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At Roche, we thrive to deliver more benefits to our patients as part of our 10-year Pharma vision. An integral part of achieving this vision is to deliver new and innovative data analytics solutions to our scientists across Pharma Technical Operations (PT). PTE is the organization that catalyzes the global development and execution of PT’s Digital and Operational Excellence strategy to enable PT to realize our performance promises.  We aim to activate data citizenship and digital mind, revolutionize our FAIR data ecosystem and systems landscape, re-design excellent processes, and generate transformative insights.

As a Data/AI Validation Specialist at Roche PT, you will play a pivotal role in optimizing access to the data insight that powers our pharmaceutical operations. This role is involved in validating AI models, data pipelines, and algorithms to meet business objectives, regulatory standards, and quality benchmarks. Working in multidisciplinary teams, you’ll execute and deploy deliverables based on the existing standards integral to our validation framework.

The Opportunity:

You will author validation plans/reports, forecast validation activities, and  review test plans/reports (and other deliverables) ensuring documentation is according to procedures. 

You will steer key performance indicators for performance and comprehensive product validation and participate in the traceability of data quality issues, effective problem identification and root cause analysis

You will coordinate and advise on all validation activities on a global level/organizational level and collaborate with data product teams for delivery of qualified global data products.

You will validate comprehensive end-to-end data product and AI Model programs (including validation plans, protocols, and reports) and support audit/inspection preparation and execution as CSV subject matter expert.

You will collaborate with quality assurance teams to ensure adherence to regulatory standards and industry best practices and ensure data validation practices comply with industry regulations such as regulatory guidelines, GDPR, HIPAA, or other standards.

Who you are:

You have a bachelor's or Master's degree in Computer Science, Engineering, Statistics, or a related field.  3+ years experience in IT & Software Validation (CSV, GAMP), preferably in pharma environment

You have experience in software development lifecycle processes (SDLC), models, standards

You have experience in validation for projects,  systems maintenance and related deliverables

You have experience in maintenance and support of applications under global inspection agencies, CFR 21 FDA Part 11, Annex 11. Broad knowledge in Manufacturing(Clinical or Commercial experience) , or Experience with Supply Chain or Regulatory.

You have a strong understanding of database management, data analysis, and quality assurance practices.

Relocation benefits are not available for this posting.

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche Pharma Canada has its office in Mississauga, Ontario and employs over 850 employees. The Mississauga facility is bright, vibrant, fosters collaboration and teamwork, and is reflective of Roche's truly innovative culture.

Roche is an Equal Opportunity Employer.