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Roche

Computer Systems Compliance Lead

Roche

. Define and implement risk-based Computer Systems Validation (CSV) and Quality Assurance (QA) strategies across global networks .

Posted 9/24/2026full-timeMississauga • CanadaSenior💰 CA$105,560 - CA$138,548 per yearWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates expertise in Computer Systems Validation (CSV) and Quality Assurance (QA) strategies, with a strong focus on GxP regulations and compliance within the pharmaceutical industry. Proven ability to lead cross-functional teams and drive continuous improvement initiatives in computerized systems.

Highest-signal resume keywords
Computer Systems Validation (CSV)Good Manufacturing Practice (GMP)GxP RegulationsQuality Assurance (QA)SAP Implementation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Quality Control (QC)Data Integrity PrinciplesSystems ManagementTesting ToolsValidation Frameworks
Soft Skills
CollaborationCommunicationCoachingProblem-Solving
Tools & Technologies
ALMGitLabJiraServiceNowSAP Solution Manager
Industry Keywords
Pharmaceutical IndustryComputer System Software Architecture (CSA)Continuous ImprovementInspection ReadinessSystem Deviations

Tech Stack

Tools & technologies
ERPServiceNow

About the role

Key responsibilities & impact
  • 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, 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
  • Lead periodic reviews of global computer systems
  • Champion a Speak Up culture and foster open communication and collaborative problem-solving across sites
  • Identify and lead continuous improvement initiatives using emerging trends in Computer System Software Architecture (CSA) and validation frameworks

Requirements

What you’ll need
  • Degree in Physical Sciences, Computer Science, or a related field
  • 5+ years of hands-on experience in QA, QC, or ERP systems within the pharmaceutical industry
  • 5+ years of expertise in GxP regulations, Computer Systems Validation (CSV), and Data Integrity principles
  • Proven experience supporting QC/QA/ERP system implementations, such as SAP, across the system lifecycle
  • Experience with systems management and testing tools such as ALM, GitLab, Jira, ServiceNow, or SAP Solution Manager
  • Ability to collaborate, communicate clearly, coach colleagues, and guide cross-functional stakeholders
  • Relocation is not offered for this position

Benefits

Comp & perks
  • Inclusive culture valuing personal expression, open dialogue, and genuine connections
  • Relocation not offered for this position
  • Equal opportunity employer