Global Computer Systems Compliance Lead (CSV/QA)

Roche; Madrid; On-site; EUR 60,000 - 90,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

QA

QC

ERP systems

CSV experience

GxP regulations

Data Integrity

SAP

Education

Physical Sciences / Computer Science degree

Tools

ALM

GitLab

Jira

ServiceNow

SAP Solution Manager

Job description

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.