Summary:
The Audit and Compliance Specialist is responsible for the compliance and Quality Assurance support of the GxP computerized systems including supplier quality assessment/management throughout their lifecycles in regards to the applicable regulations and requirements defined in the Novartis Quality Manual and procedures. eCompliance provides guidance on CSV related topics and related information.
- Reviews and/or approves the qualification and operational deliverables of respective GxP computerized systems. Managing work in accordance with the law, internal regulations, good practices and business objectives.

About the Role:
Major Accountabilities:
- Ensure all site activities comply with cGxP, regulatory requirements, company quality standards, and data integrity expectations.
- Plan, support, review, and approve key quality activities including PQR/APQR, validation, qualification, change controls, CAPAs, deviations, and follow-up actions.
- Implement and maintain Quality Systems, including documentation management, process quality assurance, KPI trending,



and continuous improvement initiatives.
- Provide quality oversight for GxP computerized systems, including classification, qualification, supplier assessment, lifecycle management, risk mitigation, and review/approval of related documentation.
- Support audit and inspection readiness, including preparation, coordination, participation, follow-up, and communication with internal and external stakeholders.
- Manage supplier quality activities, including quality agreements, oversight, audits, and ensuring compliance with applicable Novartis and regulatory requirements.
- Comply with HSE requirements, participate in risk assessments and audits, report potential risks, complete required training, and contribute to personal development while representing the company’s values.

Obligatory requirements:
- Education: Degree in chemistry, biology, computer science, life sciences
- Minimum 3 years of overall autom

📌 Audit and Compliance Specialist (Baja California Sur)
🏢 Novartis
📍 Baja California Sur