Computer Systems Compliance Lead

Roche; Madrid; Presencial; EUR 60.000 - 90.000; Jornada completa

Descripción de la vacante

Roche is a global healthcare leader seeking a QA/CSV expert to define risk-based validation strategies and ensure GMP-compliant computerized systems across sites. You will collaborate with cross-functional teams and act as the primary SME for deviations and CAPAs.

Ideal candidates bring 5+ years in QA/CSV within pharma, strong data integrity knowledge, and experience with ERP systems such as SAP, plus familiarity with ALM, Jira, and ServiceNow.

Formación

• Degree in Physical Sciences, Computer Science, or related field.
• 5+ years hands-on experience in QA, QC, or ERP within pharma.
• 5+ years+ expertise in GxP, CSV, and Data Integrity.

Responsabilidades

• Define and implement risk-based CSV and QA strategies across global networks.
• Oversee GMP compliance and inspection readiness for computerized systems.
• Serve as the primary Quality SME and point of contact for deviations, CAPAs, investigations.
• Collaborate with cross-functional, multi-site teams to resolve compliance challenges.
• Approve system releases per CSV standards and lead periodic system reviews.
• Champion Speak Up culture and foster open communication across sites.
• Identify and lead continuous improvement using CSA trends and validation frameworks.

Conocimientos

QA

QC

ERP systems

CSV experience

GxP regulations

Data Integrity

SAP

Educación

Physical Sciences / Computer Science degree

Herramientas

ALM

GitLab

Jira

ServiceNow

SAP Solution Manager

Descripción del empleo

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.