AI/ML Compliance Lead

Description

The company works across pharmaceuticals and diagnostics, pairing science and technology to tackle hard medical problems. It employs more than 100,000 people, its medicines have treated over 26 million patients, and its diagnostic products have run over 30 billion tests.

This is an existing vacancy. You will oversee quality assurance for AI/ML digital solutions while helping design and build them in a GMP setting.

You will work with the business, data scientists and IT to validate, implement and maintain AI/ML systems that serve GMP goals and are accurate, efficient, scalable, secure and validated for GMP use. The role suits someone with pharma data and informatics knowledge who focuses on quality and compliance.

Responsibilities

• Lead quality assurance oversight, validation and compliant execution of AI/ML systems in regulated GxP and GMP environments.
• Work with data science, software development and IT to fit AI/ML algorithms into business applications under a standard CSV and CSA framework.
• Write, review and approve validation documents, including validation plans, technical specifications, system architecture diagrams and test scripts.
• Find and reduce 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 for advanced digital solutions.
• Lead improvement work that streamlines CSV and CSA processes and brings emerging AI risk management frameworks into existing quality systems.
• Mentor colleagues in Digital Compliance and the wider Quality function, building an agile mindset and digital validation capability.

Requirements

• A BS or MS degree in science, computer science, engineering or a related field, plus 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 settings, including deep learning, NLP, LLMs and AI agentic workflows.
• Deep knowledge of FDA and EMA pharmaceutical regulations, GAMP 5, 21 CFR Part 11, Annex 11, and ICH Q9 and ICH Q10 quality risk management.
• Functional skill in programming languages such as Python or R, cloud platforms (AWS, Azure, GCP), and MLOps practices for model governance in production.
• Strong analytical and problem-solving skills to resolve complex digital quality issues and manage risk with high autonomy.
• Excellent communication and influence, translating complex AI/ML compliance concepts to build consensus across cross-functional teams.
• Alignment with the company's core mindsets: inclusivity, speaking up, continuous learning, shared accountability and outcome-focused collaboration.

Conditions

Based in Mississauga, with a expected salary range of 115,328.00 to 151,368.00. Actual pay depends on experience, qualifications and other job-related factors set by the company.

This role is not eligible for relocation.

The company uses artificial intelligence to screen, assess or select applicants for this role.

The company is an equal opportunity employer.