About the Role
At Roche, we believe that every patient deserves access to life-changing innovations. As a global healthcare leader operating across pharmaceuticals and diagnostics, we combine cutting-edge science, advanced technology, and a passion for improving lives to address some of the world's most challenging medical needs.
We are seeking an experienced AI/ML & Digital Quality Lead to provide Quality Assurance oversight and guidance while designing and implementing cutting-edge AI/ML Digital solutions in a GMP Environment. As the AI/ML Compliance Lead you will work with the business, data scientists, and IT to design, validate, implement and support in operation Artificial Intelligence and Machine Learning (AI/ML) Systems to fulfill GMP business objectives. By working closely with technical teams, you will ensure AI/ML solutions are accurate, efficient, scalable, secure, and validated for GMP use.
Responsibilities
•Lead the Quality Assurance oversight, validation, and compliant execution of cutting-edge AI/ML systems within a regulated GxP and GMP business environment.
•Collaborate cross-functionally with data science, software development, and IT teams to integrate AI/ML algorithms into business applications under a standard Computer System Validation (CSV) and Computer Software Assurance (CSA) framework.
•Author, review, and approve critical validation documentation, including validation plans, technical specifications, system architecture diagrams, and test scripts.
•Identify and proactively mitigate quality, security, and data privacy risks across the full AI/ML lifecycle, addressing issues such as model drift, dataset bias, and validation boundaries.
•Influence and align diverse technical and operational stakeholders across global business units to establish compliant validation strategies for advanced digital solutions.
•Drive continuous improvement initiatives that streamline CSV/CSA processes, integrating emerging AI risk management frameworks into existing quality management systems.
•Mentor and coach colleagues across Digital Compliance and broader Quality functions, fostering an agile mindset and supporting capability building in digital validation.
Requirements
•BS/MS degree in Science, Computer Science, Engineering, or a related field, backed by 5-7 years of relevant experience in a regulated pharmaceutical, biotech, or medical device environment.
•Proven hands-on experience designing, validating, or implementing AI/ML systems in commercial environments, including deep learning, NLP, LLMs, and AI agentic workflows.
•Deep knowledge of FDA/EMA pharmaceutical regulations, GAMP 5, 21 CFR Part 11, Annex 11, and core Quality Risk Management principles (ICH Q9 / ICH Q10).
•Functional expertise in programming languages (e.g., Python, R) along with cloud computing platforms (AWS, Azure, GCP) and MLOps practices for model governance in production.
•Strong analytical and problem-solving skills, with the ability to solve complex digital quality issues and manage risk with high autonomy.
•Exceptional communication and influencing skills, able to translate complex technical AI/ML compliance concepts to build consensus across cross-functional teams.
Notes
•This role is not eligible for relocation.
•Artificial intelligence is used to screen, assess or select applicants for this role.
•This posting is for an existing vacancy at Hoffmann-La Roche Ltd.
About Roche
More than 100,000 employees across the globe are dedicated to advancing science, ensuring everyone has access to healthcare today and for generations to come. Roche's efforts have resulted in more than 26 million people treated with their medicines and over 30 billion tests conducted using their Diagnostics products.
