Senior eCompliance Lead: GxP Systems & AI Enablement

Novartis México; Ciudad de México; On-site; MXN 1,200,000 - 2,000,000; Full time

Job summary

Novartis México is seeking a Senior eCompliance Manager to ensure GxP-regulated computerized systems meet evolving regulatory and data integrity expectations. You will guide compliant development and lifecycle management, harmonize eCompliance strategy, and collaborate across IT and business functions to enable responsible automation and AI adoption.

You will partner with international teams, review validation docs, and stay ahead of regulatory developments to strengthen standards and readiness

Qualifications

• Significant experience in pharmaceutical environments with regulated IT quality and compliance.
• Deep knowledge of global regulations for computerized systems, including validation and lifecycle management and 21 CFR Part 11.
• Experience developing, implementing and managing computerized systems in regulated settings.
• Experience managing quality across onsite, cloud, SaaS, mobile and digital solutions.
• Ability to collaborate across international teams, influence without formal authority, build trusted partnerships.
• Excellent communication, negotiation, facilitation and stakeholder-management skills, including interaction with management and inspectors.

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 IT and business teams on computerized system validation and compliance topics.
• Review and approve validation documentation and determine Good Practice applicability for relevant systems.
• Oversee validation status, change controls and deviations throughout the lifecycle of regulated systems.
• Provide eCompliance expertise for strategic projects, supplier assessments, audits and health authority inspections.
• Monitor regulatory and industry developments to strengthen standards and readiness.

Skills

Pharma quality

Regulatory knowledge

GxP compliance

Cross-functional collaboration

Communication and negotiation

Job description

Novartis México is seeking a Senior eCompliance Manager to ensure GxP-regulated computerized systems meet evolving regulatory and data integrity expectations. You will guide compliant development and lifecycle management, harmonize eCompliance strategy, and collaborate across IT and business functions to enable responsible automation and AI adoption.

You will partner with international teams, review validation docs, and stay ahead of regulatory developments to strengthen standards and readiness