AI/ML Compliance Lead

Roche

. Lead Quality Assurance oversight, validation, and compliant execution of AI/ML systems in regulated GxP and GMP environments .

Posted 10/27/2026full-timeMississauga • CanadaSenior💰 CA$115,328 - CA$151,368 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Assurance oversight and validation of AI/ML systems within regulated GxP and GMP environments, with a strong focus on compliance and risk management. Proficient in collaborating across teams to integrate AI/ML algorithms while driving continuous improvement in validation processes.

Highest-signal resume keywords

Quality Assurance OversightAI/ML System ValidationRegulatory Compliance (FDA/EMA)Python or R ProgrammingMLOps Practices

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

AI/ML System DesignDeep LearningNatural Language Processing (NLP)Large Language Models (LLMs)Validation Plans AuthoringTechnical Specifications ReviewTest Scripts DevelopmentRisk ManagementData PrivacyModel Governance

Soft Skills

Analytical SkillsProblem-SolvingCommunicationInfluencingMentoring

Tools & Technologies

AWSAzureGoogle Cloud Platform (GCP)CSV FrameworkCSA Framework

Industry Keywords

GxPGMPPharmaceutical RegulationsGAMP 521 CFR Part 11Annex 11ICH Q9ICH Q10Commercial EnvironmentsDigital Compliance

Tech Stack

Tools & technologies

AWSAzureGoogle Cloud PlatformPython

About the role

Key responsibilities & impact

Lead Quality Assurance oversight, validation, and compliant execution of AI/ML systems in regulated GxP and GMP environments
Collaborate with data science, software development, and IT teams to integrate AI/ML algorithms into business applications under CSV and CSA frameworks
Author, review, and approve validation plans, technical specifications, system architecture diagrams, and test scripts
Identify and mitigate quality, security, and data privacy risks across the AI/ML lifecycle, including model drift, dataset bias, and validation boundaries
Align technical and operational stakeholders across global business units on compliant validation strategies
Drive continuous improvement of CSV/CSA processes and integrate emerging AI risk-management frameworks into quality management systems
Mentor and coach colleagues across Digital Compliance and Quality functions

Requirements

What you’ll need

BS/MS degree in Science, Computer Science, Engineering, or a related field
5–7 years of relevant experience in a regulated pharmaceutical, biotech, or medical device environment
Hands-on experience designing, validating, or implementing AI/ML systems in commercial environments
Experience with deep learning, NLP, LLMs, and AI agentic workflows
Knowledge of FDA/EMA pharmaceutical regulations, GAMP 5, 21 CFR Part 11, Annex 11, and ICH Q9/ICH Q10
Functional expertise in Python or R
Experience with AWS, Azure, or GCP
Knowledge of MLOps practices for production model governance
Strong analytical, problem-solving, communication, influencing, and risk-management skills
Ability to work cross-functionally with business, data science, software development, IT, and Quality teams

Benefits

Comp & perks

Inclusive workplace culture
Opportunities for personal and professional growth
Continuous learning and capability-building support
Mentorship and coaching opportunities
Equal opportunity employer