AI/ML & Digital Quality & Compliance Lead

7 months ago

Mississauga, Canada Roche Full time

The Position

Title:  AI/ML & Digital Quality & Compliance Lead (Compliance Lead)

Department: Quality, Pharma Technical Operations

Duration: Regular Full-Time Role

Type: Individual Contributor Role

Primary Location: Mississauga

Secondary Locations: San Francisco, Basel, Indianapolis

Number of Positions:  1


Who We Are

At Roche, we strive to deliver 3-5x more benefits to our patients at half the cost to society as part of our 2030 Pharma vision.

As the recently formed global Computer Systems Quality Assurance (CSQA) chapter within the Pharma Technical Operations (PT) Quality organization, we enable the delivery of regulatory-compliant digital solutions with our customers to bring actionable insights and leadership for compliant outcomes for Pharma Technical Operations (PT). Key accountabilities include: 

Enabling delivery of compliant digital systems

Ownership of the Global GMP Inventory of Computerized Systems

Global Computer System Validation Oversight and CSA Oversight within Pharma Technical 

Engaging with Local/Site Validation SMEs and Leaders

In CSQA , we partner across major global business functions – PTQ, PT Digital & Operational Excellence (PTE), PT-Development, PT-Regulatory, and PT-Manufacturing, and our partners in Global Informatics. Together, we will build a solid cross-functional and inclusive community, put the power of data into the hands of our people, further develop Lean and Digital skills across PT, and scale up our Digital and Advanced Analytics solutions for the benefit of our colleagues and patients.

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.


What We Are Looking For

We are looking for an experienced AI/ML & Digital Quality Lead to provide Quality Assurance 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.

As the AI/ML Systems Quality Lead, you will work with the business, data scientists, and IT to design and implement an Artificial Intelligence and Machine Learning (AI/ML) Systems Governance Framework to support GMP business objectives. You will work closely with the software development and data science teams to design, build, and implement AI/ML models that are accurate, efficient, scalable, secure, and validated for GMP use.

Your Accountabilities:

You work closely with stakeholders to identify business needs and requirements and propose technical solutions leveraging AI/ML technologies.

Develop and maintain a comprehensive understanding of the organization's technical landscape, data infrastructure, and data processing pipelines.

Lead the design and implementation of AI/ML systems that are accurate, efficient, scalable, and secure.

Work with the data science team to identify the appropriate algorithms and models for specific business problems and implement them in production systems.

Work with the software development team to integrate AI/ML systems with existing business applications and data systems.

Develop and maintain documentation for AI/ML systems, including technical specifications, system architecture diagrams, and user guides.

Ensure that AI/ML systems comply with relevant regulatory requirements, such as data privacy laws and industry standards.

Keep current with emerging AI/ML and advanced digital technologies, and assess their potential impact on the organization's technical landscape.

The Mindsets we're looking for:

The successful candidate will have — and be passionate about encouraging others to adopt: 

A mindset of inclusivity

A mindset of speaking-up

A mindset of coaching others

A mindset of focusing on outcomes

A mindset of continuous learning

A mindset of shared accountability


Who You Are:

BS/MS degree or equivalent in Science or Engineering Field, with years of experience in a regulated industry, such as the pharma/biotech or medical device industry, commensurate with grade level

4+ years of relevant work experience OR

An equivalent mix of education and work experience is required

Experience in designing and/or implementing AI/ML/Adavanced Digital Analytic systems in a commercial environment.

Strong knowledge of AI/ML technologies, including deep learning, natural language processing, and computer vision.

Knowledge of Pharmaceutical Regulations (FDA/EMA) and how they relate to computerized systems (Part 11/Annex 11 Computer Systems Validation)

Strong knowledge of programming languages such as Python, R, Julia, etc..

Strong knowledge of data processing and storage technologies such as Hadoop, Spark, and NoSQL databases.

Experience with cloud computing platforms such as AWS, Azure, or Google Cloud Platform.

ML Ops experience: model tracking and governance, multiple models in different production contexts, etc.

Excellent problem-solving and analytical skills, with the ability to identify and solve complex technical problems.

Excellent communication and collaboration skills, with the ability to work effectively with stakeholders across the organization.

Strong leadership skills, with the ability to lead a team of technical professionals.

Diverse technical experience, including AI model development, software engineering, regulated software quality and risk management, and monitoring of deployed software.

Experience with data modeling and data exploration tools, including expertise in the use of scientific computing and data management packages, is required.

A demonstrated ability to provide vision and guidance at an institutional or enterprise level.

Exceptional human relations and communication (written, verbal, and listening) skills will be necessary to communicate across disciplines and stakeholders effectively.

Understand working in a compliance-based and regulated environment, including building, deploying, and supporting secure software throughout the AI development life cycle.

Experience with quality systems regulation is required—additional experience with applicable ISO standards is desired.

*This role is not eligible for relocation*

  • Global Reconciliation Ai/ml Development Lead

    6 months ago

    Mississauga, Canada Citi Full time

    **The Olympus Data Reconciliation and Engineering team is responsible for delivering enterprise solutions and **common operating model, that provides scalable, efficient and standardize processing for complex reconciliations in the global processing hubs.** **This role, **Global Reconciliation AI/ML Development Lead, **will be responsible for all aspects of...

  • Senior Digital Solutions Expert

    2 days ago

    Mississauga, Ontario, Canada Bell Canada Full time

    As a Senior Digital Solutions Expert at Bell Canada, you will have the opportunity to work on designing and maintaining customer-centric conversational experiences that meet the evolving needs of our customers. With a strong focus on Artificial Intelligence (AI) and Machine Learning (ML), you will be part of a dynamic team that is shaping the future of...

  • AI Solutions Deployment Manager

    4 weeks ago

    Mississauga, Ontario, Canada SOTI Full time

    Job DescriptionWe are seeking an experienced AI Solutions Deployment Manager to lead the integration and deployment of cutting-edge AI solutions into our flagship products.About SOTISOTI is a leading provider of mobility management and security solutions. We have demonstrated commitment to staying at the forefront of mobility management and security, with a...

  • Customs Compliance Analyst

    6 months ago

    Mississauga, Canada Kuehne+Nagel Full time

    Would you like to launch your career with one of the most successful logistics organizations worldwide? Here at Kuehne+Nagel, our Mississauga branch is looking for a new Compliance Analyst to join our Customs team. ** Your Responsibilities**: - Reviewing and updating of HS classification codes to client databases - Tariff opinions / preparing requests for...

  • AI Technical Lead for Biomarker Data Integration

    2 weeks ago

    Mississauga, Ontario, Canada F. Hoffmann-La Roche Gruppe Full time

    Company OverviewF. Hoffmann-La Roche Gruppe is a leading research-focused healthcare group with over 100,000 people across 100 countries. We are committed to pushing back the frontiers of healthcare through innovation and diversity.The Roche Pharma Canada office in Mississauga, Ontario, employs over 850 employees and embodies our innovative culture.We...

  • Data Sciences Leader for AI and Biomarker Innovation

    2 weeks ago

    Mississauga, Ontario, Canada F. Hoffmann-La Roche AG Full time

    Job OverviewWe are seeking a skilled Data Sciences Product Leader with extensive experience in AI and biomarker data expertise to drive technical directions and ensure strong business impacts.Key ResponsibilitiesLead the development of high-quality data integration solutions for complex clinical trial and biomarker data exploration to support strategic...

  • Data Science Leader for Cutting-Edge AI Solutions

    2 weeks ago

    Mississauga, Ontario, Canada COMPASS GROUP CANADA Full time

    At Compass Group Canada, we are a leading foodservice and support services company that employs 625,000 people worldwide. We operate in various sectors including education, healthcare, hospitality, and more.We are seeking an experienced Senior Data Scientist to join our team at Compass Digital, a member of Compass Group North America. Our mission is to...

  • Data Sciences Product Leader for AI Innovation

    2 weeks ago

    Mississauga, Ontario, Canada F. Hoffmann-La Roche AG Full time

    Principal Data Sciences Product Leader - AI and BiomarkerAbout the RoleWe are seeking a talented technical expert with in-depth AI experience and biomarker data expertise to drive technical directions and ensure strong business impacts.Your Opportunity:Lead, design, develop, implement, and deliver optimal high-quality data integration solutions needed for...

  • Machine Learning Development Manager, Generative AI

    3 weeks ago

    Mississauga, Canada SOTI Inc. North America Full time

    SOTI is committed to providing its employees with endless possibilities; learning new things, working with the latest technologies and making a difference in the world. Job Title: Machine Learning Development Manager, Generative AI Location : Mississauga, Ontario, Canada Work Model: Hybrid It all started with a classic story about one developer’s...

  • Technical Director, AI and Biomarker Data

    1 week ago

    Mississauga, Ontario, Canada F. Hoffmann-La Roche Gruppe Full time

    F. Hoffmann-La Roche Gruppe is a leading research-focused healthcare group with over 100,000 people across the globe.We are seeking a talented technical expert to drive the technical directions and ensure strong business impacts in our Data Curation and Integration Enabling Platform.Job DescriptionThe successful candidate will have in-depth experience with...

  • Embedded Systems Engineer

    4 weeks ago

    Mississauga, Ontario, Canada Qualitrol Company Full time

    Qualitrol Company is a leader in innovation and technology, providing cutting-edge solutions to the utilities and industrial sectors.The Hardware Developer will play a critical role in driving new technology initiatives and sustaining programs, working on multiple projects to deliver high-quality products that meet customer needs.This individual will be...

  • Machine Learning Development Manager, Generative Ai

    4 months ago

    Mississauga, Canada SOTI Inc. Full time

    SOTI is committed to providing its employees with endless possibilities; learning new things, working with the latest technologies and making a difference in the world. Job Title: Machine Learning Development Manager, Generative AI Location: Mississauga, Ontario, Canada Work Model: Hybrid, 3 days in-office minimum; additional occasional/or regular...

  • Machine Learning Development Manager, Generative AI

    2 weeks ago

    Mississauga, Canada SOTI Inc. North America Full time

    SOTI is committed to providing its employees with endless possibilities; learning new things, working with the latest technologies and making a difference in the world.Job Title:Machine Learning Development Manager, Generative AI Location :Mississauga, Ontario, Canada Work Model:HybridIt all started with a classic story about one developer’s vision. In...

  • AI Engineering Innovator

    4 weeks ago

    Mississauga, Ontario, Canada Johnson Electric Full time

    Job OverviewJohnson Electric is seeking a highly skilled AI Engineering Specialist to join our team in Mississauga, Ontario. This full-time position offers a competitive salary and benefits package.Job ResponsibilitiesCollaborate with cross-functional teams to develop innovative generative AI solutions that solve business problems and deliver significant...

  • Technical Director, AI Solutions

    1 week ago

    Mississauga, Ontario, Canada F. Hoffmann-La Roche Gruppe Full time

    About the OpportunityIn this highly impactful role, you will lead the development and implementation of cutting-edge AI solutions that drive strategic decision making in clinical development. Leveraging your expertise in biomarker data and Large Language Models (LLM), you will design, develop, and deliver high-quality data integration solutions to support...

  • Systems Validation and Compliance Manager

    6 months ago

    Mississauga, Canada Cliantha Research Ltd. Full time

    **Job description** Cliantha is currently seeking a **System** **Validation and Compliance Manager** who can fulfill its business needs and is looking for better learning and growth opportunities. **About Us** Cliantha Research is a full service Clinical Research Organization (CRO) that provides comprehensive and integrated offerings in Early Phase, Late...

  • Associate Director, AI Engineer

    7 months ago

    Mississauga, Canada AstraZeneca Full time

    Description Company AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to have a unique...

  • Machine Learning Technical Lead

    6 months ago

    Mississauga, Canada Symcor Inc. Full time

    About Symcor Symcor enables secure data exchanges and supporting business processes, to help clients succeed in an evolving digital world. Trusted by Canada's largest institutions for over 25 years to support their digital transformations, Symcor aligns industry participants to solve common challenges in the most effective and efficient way. Our goal is for...

  • Project Manager

    6 months ago

    Mississauga, Canada Violet Ink Full time

    Hi, Hope you are doing well. **A Technical Project manager (Generative AI)** **Location: Mississauga Canada (Onsite from day 1)** **Type: Full Time** **Must be skill required: Gen AI, ML, LLMs, Java** Must-Have Skills and Qualifications: 1. Technical Expertise: A solid understanding of the technologies and tools being utilized (such as Java, Gen AI,...

  • Digital Marketing Strategist for Amazon Expansion

    4 weeks ago

    Mississauga, Ontario, Canada SharkNinja Full time

    At SharkNinja, we are committed to delivering exceptional products that make a positive impact on people's lives. We strive for excellence in everything we do and are seeking a talented Digital Marketing Strategist to join our team.The ideal candidate will have a strong background in performance marketing, with experience in managing large budgets and...