Sr Data Engineering Manager

Roles & Responsibilities: Functional Skills

• Engineering Strategy & Implementation: Lead the engineering strategy and implementation for end-to-end regulatory operations. This includes data ingestion, transformation, integration, and delivery across regulatory systems.
• Data Engineering SME: Serve as the data engineering Subject Matter Expert (SME) in the Integrated Product Team (IPT) to support regulatory submissions, agency interactions, and lifecycle updates.
• Cross-Functional Collaboration: Collaborate with global regulatory affairs, clinical, CMC, quality, safety, and IT teams to gather submission data requirements and translate them into robust data engineering solutions.
• Data Management & Oversight: Manage and oversee the development of data pipelines, data models, and metadata frameworks that support submission data standards (for example, eCTD, IDMP, SPL, xEVMPD).
• System Integration & Reporting: Enable integration and reporting across regulatory information management systems (RIMS), EDMS, clinical trial systems, and lab data platforms.
• Data Governance & Compliance: Implement data governance, lineage, validation, and audit trails for regulatory data workflows, ensuring GxP and regulatory compliance.
• Automation & Analytics: Guide the development of automation solutions, dashboards, and analytics that improve visibility into submission timelines, data quality, and regulatory KPIs.
• Interoperability: Ensure interoperability between regulatory data platforms and enterprise data lakes or lakehouses for cross-functional reporting and insights.
• Strategic Alignment: Collaborate with IT, data governance, and enterprise architecture teams to ensure alignment with overall data strategy and compliance frameworks.
• Innovation & Emerging Technologies: Drive innovation by evaluating emerging technologies in data engineering, graph data, knowledge management, and AI for regulatory intelligence.
• Team Leadership & Development: Lead, mentor, and coach a small team of data engineers and analysts, fostering a culture of excellence, innovation, and delivery.
• Agile & SAFe Methodologies: Drive Agile and Scaled Agile (SAFe) methodologies, managing sprint backlogs, prioritization, and iterative improvements to enhance team velocity and project delivery.
• Continuous Learning: 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

• Experience: Eight to twelve years of experience in data engineering or data architecture, with over three years in a senior or managerial capacity, preferably within the biotech or pharmaceutical industry.
• Regulatory Support: Proven experience supporting regulatory functions, including submissions, tracking, and reporting for FDA, EMA, and other global authorities.
• Tools & Platforms: Experience with ETL/ELT tools, data pipelines, and cloud-based data platforms (for example, Databricks, AWS, Azure, or GCP).
• Regulatory Standards: Familiarity with regulatory standards and data models such as eCTD, IDMP, HL7, CDISC, and xEVMPD.
• Compliance Expertise: Deep understanding of GxP data compliance, audit requirements, and regulatory submission processes.
• Visualization Tools: Experience with tools like Power BI, Tableau, or Qlik for regulatory dashboarding and visualization is a plus.
• Leadership & Communication: Strong project management, stakeholder communication, and leadership skills, especially in matrixed, cross-functional environments.
• Technical Translation: Ability to translate technical capabilities into regulatory and business outcomes. You'll prepare team members for stakeholder discussions by helping assess data costs, access requirements, dependencies, and availability for business scenarios.

Good-to-Have Skills

• Program Experience: Prior experience working on integrated product teams or regulatory transformation programs.
• System Knowledge: Knowledge of Regulatory Information Management Systems (RIMS), Veeva Vault RIM, or Master Data Management (MDM) in regulated environments.
• Methodology Familiarity: Familiarity with Agile/SAFe methodologies and DevOps/DataOps best practices.

Education and Professional Certifications

• Experience: Twelve to fifteen years of experience in Computer Science, IT, or a related field.
• Certifications:
• Scaled Agile SAFe certification preferred.
• Project Management certifications preferred.

Soft Skills

• Excellent analytical and troubleshooting skills.
• Strong verbal and 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.