Architecture & Design:
Architect & design solutions to accelerate drug development through digitalization of the biosample processes and provisioning of actionable data products.
Define and evolve the end-to-end technical architecture and data model for the Biosample Management product, ensuring scalability, reliability, security, and performance taking into account organizational constraints.
Translate business requirements and user stories related to biosample workflows and data flows into robust and practical technical designs.
Evaluate and select appropriate technology stacks, cloud services, and integration patterns (e.g., APIs, message queues) for various product components in accordance with enterprise guidance.
Create and maintain architectural documentation, including system diagrams, data flow models, and technical specifications.
Ensure the architecture adheres to relevant regulatory standards (e.g., GxP, FDA 21 CFR Part 11) and industry best practices.
Technical Leadership & Collaboration:
Act as the primary technical point of contact for the product Core Team, engineering team, Vendors, other products’ stakeholders, and external stakeholders.
Collaborate closely with Product Management to define the technical roadmap and technical debt strategy. Strong focus on business outcomes.
Develop architecture knowledge by participating in:
Relevant product ceremonies
Architecture governance bodies
Domain Architecture Community
Product & Technology related events
Work with Validation and DevOps teams to ensure testability, automation, and operational readiness of the platform.
Conduct architectural reviews and technical design evolutions and approvals.
AI Architecture and Governance:
Design and govern AI for biosample data products, ensuring reproducibility, versioning of models, and traceability of data.
Define the technical strategy for integrating Large Language Models (LLMs) and Generative AI components responsibly within the Biosample Management product ecosystem.
Ensure compliance with internal AI governance frameworks, data privacy regulations (e.g., GDPR, FDA, HIPAA-related principles), and ethical guidelines for all AI-driven features.
Customer & Stakeholder Engagement:
Engage with potential and existing customers (e.g., lab scientists, biobank managers, IT personnel) to understand their biosample management challenges and gather technical and non-functional requirements.
Assist in troubleshooting complex technical issues that require deep system knowledge.
Work closely with enterprise architects in the domain to architect the solutions according to the enterprise standards.
Work closely with other solution architects in the domain to architect the solutions which co-exist and fit in the domain’s ecosystem.
Key Deliverables:
Solution Outline and End-to-End Design (SAD)
Architecture inputs for System Risk Assessment (SRA/DCR)
Data Architecture and Integration Design
As-Is and Target Landscapes with Roadmaps (Lifecycle maps, architectural assessments & recommendations)
Define and design for NFRs and fitness functions
Record and publish Architectural Decision Records (ADRs)
DRP procedures (recovery)
SDD - Security Design Documents
Input to Vendor Risk Assessment (VRA)
Design Specification, Non Functional Requirements
Development Cycle Specification (GIT)
Code review/Code quality standards and procedures

Solution Architect

💰 Wynagrodzenie

📋 Informacje

🛠 Wymagane technologie

📝 Twój zakres obowiązków

📡 Metadata statystyk

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