Sr Data Engineering Manager
Amgen
Sr Data Engineering Manager
Job Description
ABOUT AMGEN
What you will do
- 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.
What we expect of you
- 8–12 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.
- 12 to 15 years of experience in Computer Science, IT or related field.
- Scaled Agile SAFe certification preferred.
- Project Management certifications preferred.
Must-Have Skills
- Excellent analytical and troubleshooting skills.
- Strong verbal and written communication skills.
- Ability to work effectively with global, virtual teams.
- High degree of initiative and self-motivation.
- Ability to manage multiple priorities successfully.
- Team-oriented, with a focus on achieving team goals.
- Strong presentation and public speaking 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.
Compensation
8–12
Locations
- Hyderabad, India
Salary
Salary not disclosed
Estimated Salary Rangehigh confidence
80,000 - 120,000 USD / yearly
Source: xAI estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Excellent analytical and troubleshooting skills.intermediate
- Strong verbal and written communication skills.intermediate
- Ability to work effectively with global, virtual teams.intermediate
- High degree of initiative and self-motivation.intermediate
- Ability to manage multiple priorities successfully.intermediate
- Team-oriented, with a focus on achieving team goals.intermediate
- Strong presentation and public speaking skills.intermediate
- Prior experience working on integrated product teams or regulatory transformation programs.intermediate
- Knowledge of Regulatory Information Management Systems (RIMS), Veeva Vault RIM, or Master Data Management (MDM) in regulated environments.intermediate
- Familiarity with Agile/SAFe methodologies and DevOps/DataOps best practices.intermediate
Required Qualifications
- 8–12 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. (experience)
- Proven experience supporting regulatory functions, including submissions, tracking, and reporting for FDA, EMA, and other global authorities. (experience)
- Experience with ETL/ELT tools, data pipelines, and cloud-based data platforms (e.g., Databricks, AWS, Azure, or GCP). (experience)
- Familiarity with regulatory standards and data models such as eCTD, IDMP, HL7, CDISC, and xEVMPD. (experience)
- Deep understanding of GxP data compliance, audit requirements, and regulatory submission processes. (experience)
- Experience with tools like Power BI, Tableau, or Qlik for regulatory dashboarding and visualization is a plus. (experience)
- Strong project management, stakeholder communication, and leadership skills, especially in matrixed, cross-functional environments. (experience)
- Ability to translate technical capabilities into regulatory and business outcomes. (experience)
- Prepare team members for stakeholder discussions by helping assess data costs, access requirements, dependencies, and availability for business scenarios. (experience)
- 12 to 15 years of experience in Computer Science, IT or related field. (experience)
- Scaled Agile SAFe certification preferred. (experience)
- Project Management certifications preferred. (experience)
Responsibilities
- 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.
Tags & Categories
Sr Data Engineering Manager
Amgen
Sr Data Engineering Manager
Job Description
ABOUT AMGEN
What you will do
- 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.
What we expect of you
- 8–12 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.
- 12 to 15 years of experience in Computer Science, IT or related field.
- Scaled Agile SAFe certification preferred.
- Project Management certifications preferred.
Must-Have Skills
- Excellent analytical and troubleshooting skills.
- Strong verbal and written communication skills.
- Ability to work effectively with global, virtual teams.
- High degree of initiative and self-motivation.
- Ability to manage multiple priorities successfully.
- Team-oriented, with a focus on achieving team goals.
- Strong presentation and public speaking 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.
Compensation
8–12
Locations
- Hyderabad, India
Salary
Salary not disclosed
Estimated Salary Rangehigh confidence
80,000 - 120,000 USD / yearly
Source: xAI estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Excellent analytical and troubleshooting skills.intermediate
- Strong verbal and written communication skills.intermediate
- Ability to work effectively with global, virtual teams.intermediate
- High degree of initiative and self-motivation.intermediate
- Ability to manage multiple priorities successfully.intermediate
- Team-oriented, with a focus on achieving team goals.intermediate
- Strong presentation and public speaking skills.intermediate
- Prior experience working on integrated product teams or regulatory transformation programs.intermediate
- Knowledge of Regulatory Information Management Systems (RIMS), Veeva Vault RIM, or Master Data Management (MDM) in regulated environments.intermediate
- Familiarity with Agile/SAFe methodologies and DevOps/DataOps best practices.intermediate
Required Qualifications
- 8–12 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. (experience)
- Proven experience supporting regulatory functions, including submissions, tracking, and reporting for FDA, EMA, and other global authorities. (experience)
- Experience with ETL/ELT tools, data pipelines, and cloud-based data platforms (e.g., Databricks, AWS, Azure, or GCP). (experience)
- Familiarity with regulatory standards and data models such as eCTD, IDMP, HL7, CDISC, and xEVMPD. (experience)
- Deep understanding of GxP data compliance, audit requirements, and regulatory submission processes. (experience)
- Experience with tools like Power BI, Tableau, or Qlik for regulatory dashboarding and visualization is a plus. (experience)
- Strong project management, stakeholder communication, and leadership skills, especially in matrixed, cross-functional environments. (experience)
- Ability to translate technical capabilities into regulatory and business outcomes. (experience)
- Prepare team members for stakeholder discussions by helping assess data costs, access requirements, dependencies, and availability for business scenarios. (experience)
- 12 to 15 years of experience in Computer Science, IT or related field. (experience)
- Scaled Agile SAFe certification preferred. (experience)
- Project Management certifications preferred. (experience)
Responsibilities
- 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.
Tags & Categories