Computer Systems Compliance Lead

Job summary

Define and implement risk-based computer systems validation and quality assurance strategies, oversee GMP compliance and inspection readiness, and serve as the quality subject matter expert for system deviations, CAPAs, and investigations. Collaborate with global cross-functional teams, approve system releases, lead periodic system reviews, and drive continuous improvement in validation practices.

Job details

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 Position At 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. Who we are A 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.

What you’ll do

Define and implement risk-based computer systems validation and quality assurance strategies, oversee GMP compliance and inspection readiness, and serve as the quality subject matter expert for system deviations, CAPAs, and investigations. Collaborate with global cross-functional teams, approve system releases, lead periodic system reviews, and drive continuous improvement in validation practices.

Requirements

A degree in physical sciences, computer science, or a related field and at least five years of hands-on QA, QC, or ERP systems experience in the pharmaceutical industry are required. Candidates should have at least five years of expertise in GxP, CSV, and data integrity, experience supporting QC/QA/ERP implementations such as SAP, and familiarity with tools such as ALM, GitLab, Jira, ServiceNow, or SAP Solution Manager.

Listed skills

• Continuous Improvement · Preferred
• SAP · Preferred
• ERP systems · Preferred
• Quality assurance · Preferred
• System Implementations · Preferred
• Cross-Functional Collaboration · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Computer Systems Validation
• Quality Assurance
• GMP Compliance
• GxP Regulations
• Data Integrity
• Risk-Based Validation
• CAPA Management
• Deviation Management
• Investigations
• ERP Systems
• SAP
• System Implementations
• System Lifecycle Management
• Inspection Readiness
• Cross-Functional Collaboration
• Continuous Improvement
• Test Tools
• Physical Science
• Research
• Agile Methodology
• Artificial Intelligence
• JIRA
• Good Manufacturing Practices
• Corrective And Preventive Action (CAPA)
• Communication
• Computer Science
• Computer System Validation
• Continuous Improvement Process
• Creativity
• System Administration
• Enterprise Resource Planning
• Leadership
• Problem Solving
• Operations
• Pharmaceuticals
• Coaching
• Safety Assurance
• SAP Applications
• SAP Solution Manager
• System Lifecycle
• System Software
• Investigation
• Gitlab
• Quality Control
• ServiceNow

Job areas

• Healthcare
• Technology
• Management & Leadership
• Manufacturing
• Computer Systems Manager
• Quality Assurance Manager
• Management and Organization Analysts
• Quality Control Systems Managers
• Industrial Production Managers

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