Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

The Position:

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. 

That’s what makes us Roche.

As a Senior IT Validation Professional, you will play a pivotal role in ensuring the quality of the products we deliver. You will be responsible for evaluating, designing, developing, and approving validation plans, protocols, and reports for computerized systems across various domains and product lines. You will be part of a highly motivated, collaborative, and diverse Computer Software Assurance / Validation Team. 

The Opportunity:

Validation Strategy: You will establish validation approaches, identify deliverables for GxP computerized systems for projects, enhancements, or changes.

Documentation Review and Development: You will review system documentation, develop and approve validation plans/reports and authorize test plans/reports per Roche CSV SOPs and regulations.

Testing and Consultancy:  You will verify testing activities and provide consultancy on deviations and corrective actions as per approved procedures.

Deviation and Root Cause Analysis:  You will support deviation investigations, identify root causes, and define corrective and preventive actions.

Audit and Inspection Preparation: You will serve as a CSV subject matter expert for audit/inspection preparation and execution.

System Maintenance: You will maintain a validated system state, ensuring IT controls and audit readiness using appropriate tools.

Periodic Reviews: You will lead/support system periodic reviews per company procedures, implement continuous improvement, and provide training and knowledge sharing.

Who you are 

You will have a Bachelor's degree in relevant fields; 6+ years' experience in IT & Software Validation (CSV/CSA, GAMP) in the pharma sector.

You will bring a strong understanding of FDA regulations and guidelines, including CFR 21 FDA Part 11, Annex 11, EU GMP Annex 1, and GxP practices.

Familiarity with Cloud-based platforms (SaaS), Artificial Intelligence, EDMS (e.g., Veeva), and ALM tools (e.g., JIRA, RETINA).

You will be an expert in system and data risk assessment, Agile Methodologies (SAFe, Scrum), and proficiency in communication and collaboration within cross-functional and agile teams.

You will bring strong leadership, assertiveness, conflict management, and the ability to work effectively with diverse personalities and cultures

Relocation benefits are not eligible for this position 

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.