Principal QA Information Systems Engineer

Principal QA Information Systems Engineer – Cell & Gene Therapies (CGT)

You will be at the forefront of delivering life-changing individualized treatments. You will provide critical quality oversight and technical expertise to ensure our enterprise systems and CGT-specific applications are robust, compliant, and innovative.

• Serve as the primary Quality Subject Matter Expert (SME) for CGT ERP systems and technical applications, including orchestration and exceptions management systems
• Collaborate with global cross-functional teams to define, design, deploy, and maintain enterprise systems that strictly adhere to regulatory requirements and quality standards
• Translate complex business needs into streamlined process flows and detailed user requirements by leveraging deep expertise in SAP and relevant technical platforms
• Develop, implement, and lead a comprehensive data integrity program that remains compliant with evolving global regulatory standards and industry best practices
• Directly support internal and external audits, manage deviations/CAPAs, and oversee the resolution of IT-related quality records to safeguard product traceability
• Drive continuous improvement initiatives within Roche’s Quality Management System (QMS) to align our policies and procedures with emerging global regulations
• Act as a strategic bridge between Manufacturing, Quality, IT, and Supply Chain to ensure seamless implementation and compliance of all CGT-supporting technologies

Qualifications

• You possess a Bachelor’s or Post‑Graduate degree in Science, Engineering, or a related field, supported by at least 10 years of quality experience in the pharmaceutical or biotech industry
• You demonstrate deep expertise in Cell & Gene Therapy (CGT) alongside a profound understanding of GxPs, FDA/EMA regulations, and global data integrity requirements
• You are skilled at collaborating with and influencing stakeholders across diverse functions and geographies within a complex, global organization
• You exhibit a proactive "can‑do" attitude with the analytical precision necessary to solve complex problems and drive results in evolving technical landscapes
• You are an exceptional communicator, capable of distilling both strategic objectives and tactical solutions into clear, concise, and impactful messaging
• You possess advanced negotiation and influencing skills, enabling you to achieve critical outcomes with global operations, external partners, and suppliers
• You are highly adaptable and culturally aware, with the autonomy to manage multiple priorities and the willingness to travel internationally to support our global mission
• Relocation benefits not eligible for this position. The expected salary range for this position based on the primary location of Mississauga is 136,936.00 to 179,728.50. Actual pay will be determined based on experience, qualifications, and other job‑related factors as determined by the company.

Roche is an Equal Opportunity Employer.