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Director of AI Enterprise Architecture
Director of AI Enterprise ArchitectureMaitsys • Boston, MA, United States
Director of AI Enterprise Architecture

Director of AI Enterprise Architecture

Maitsys • Boston, MA, United States
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  • [job_card.full_time]
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Job Description : Director, AI Enterprise Architecture (GxP / GMP – Pharma Manufacturing)

Location : Boston, MA (Hybrid)

Company : Maitsys Inc.

Experience : 10+ years (12–15+ preferred)

Type : Full-time, Leadership Role

About the Role

Maitsys Inc. is seeking a visionary Director of AI Enterprise Architecture to lead the design, strategy, and implementation of next-generation AI solutions for our pharmaceutical and biotech manufacturing clients. This senior leader will define enterprise-wide AI architecture, drive GxP / GMP-compliant AI innovation, and serve as a trusted advisor to client executives and business leaders.

The Director will play a central role in shaping Maitsys’s AI strategy and will directly influence how our clients adopt GenAI, agentic AI, intelligent automation, and data-driven decision systems—ensuring alignment with regulated industry standards and business outcomes.

This position requires a unique mix of strategic leadership, architectural depth, GxP domain expertise, and strong client-facing consulting ability.

Key Responsibilities

AI Strategy, Vision & Leadership

  • Define and lead the overall AI enterprise architecture vision for Maitsys and its clients.
  • Develop multi-year AI roadmaps, strategic frameworks, and adoption models for pharma manufacturing organizations.
  • Lead executive-level AI discussions, articulating business value, risk management, and transformation opportunities.
  • Drive responsible, ethical, and secure AI adoption aligned to regulatory compliance.

Enterprise Architecture & Technical Oversight

  • Architect end-to-end solutions leveraging GenAI, agentic AI, LLM platforms, RAG systems, vector databases, MLOps, and cloud services.
  • Build and maintain AI architecture standards, blueprints, design patterns, and reusable frameworks.
  • Direct solution architecture reviews and ensure systems meet GxP / GMP, data integrity (ALCOA+), 21 CFR Part 11, and Annex 11 requirements.
  • Oversee complex AI platform integrations across MES, QMS, LIMS, ELN, SCADA, ERP and manufacturing data systems.

    • Business Advisory & Process Optimization

  • Engage with business stakeholders—manufacturing, QA / QC, supply chain, labs—to identify high-impact AI transformation opportunities.
  • Translate business processes into AI-enabled workflows and automation strategies.
  • Facilitate workshops and design sessions to accelerate clients’ AI readiness and workforce enablement.
  • Serve as a thought partner for C-level and VP-level decision makers.

    • Technical Translation & Delivery Support

  • Convert business needs into detailed technical requirements for AI engineers, data engineers, and ML teams.
  • Provide leadership throughout model ideation, development, testing, validation, and deployment.
  • Ensure models follow best practices for performance, reliability, explainability, and compliance.
  • Oversee implementation of AI agents, copilots, knowledge assistants, and domain-specific automation solutions.

    • Compliance, Governance & Data Integrity

  • Design AI systems that comply with :
  • GMP / GxP
  • 21 CFR Part 11
  • EU Annex 11
  • CSV / CSA guidelines
  • ALCOA+ data integrity principles
  • Partner with validation, QA, security, and compliance teams to ensure proper documentation and controls.

    • Practice Leadership & Growth

  • Build and mentor a high-performing AI architecture team within Maitsys.
  • Contribute to thought leadership, playbooks, accelerators, and delivery methodologies.
  • Support pre-sales, proposals, SOW creation, and client advisory engagements.
  • Represent Maitsys at conferences, industry events, and client innovation forums.

    • Required Qualifications

  • 12–15+ years of experience in Pharma, Biotech, Life Sciences, or regulated manufacturing.
  • Extensive background in GxP / GMP, CSV / CSA, quality systems, and compliance frameworks.
  • Deep expertise in enterprise architecture for AI / ML, GenAI, agentic systems, and cloud environments.
  • Hands-on experience with :
  • OpenAI, Azure OpenAI, Anthropic, or similar LLM platforms
  • RAG architectures, prompt engineering, vector databases
  • AWS, Azure, or GCP
  • MLOps, model governance, and monitoring
  • Proven ability to lead client-facing architecture discussions and influence senior executives.
  • Strong communication and storytelling skills with both technical and non-technical audiences.
  • Experience leading cross-functional AI delivery teams.

    • Preferred Qualifications

  • Experience with GAMP 5, AI validation frameworks, and regulated system integration.
  • Familiarity with MES (Werum / Siemens), LIMS (LabWare / STARLIMS), QMS (TrackWise / Veeva), or manufacturing data lakes.
  • Prior leadership role in consulting, digital transformation, or enterprise architecture.
  • MBA, M.S. in AI / ML / Data Science, or TOGAF certification is a plus (not required).

    • Why Join Maitsys?

  • Influence the AI vision and digital transformation of global pharmaceutical manufacturers.
  • Lead high-impact, cutting-edge GenAI initiatives.
  • Work with a rapidly growing team in a leadership role.
  • Opportunity to build Maitsys’s AI architecture practice from the ground up.
  • Collaborative culture with strong executive support.
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