The PositionAt Roche, we believe that every patient deserves access to life-changing innovations. As a global healthcare leader operating across pharmaceuticals and diagnostics, we combine cutting-edge science, advanced technology, and a passion for improving lives to address some of the world’s most challenging medical needs. Driven by our commitment to research and sustainable healthcare solutions, we foster an inclusive, collaborative environment where diverse teams are empowered to question the status quo, drive continuous improvement, and redefine what is possible in modern medicine.
The Opportunity
- Define and implement risk-based Computer Systems Validation (CSV) and Quality Assurance (QA) strategies across global networks.
- Oversee Good Manufacturing Practice (GMP) compliance and inspection readiness for computerized systems supporting global operations.
- Serve as the Primary Quality Subject Matter Expert and point of contact for system deviations, Corrective and Preventive Actions (CAPAs), and investigations.
- Collaborate as a Quality representative on cross-functional, multi-site teams to resolve complex compliance challenges.
- Approve system releases according to CSV standards and lead periodic reviews of global computer systems.
- Champion a Speak Up culture while fostering open communication and collaborative problem-solving across sites.
- Identify and lead continuous improvement initiatives by applying emerging trends in the Computer System Software Architecture (CSA) and validation frameworks.
Who You Are
- You bring a degree in Physical Sciences, Computer Science, or a related field AND 5+ years hands-on experience in QA, QC, or Enterprise Resource Planning (ERP) systems within the pharmaceutical industry.
- You possess 5 years +years of demonstrated expertise in GxP regulations, Computer Systems Validation (CSV), and Data Integrity principles.
- You have a proven track record supporting QC/QA/ERP system implementations (e.g., SAP) across the system lifecycle.
- You are comfortable working with systems management and testing tools such as ALM, Gitlab, Jira, ServiceNow, or SAP Solution Manager.
- You are an agile collaborator and clear communicator who enjoys coaching colleagues and guiding cross-functional stakeholders toward best practices.
**Relocation not offered for this position**
The expected salary range for this position based on the primary location of Mississauga is 105,560.00 and 138,547.50 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.
