Senior eCompliance Leader: Digital Quality & AI (Hybrid)

MX06 (FCRS = MX006) Novartis Farmacéutica S.A. de C.V.; Ciudad de México; Hybrid; MXN 900,000 - 1,300,000; Full time

Job summary

Novartis Farmacéutica S.A. de C.V. in Mexico City is seeking a Senior eCompliance Manager to ensure GxP-regulated computerized systems meet evolving regulatory and data integrity expectations, guiding lifecycle management and compliant system development.

You will collaborate with IT and business teams to shape eCompliance strategy and support responsible automation adoption. The role demands experience in regulated pharma IT quality, strong communication with management and health authority

Qualifications

• Significant experience in pharmaceutical environments with regulated IT quality and compliance.
• Deep knowledge of global regulations governing computerized systems, including validation and 21 CFR Part 11.
• Experience managing lifecycle of computerized systems in regulated environments.
• Experience overseeing quality across on-site, cloud-based, SaaS, mobile and digital solutions in regulated settings.
• Strong collaboration across international teams and stakeholder management.

Responsibilities

• Lead implementation of eCompliance strategy across globally regulated computerized systems and supporting infrastructure.
• Guide compliant development and lifecycle management of computerized systems, strengthening data integrity controls.
• Drive responsible adoption of approved automation and artificial intelligence capabilities within assigned eCompliance areas.
• Partner with Information Technology and business teams on computerized system validation and compliance topics.
• Review and approve validation documentation and determine Good Practice applicability for relevant computerized systems.
• Oversee validation status, change controls and deviations throughout the lifecycle of regulated computerized systems.
• Provide eCompliance expertise for strategic projects, supplier assessments, audits and health authority inspections.
• Monitor regulatory and industry developments to strengthen standards, quality processes and emerging-technology readiness.

Skills

GxP compliance

Regulatory knowledge

Quality systems

Stakeholder management

Data integrity

Cloud/SaaS compliance

Automation/AI in regulated env

Job description

Novartis Farmacéutica S.A. de C.V. in Mexico City is seeking a Senior eCompliance Manager to ensure GxP-regulated computerized systems meet evolving regulatory and data integrity expectations, guiding lifecycle management and compliant system development.

You will collaborate with IT and business teams to shape eCompliance strategy and support responsible automation adoption. The role demands experience in regulated pharma IT quality, strong communication with management and health authority