Senior Manager, Full Stack Software Engineering & Operations Regulatory BI&T

Position Summary We are seeking a Senior Manager, Full Stack Software Engineer, to serve as a technical leader in an agile product environment supporting Global Regulatory Sciences (GRS) technologies. This role is accountable for the end-to-end build and run of AI-native technology assets supporting Global Regulatory Sciences, ensuring solutions are reliable, accessible, secure, compliant, and cost-effective. The Senior Manager designs, builds, and operates AI native products where large language models, agentic workflows, and data-driven intelligence are the default paradigm-not an addon. The role blends hands‑on full stack engineering, AI product thinking, and operational ownership, with responsibility for both delivery and the long‑term sustainability of platforms in a regulated BioPharma environment. This position provides cross‑product technical leadership without direct line management, influencing architecture, shared capabilities, vendor direction, and long‑term technical strategy through expertise, collaboration, and hands‑on contribution. Key Responsibilities AI Native Product & Platform Ownership: Own the build, operation, and continuous improvement of AI native Regulatory applications and platforms, including bespoke solutions and AI-enabled SaaS. Ensure Regulatory technology assets are stable, secure, compliant, and operationally sound across their lifecycle. Remain sufficiently hands‑on to design, build, review, and troubleshoot critical components. Technical Strategy, Architecture & Roadmap: Develop and maintain an AI‑first Regulatory technology roadmap, guiding build vs. buy decisions, model selection, and platform capabilities aligned to business outcomes. Define and enforce reference architectures, reusable patterns, and technical guardrails to ensure consistency and quality across products. Evaluate emerging technologies and delivery models (SaaS / PaaS / IaaS) and influence vendor roadmaps and negotiations to align with enterprise strategy. Engineering Execution & Operations: Design, develop, and operate scalable, secure full stack solutions using Python, Java / Node.js, React, REST APIs, and modern cloud‑native architectures. Design and operate Large Language Models (LLM) native and agentic systems as long‑lived products, incorporating human‑in‑the‑loop, monitoring, governance, and continuous improvement. Build and maintain ML and data pipelines for training, validation, deployment, monitoring, retraining, and rollback. Implement CI/CD practices and automate workflows across data ingestion, feature engineering, model versioning, and deployment. Diagnose and resolve complex technical issues, balancing short‑term remediation with long‑term architectural strategy. Product, Stakeholder & Vendor Partnership: Partner closely with IT Product Managers and GRS stakeholders to plan, prioritize, deliver, and support strategic digital capabilities. Translate business needs into well designed technical solutions that drive measurable impact in regulatory and operational workflows. Operate effectively in a highly matrixed organization, aligning stakeholders with differing priorities. Financial & Operational Stewardship: Manage and optimize Total Cost of Ownership (build and run) for technology assets, understanding and influencing key cost drivers. Ensure solutions are cost efficient, scalable, and sustainable over time. Required Qualifications & Experience 6+ years of software engineering experience; BioPharma / Life Sciences experience strongly preferred. Bachelor’s degree in Computer Science, Software Engineering, Engineering, Life Sciences, or a related quantitative field; advanced degree preferred. Proven track record delivering complex, production‑grade solutions using structured SDLC and Agile product models in regulated environments. Hands‑on experience with developing software and applications that use Large Language Models (LLM) and hands‑on AI coding with tools such as Codex, Claude Code, OpenAI, etc. Hands‑on experience building Generative and Agentic AI systems using frameworks such as LangChain, LlamaIndex, and enterprise LLM platforms (e.g., OpenAI, AWS Bedrock). Strong proficiency in Python and React; familiarity with Java, TypeScript, and backend frameworks such as FastAPI. Experience with AWS cloud services (Lambda, S3, DynamoDB, Bedrock, SageMaker) and event‑driven, microservices‑based architectures. Knowledge of Github and source control version management. Strong data engineering and analytics skills (SQL / NoSQL). Experience working with vendor partners and offshore development models. Experience in Regulatory Affairs technologies such as Veeva RIM, Lorenz DocuBridge, Health Authorities Queries (HAQ), or Labeling preferred. Core Competencies Strong technical judgment with the ability to link architecture decisions to business outcomes. Excellent communication skills across engineering, product, business, and executive audiences. Ability to execute multiple large initiatives concurrently in an Agile, product‑centric model. Collaborative, pragmatic, and comfortable operating in ambiguity and change. Innovative mindset with the discipline to deliver reliable, compliant, enterprise‑grade solutions. Compensation Madison - Giralda - NJ: $135,320 - $163,976 Princeton - NJ: $135,320 - $163,976 Additional incentive cash and stock opportunities (based on eligibility) may be available. #J-18808-Ljbffr Jerseydigs