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Added 6 mins ago
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Roche

202610-127399 AI/ML Compliance Lead

Mississauga, ON, Canada

Full-time

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Job details

Job type: Full-time
Apply by: Nov 26, 2026
Posting language: English
Posted: Oct 27, 2026

Original job description

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. Driven by our commitment to research and sustainable healthcare solutions, we foster an inclusive, collaborative environment where diverse teams are empowered to question the status quo, drive continuous improvement, and redefine what is possible in modern medicine.

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. If you have a passion for innovation and a proven track record in implementing AI/ML systems, this role is made for you.

Do you bring experience in implementing or enabling the qualifications of digital solutions, preferably in the pharma industry, and are you looking for an impactful role? We seek an individual with excellent knowledge of the pharma data ecosystem, informatics systems, tools, and techniques with a focus on quality and compliance. 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.

The Opportunity

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.

Who you are

You hold a 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.
You possess proven hands-on experience designing, validating, or implementing AI/ML systems in commercial environments, including deep learning, NLP, LLMs, and AI agentic workflows.
You are deeply knowledgeable in FDA/EMA pharmaceutical regulations, GAMP 5, 21 CFR Part 11, Annex 11, and core Quality Risk Management principles (ICH Q9 / ICH Q10).
You bring 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.
You demonstrate strong analytical and problem-solving skills, with the ability to solve complex digital quality issues and manage risk with high autonomy.
You are an exceptional communicator and influencer who can translate complex technical AI/ML compliance concepts to build consensus across cross-functional teams.
You embody Roche’s core mindsets of inclusivity, speaking up, continuous learning, shared accountability, and outcome-focused collaboration.

**This role is not eligible for relocation**

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More about this job

Responsibilities

Lead quality oversight, validation, and compliant implementation of AI/ML systems in regulated GxP and GMP environments, working with data science, software development, IT, and business teams. Develop and review validation documentation, mitigate lifecycle risks, improve CSV/CSA processes, and mentor colleagues in digital compliance and validation.

Requirements

Requires a bachelor’s or master’s degree in a relevant field and 5–7 years of experience in a regulated pharmaceutical, biotech, or medical device environment, including hands-on AI/ML implementation or validation. Candidates should know FDA/EMA regulations, GAMP 5, 21 CFR Part 11, Annex 11, ICH Q9/Q10, programming, cloud platforms, and production MLOps, with strong communication and problem-solving skills.

Skills

AI/ML Compliance
Quality Assurance
Computer System Validation
Computer Software Assurance
GMP
GxP
AI/ML System Validation
Deep Learning
Natural Language Processing
Large Language Models
AI Agentic Workflows
Python
R
Cloud Computing
MLOps
Risk Management

Visa sponsorship

Not detected in the job text

Keywords

Artificial Intelligence
Machine Learning
Digital Quality
Quality Assurance
GMP
GxP
Computer System Validation
Computer Software Assurance
FDA Regulations
EMA Regulations
GAMP 5
21 CFR Part 11
Annex 11
ICH Q9
ICH Q10
Quality Risk Management
Deep Learning
Natural Language Processing
Large Language Models
AI Agentic Workflows
Python
R
AWS
Azure
Google Cloud Platform
MLOps
Model Governance
Model Drift
Dataset Bias
Data Privacy

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