Audit and Compliance Specialist

About the role

The Audit and Compliance Specialist supports compliance and quality assurance for GxP computerized systems, including supplier quality assessment and management across their lifecycles, in line with the Novartis Quality Manual and procedures. The role reviews and approves qualification and operational deliverables of GxP computerized systems and manages work according to the law, internal regulations, good practices and business objectives.

Key responsibilities

• Ensure site activities comply with cGxP, regulatory requirements, company quality standards and data integrity expectations.
• Plan, support, review and approve quality activities such as PQR/APQR, validation, qualification, change controls, CAPAs, deviations and follow-up actions.
• Maintain quality systems, including documentation management, process quality assurance, KPI trending and continuous improvement.
• Oversee GxP computerized systems: classification, qualification, supplier assessment, lifecycle management, risk mitigation and 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 compliance with Novartis and regulatory requirements.
• Act as a contact for Health Authorities and internal compliance partners, covering certificates, applications and regulatory submissions.
• Comply with HSE requirements, take part in risk assessments and audits, report risks, complete required training and represent the company's values.

Required profile

• Degree in chemistry, biology, computer science or life sciences.
• At least 3 years of overall automation/CSV experience, or at least 3 years in a laboratory.
• Solid quality experience in inspections and audits.
• Strong drive to learn, commitment to accuracy and excellent communication skills.
• Fluent written and spoken English; Spanish is desirable.

Required skills

• Excellent knowledge of Microsoft Office.
• Experience with cGxP, validation, CAPA and supplier quality.