Senior eCompliance Lead, GxP & Digital Quality

Novartis AG; Guamúchil; Hybrid; MXN 1,200,000 - 1,800,000; Full time

Job summary

Novartis AG in Mexico City is seeking a Senior eCompliance Manager to shape how digital quality enables innovation and ensure GxP-regulated computerized systems meet evolving regulatory and data integrity expectations.

You will lead cross-functional teams, guide lifecycle management of computerized systems, and influence eCompliance strategy while supporting automation and AI adoption in regulated environments.

Qualifications

• Significant experience in pharmaceutical environments, particularly within regulated Information Technology quality and compliance functions.
• Deep knowledge of global regulations governing computerized systems, including validation, lifecycle management and 21 CFR Part 11.
• Strong experience developing, implementing and managing computerized systems throughout their lifecycle in regulated environments.
• Experience managing quality across onsite, cloud-based, software-as-a-service, mobile and digital solutions in regulated settings.
• Demonstrated ability to collaborate across complex international teams, influence without formal authority and build trusted partnerships.
• Excellent communication, negotiation, facilitation and stakeholder-management skills, including interaction with management and health authority 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 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

Audits Compliance

Business Acumen

Business Partnerships

cGMP Compliance

Change Management

Communication

Data Integrity

Decision Making

Digital Fluency

Internal Auditing

Leadership

Managing Ambiguity

Problem Solving

Quality Auditing

Quality Compliance

Quality Management

Quality Management System (QMS)

QMS

Regulatory Compliance

Stakeholder Management

Storytelling

Job description

Novartis AG in Mexico City is seeking a Senior eCompliance Manager to shape how digital quality enables innovation and ensure GxP-regulated computerized systems meet evolving regulatory and data integrity expectations.

You will lead cross-functional teams, guide lifecycle management of computerized systems, and influence eCompliance strategy while supporting automation and AI adoption in regulated environments.