Quality Governance Lead

Roche; Mississauga; On-site; CAD 120,000 - 180,000; Full time

Job summary

Roche is seeking an experienced AI/ML & Digital Quality Lead to oversee Quality Assurance while designing and implementing AI/ML digital solutions in a GMP environment in Mississauga, Canada.

The role focuses on validation, documenting critical specifications, and ensuring AI/ML systems meet regulatory requirements across global teams. Strong collaboration and communication are essential.

Qualifications

• BS/MS in Science/CS/Engineering or related field with 5–7 years in regulated pharma/biotech/medical devices.
• Hands-on experience designing/validating AI/ML systems in commercial environments.
• Knowledge of FDA/EMA regulations, GAMP 5, 21 CFR Part 11, Annex 11, and core Quality Risk Management (ICH Q9/Q10).

Responsibilities

• Lead QA oversight, validation, and compliant execution of AI/ML systems in a regulated GMP environment.
• Collaborate with data science, software, and IT to integrate AI/ML into business applications under CSV/CSA.
• Author, review, and approve validation documentation (plans, specs, architecture, test scripts).
• Identify and mitigate quality, security, and data privacy risks across AI/ML lifecycle.
• Address model drift, dataset bias, and boundary validation in production systems.
• Influence stakeholders across global units for compliant validation strategies.
• Drive continuous improvement integrating AI risk management into the quality system.

Skills

AI/ML systems

Deep learning

NLP

LLMs

Python

R

AWS

Azure

GCP

MLOps

Communication

Risk management

Education

BS/MS in Science/CS/Engineering or related field

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**