Operations Quality Principal Architect

Roche • Poland, OH

7d • PLN 228,900 - PLN 425,100 • Hybrid

About The Position

At Roche Digital Technology (RDT), we are a global community of business-minded technologists dedicated to shaping the future of healthcare through digital innovation. Our mission is to empower Roche with cutting-edge digital technologies, leveraging artificial intelligence, data, and scalable tech innovations. We are building a future where digital is a core strength across Roche, enabling smarter ways of working, unlocking human potential, and driving breakthroughs for patients worldwide. We offer a hybrid work model, requiring employees to be in the office an average of two days per week for collaboration, workshops, and team events.

As an Enterprise AI & Quality Insights Architect, you will play a pivotal role in transforming quality operations globally through artificial intelligence and advanced data platforms. You will lead the architectural design and deployment of NLP, LLM, and agentic workflows within a highly regulated healthcare environment. This role combines strategic product ownership, AI scaling, and matrix leadership to drive digital transformation in quality management.

Requirements

• Strong hands-on engineering proficiency with enterprise data science environments (such as Dataiku or ML Studio).
• Advanced understanding of NLP, LLMs, and prompt engineering architectures.
• Strong proficiency in core programming for data modeling (Python, SQL) and developer workflows (Git, Jira, Confluence, and script automation environments).
• Hands-on experience or deep conceptual understanding of custom agent architectures utilizing tools like the Claude Agent SDK or comparable enterprise-approved development kits.
• Solid structural knowledge of cloud data warehousing (Snowflake), pipeline concepts (AWS), and business intelligence delivery tools (ThoughtSpot, Tableau).
• Bachelor's, Master's, or Ph.D. degree in Data Science, Informatics, Data Analytics, Computer Science, or a related technical field.
• 5-7+ years of experience building and deploying machine learning algorithms, complex data models, or automated software tools to support enterprise-level decision-making.
• Experience working within a highly regulated manufacturing environment (such as Pharma, Diagnostics, or Medical Devices).
• Sound understanding of GxP compliance, US FDA 21 CFR Part 820 Quality Management System Regulations, and ISO 13485/9001 standards.
• Proven capability acting as a principal technical leader, driving global cross-functional projects, and aligning stakeholder expectations with a team-first, agile mindset.

Nice To Haves

• Prior experience with Computerized System Validation (CSV) protocols is highly preferred.

Responsibilities

• Design, scale, and deploy robust machine learning and NLP pipelines utilizing approved enterprise data platforms, primarily focusing on Dataiku and Azure ML Studio layers.
• Evaluate and deploy advanced AI solutions, utilizing the Claude Agent SDK or comparable approved SDKs for complex use cases requiring custom, automated agents to navigate cross-system data silos.
• Architect and mature the global AI Use-Case Backlog, guiding the deployment of NLP and LLMs to automate initial sorting, risk-grading, and real-time categorization of complex quality data.
• Oversee conceptual data modeling and integration pipelines feeding into core analytics repositories (Snowflake and AWS), and partner with builders to translate complex datasets into high-performing enterprise business intelligence views.
• Assume Product Owner and architectural design oversight for core Quality Insight platforms, dashboards, and automation frameworks.
• Establish and champion clean repository management, version control, and collaborative code review practices via Git.
• Drive standardized automation workflows utilizing Jira and Confluence to optimize the subchapter's intake pipeline and eliminate communication latency.
• Ensure all deployed AI models, automated scripts, and data pipelines adhere to computerized system validation protocols under GxP, US FDA (21 CFR Part 820), and ISO 13485 standards.
• Guide the team in authoring, reviewing, and executing technical validation documentation for data integrity.
• Partner directly with Quality Site Heads, Business Leaders, and global cross-functional squads to break down organizational data silos and resolve systemic reporting barriers across site networks.
• Establish, champion, and mentor an Operations Quality Community of Practice for Quality AI & Data Insights.
• Elevate organizational digital fluency by coaching other team members on best practices.

Benefits

• Employment via an external recruitment agency for a period of 18 months
• Compensation Range: 228,900.00 PLN – 425,100.00 PLN gross annually
• Direct exposure to enterprise-scale AI architecture, global cross-functional leadership, and cutting-edge digital health technology in a highly innovative environment.
• Flexible hybrid working model with modern office space in Warsaw.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal