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Added 13 mins ago
BH
Full Stack Developer
Berkshire Hathaway Group Reinsurance Division
Toronto, ON
- Full-time
· Proficiency in modern software development practices using AI-assisted coding platforms, including GitHub Copilot, to accelerate development, improve code quality, and enhance…
Added 13 mins ago
Director, Client Enablement
Questrade Financial Group
Toronto, ON
Have a Bachelor's degree in Business, Operations, Information Technology, Engineering, or a related discipline, or equivalent practical experience.
Added 13 mins ago
Q
Customer Success Operations Analyst
Quadient
Markham, ON
- $52,000 to $75,000 CAD / year
- Full-time
Process engineering: Map, document and optimize Customer Success processes from sales handoff through onboarding, renewal and expansion. Identify gaps, remove manual effort and build…
Added 13 mins ago
R
GitHub Enterprise & DevOps Administrator
Raise
Burnaby, BC
- Full-time
The GitHub Enterprise & DevOps Administrator to join the IT Infrastructure and DevOps Engineering team. In this role, you will collaborate closely with ’s Lead GitHub Administrator and the…
Added 13 mins ago
R
Senior DevSecOps and Application Security SME
Raise
Vancouver, BC
- Full-time
Incident Response Support: Provide support during and after critical system breaches, outages, or anomalies by drafting security operations documents (e.g., incident reports) and…
Added 28 mins ago
IT Applications Support Analyst
Hilton Food Group Plc
Brantford, ON
Collaborate with production, engineering, and quality teams to understand system requirements and translate them into technical solutions.
Added 28 mins ago
C
Agentic AI Developer
CGI
Ottawa, ON
- Full-time
Strong software engineering and problem-solving abilities, effective communication, ability to work independently and collaboratively, adaptability to emerging AI technologies, and a…
Added 58 mins ago
Y
Recruiter - Technical and Sales (B2B)
YuJa
Toronto, ON · North York, ON
- $50,000 to $55,000 CAD / year
- Full-time
…delivering engaging, secure, and accessible digital experiences. Our platforms such as Lumina (video), Panorama (LMS accessibility), EqualGround (governance), and Verity (proctoring) are…
Added 58 mins ago
GM
Senior Quality Assurance Specialist
Galactic Minds INC
Toronto, ON
- Contract
● Performance Engineering: Identify bottlenecks in the data product lifecycle. Analyze how the system behaves under high load and work with developers to optimize performance.
Added 58 mins ago
T
Network Designer/Architect
TEEMA
Toronto, ON
- Contract
…multiple Agency products and services in the context of Provincial system integrations and overall Provincial strategic…
Added 58 mins ago
T
Director Enterprise Applications, Data
TEEMA
Vancouver, BC
- $160,000 to $215,000 CAD / year
- Full-time
Director, Application, Data & Integration | Dynamics 365 · AI-Assisted Engineering (Claude Code) ·
Added 58 mins ago
M
Senior Advisor Analytics
Manpower
Calgary, AB
- Contract
Proven experience analyzing operational and near-real-time data (e.g., AVEVA PI System, SCADA-derived data, or similar operational platforms).
Added 1 hour ago
Senior Manager, Data Science & Service Intelligence
Questrade Financial Group
Toronto, ON
…across Genesys Cloud, Salesforce, Google BigQuery, and internal platforms, breaking down operational silos in collaboration with central Data and Technology…
Added 1 hour ago
A
Instrumentation & Monitoring Data Review Engineer
Arcadis
Vancouver, BC
- Full-time
Arcadis is the world's leading company delivering sustainable design, engineering, and consultancy solutions for natural and built assets.
Added 1 hour ago
CI
Associate, Investment Engineering & Analytics (12-month contract)
CPP Investments | Investissements RPC
Toronto, ON
- Full-time
As part of the Total Portfolio Investment Platforms team, you will collaborate across investment engineering and business teams to deliver end-to-end solutions, from data ingestion to…
Added 1 hour ago
S
Senior Network Designer
StafinGo
Toronto, ON
- $90 to $110 CAD / hour
- Contract
…multiple Agency products and services in the context of Provincial system integrations and overall Provincial strategic…
Added 1 hour ago
AI
Full Stack Developer
Alberta iGaming Corporation (AiGC)
AB · Edmonton, AB
- Full-time
…Alberta's regulated iGaming market. Reporting to the Manager, Data Platforms, this position is responsible for end-to-end application development, from requirements gathering and solution…
Added 1 hour ago
IC
Business & Systems Consultant
Infotek Consulting Inc.
Toronto, ON
- $60 to $65 CAD / hour
- Contract
Strong understanding of business and technology platforms, digital solutions, and system transformation initiatives.
Added 1 hour ago
GM
Business Operations & Product Development Manager
Global Medical Products Inc.
Burlington, ON
- Full-time
Use our ERP system (Odoo) to monitor transactions, maintain operational visibility, troubleshoot issues, and support informed decision-making.
Added 1 hour ago
RL
Meter Programming and Test Data Technician - Day shift
Romet Limited
ON · Mississauga, ON
- Full-time
…customers' needs now and 20 years from now. Our technological platforms are designed to seamlessly provide customer-centric measurement solutions. Our mission is centered on customer…
Added 1 hour ago
R
AI/ML Compliance Lead
Roche
Mississauga, ON · Canada Pharma Campus
- Full-time
…algorithms into business applications under a standard Computer System Validation (CSV) and Computer Software Assurance (CSA)…
Added 1 hour ago
C
Java Developer Lead Analyst - Vice President
Citi
Mississauga, ON
- Full-time
Evaluate complex business and system processes to resolve high-impact technical challenges, developing innovative and pragmatic engineering solutions.
Added 1 hour ago
B
Lead Cloud Software Developer - (AWS / AI / Real Time Payment Systems)
BMO
Toronto, ON · BMOPLACE
- Full-time
…managing the preparation of design specifications. Supports system design, provides advice on security requirements and debugs business systems and service applications. Applies deep…
Added 1 hour ago
JE
Quality Assurance Manager
Johnson Electric
Stratford, ON · Canada - PM Stratford (General)
- Full-time
Maintain and continuously improve the Quality Management System in accordance with IATF 16949 and customer-specific requirements
Added 1 hour ago
R
202610-127399 AI/ML Compliance Lead
Roche
Mississauga, ON
- Full-time
…algorithms into business applications under a standard Computer System Validation (CSV) and Computer Software Assurance (CSA)…

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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