Director of AI Enterprise Architecture

Director, AI Enterprise Architecture (GxP/GMP – Pharma Manufacturing) Location: Boston, MA (Hybrid)
Type: Full-time, Leadership 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.
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.
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:
~ ALCOA+ data integrity principles
~ Partner with validation, QA, security, and compliance teams to ensure proper documentation and controls.

Build and mentor a high-performing AI architecture team within Maitsys.
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.
~ 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.
~ Experience leading cross-functional AI delivery teams.

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).
Influence the AI vision and digital transformation of global pharmaceutical manufacturers.
Lead high-impact, cutting-edge GenAI initiatives.
Opportunity to build Maitsys’s AI architecture practice from the ground up.