global regulatory affairs clinical CMC quality safety and IT teams to gather submission data requirements and translate them into data engineering solutions Manage and oversee the development of data pipelines data models and metadata frameworks that support submission data standards e g eCTD IDMP SPL xEVMPD Enable integration and reporting across regulatory information management systems RIMS EDMS clinical trial systems and lab data platforms Implement data governance lineage validation and audit trails for regulatory data workflows ensuring GxP and regulatory compliance Guide the development of automation solutions dashboards and analytics that improve visibility into submission timelines data quality and regulatory KPIs Ensure interoperability between regulatory data platforms and enterprise data lakes or lakehouses for cross-functional reporting and insights Collaborate with IT data governance and enterprise architecture teams to ensure alignment with overall data strategy and compliance frameworks Drive innovation by evaluating emerging technologies in data engineering graph data knowledge management and AI for regulatory intelligence Lead mentor and coach a small team of data engineers and analysts fostering a culture of excellence innovation and delivery Drive Agile and Scaled Agile SAFe methodologies managing sprint backlogs prioritization and iterative improvements to enhance team velocity and project delivery Stay up-to-date with emerging data technologies industry trends and best practices ensuring the organization leverages the latest innovations in data engineering and architecture Must-Have Skills 812 years of experience in data engineering or data architecture with 3 years in a senior or managerial capacity preferably within the biotech or pharmaceutical industry Proven experience supporting regulatory functions including submissions tracking and reporting for FDA EMA and other global authorities Experience with ETL ELT tools data pipelines and cloud-based data platforms e g Databricks AWS Azure or GCP Familiarity with regulatory standards and data models such as eCTD IDMP HL7 CDISC and xEVMPD Deep understanding of GxP data compliance audit requirements and regulatory submission processes Experience with tools like Power BI Tableau or Qlik for regulatory dashboarding and visualization is a plus Strong project management stakeholder communication and leadership skills especially in matrixed cross-functional environments Ability to translate technical capabilities into regulatory and business outcomes Prepare team members for stakeholder discussions by helping assess data costs access requirements dependencies and availability for business scenarios Good-to-Have Skills Prior experience working on integrated product teams or regulatory transformation programs Knowledge of Regulatory Information Management Systems RIMS Veeva Vault RIM or Master Data Management MDM in regulated environments Familiarity with Agile SAFe methodologies and DevOps DataOps best practices Education and Professional Certifications12 to 15 years of experience in Computer Science IT or related fieldScaled Agile SAFe certification preferredProject Management certifications preferredSoft Skills Excellent analytical and troubleshooting skillsStrong verbal and written communication skillsAbility to work effectively with global virtual teamsHigh degree of initiative and self-motivationAbility to manage multiple priorities successfullyTeam-oriented with a focus on achieving team goalsStrong presentation and public speaking skillsEQUAL OPPORTUNITY STATEMENTAmgen is an Equal Opportunity employer and will consider you without regard to your race color religion sex sexual orientation gender identity national origin protected veteran status or disability status We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment Please contact us to request an accommodation