Senior eCompliance Manager
Novartis is hiring a Senior eCompliance Manager. Level rates it ; you can apply on Novartis.
Level's read on this job
- Level rates this role Little AI ●○○○: aI is not part of the work.
- The posting mentions compliance, computerized system validation and data integrity among its tools and skills.
- Level classes it as a senior role.
- Novartis has 864 other open roles on Level.
AI in this role
Oversee eCompliance and GxP computerized systems quality, supporting responsible adoption of automated technologies.
Job Description Summary
#LI-HybridLocation: 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 e-mail to tas.mexico@novartis.com 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 tas.mexico@novartis.com y permítanos conocer la naturaleza 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, StorytellingHow we rate this
Senior eCompliance Manager at Novartis rates 15 out of 100 for how much of the daily work is AI. That makes it Little AI (AI Level 1 of 4). The level is about AI in the job, not seniority.
Little AI. AI is not part of the work.
- ●●●● Builds AI80 to 100
- ●●●○ Works on AI60 to 79
- ●●○○ Uses AI40 to 59
- ●○○○ Little AI0 to 39
Levels come from how often the tools, models and workflows of the role are named in the posting itself. Read the description and count the AI tools, models and workflows it names.
Prepare for this job
Built from this posting and from similar jobs on Level.
Skills and AI tools this role asks for
Questions you could be asked
- Tell me about a project where compliance was part of your work. What did you do?
- Tell me about a project where computerized system validation was part of your work. What did you do?
- Tell me about a project where data integrity was part of your work. What did you do?
Adapt your resume
- List these exact terms on your resume: Compliance, Computerized System Validation, and Data Integrity. An applicant tracking system matches the wording, not the idea.
- Attach one line of real, concrete experience to at least one of them. A tool named with nothing behind it rarely survives a human read.
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