Director of AI Enterprise Architecture
hace 2 días
Boston
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., • 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., • 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., • 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., • Design AI systems that comply with:, • GMP/GxP, • 21 CFR Part 11, • EU Annex 11, • CSV / CSA guidelines, • ALCOA+ data integrity principles, • 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., • 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 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., • 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.