Band
Level 3

Job Description 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.

Job Description
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.
- Act as a key point of contact for Health Authorities and internal compliance partners, ensuring aligned communication, certificate maintenance, applications, and regulatory submissions as required.
- Comply with HSE requirements, participate in risk assessments and audits, report potential risks, complete requir

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