Computer Systems Compliance Lead

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.

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 worlds 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**

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.

A healthier future drives us to innovate. Together more than 100000 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.

Lets build a healthier future together.