Enterprise Architect - Life Sciences

Role Overview

The Enterprise Architect (EA) specializing in Life Sciences is tasked with establishing and overseeing the enterprise-wide architectural framework in harmony with corporate strategy, scientific procedures, and regulatory mandates. This role assures the creation of scalable and compliant architecture facilitating interoperability among R&D, Clinical, Manufacturing, Quality, Regulatory, and Commercial functions.

Core Responsibilities

• Define and sustain a comprehensive enterprise architecture vision encompassing principles, standards, and strategic roadmaps aligned with life sciences objectives.
• Develop current and target state frameworks across business, application, data, and technology domains.
• Lead architecture for digital initiatives involving cloud adoption, AI/ML integration, data platforms, and modernization of legacy systems.
• Align architectural efforts with organizational strategies across all key life sciences domains including research, clinical, manufacturing, and quality.
• Architect solutions that enable seamless data flow, adherence to FAIR data principles, data interoperability, and integration of commercial off-the-shelf platforms with enterprise systems.
• Define data architectures compatible with diverse data types including structured, semi-structured, and unstructured datasets, support cloud and hybrid environments, and design integration via APIs and event-based systems.
• Ensure compliance with GxP, 21 CFR Part 11, GDPR, HIPAA, and incorporate security and auditability into architectural designs.
• Engage actively in Architecture Review Boards and governance structures to mitigate risks and endorse best practices.
• Collaborate with business and IT leaders to translate strategic goals into practical architecture and provide expert guidance on technology and risk.
• Mentor solution architects and technical teams, advocate reuse of platforms and standards, and contribute to enhanced enterprise architecture maturity.

Required Qualifications and Expertise

• Proficiency with Enterprise Architecture frameworks such as TOGAF or similar.
• Hands-on experience across application architectures including monoliths and microservices.
• Deep knowledge of data architectures including data warehouses, lakes, and master data management.
• Expertise in integration architectures using APIs, ESB, event-driven methods.
• Comprehensive experience with cloud architectures on AWS, Azure, or GCP platforms.
• Background in modernizing legacy life sciences information systems.
• Minimum 4 to 6 years working in Life Sciences, Pharma, or Healthcare IT sectors with exposure to regulated environments (GxP).
• Familiarity with life sciences platforms such as LIMS, ELN, CTMS, EDC, eTMF, Safety, MES, and QMS.
• Experience utilizing architecture tools like Sparx EA, LeanIX, or ArchiMate and data analytics platforms.
• Excellent interpersonal and communication skills with the ability to influence diverse stakeholders including senior management.