At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
The PositionAt Roche, we are motivated by a single purpose: Doing now what patients need next. As a global leader in healthcare and a pioneer in pharmaceuticals and diagnostics, we are dedicated to transforming the lives of patients through ground-breaking science and innovation. With a history spanning over 125 years, our commitment to excellence and our passion for improving human health have made us one of the world's most influential healthcare organizations. By joining Roche, you become part of a diverse and inclusive community of experts focused on delivering personalized healthcare and pushing the boundaries of medical possibility.The OpportunityAs a Principal QA Information Systems Engineer within our Cell & Gene Therapies (CGT) team, 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.
You are a visionary technical leader with a passion for quality and the ability to thrive in a high-stakes, matrixed global environment. You combine deep regulatory knowledge with the agility required to support the next generation of medical therapies.
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 and 179,728.50 of hiring range. Actual pay will be determined based on experience, qualifications, and other job-related factors as determined by the company.We use artificial intelligence to screen, assess or select applicants for this role.
This posting is for an existing vacancy at Hoffmann-La Roche Ltd.
Who we areA healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.
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