Senior eCompliance Manager

Novartis AG; Guamúchil; Hybrid; MXN 1.200.000 - 1.800.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

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

Jobbeschreibung

Job Description Summary

#LI-Hybrid

Location: Mexico City, Mexico

Relocation Support: This role is based in Mexico City, Mexico. Novartis is unable to offer relocation support: please only apply if accessible.

Shape how digital quality enables innovation at Novartis. As Senior eCompliance Manager, you'll help ensure GxP-regulated computerized systems and emerging technologies meet evolving regulatory and data integrity expectations, while guiding teams through compliant system development and lifecycle management.

You'll partner across Information Technology and business functions, influence eCompliance strategy, and support the responsible adoption of automation and artificial intelligence. This is an opportunity to combine deep quality expertise with a forward-looking mindset and help build a strong, future-ready digital compliance environment.

Job Description

Major Accountabilities:

• 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.

Obligatory Requirements:

• 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.

Desirable Requirements:

• Knowledge of data governance, data integrity, analytics, key performance indicators and key quality indicators.
• Understanding of cloud technologies, cybersecurity, automation, artificial intelligence and digital transformation in regulated environments.

Commitment to Diversity and Inclusion

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Accessibility and Accommodation:

Novartis is committed to work with and provide reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an email to [e-mail] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Novartis tiene el compromiso de trabajar y proporcionar adaptaciones razonables para personas con discapacidad. Si, debido a una condición médica o discapacidad, necesita una adaptación razonable para cualquier parte del proceso de contratación, o para desempeñar las funciones esenciales de un puesto, envíe un correo electrónico a [e-mail] y permítanos conocer la natureza de su solicitud y su información de contacto. Incluya el número de posición en su mensaje.

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Why Novartis:

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards:

Learn about all the ways we’ll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)

Skills Desired

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) Compliance, Quality Management Systems (QMS), Regulatory Compliance, Stakeholder Management, Storytelling