Director of AI Enterprise Architecture

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 RoleAbout the RoleMaitsys 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 ResponsibilitiesAI Strategy, Vision & LeadershipDefine 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 OversightArchitect 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 OptimizationEngage 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 SupportConvert 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 IntegrityDesign AI systems that comply with:GMP/GxP21 CFR Part 11EU Annex 11CSV / CSA guidelinesALCOA+ data integrity principlesPartner with validation, QA, security, and compliance teams to ensure proper documentation and controls.Practice Leadership & GrowthBuild 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 Qualifications12–15+ 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 platformsRAG architectures, prompt engineering, vector databasesAWS, Azure, or GCPMLOps, model governance, and monitoringProven 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 QualificationsExperience 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.