Audit and Compliance Specialist

Biopharma Careers; Ciudad de México; Presencial; MXN 480.000 - 620.000; Jornada completa

Descripción de la vacante

Novartis is seeking an Audit and Compliance Specialist to support GxP computerized systems and supplier quality management across their lifecycles. The role focuses on regulatory compliance, data integrity, and quality assurance in alignment with the Novartis Quality Manual.

The candidate will review and approve qualification deliverables, support audits, and maintain quality systems while ensuring adherence to internal regulations and business objectives.

Formación

• Education: Degree in chemistry, biology, computer science, or life sciences.
• Minimum 3 years of automation/CSV experience, or 3 years in a Laboratory.
• Fluent written and spoken English; Spanish desirable.
• Solid quality experience in inspections and audits to ensure compliance.
• Excellent knowledge of Microsoft Office.

Responsabilidades

• Ensure site activities comply with cGxP, regulatory requirements and data integrity standards.
• Plan, review, and approve quality activities including PQR/APQR, validation, change controls and CAPAs.
• Maintain Quality Systems, documentation management, KPI trends, and continuous improvement.
• Provide quality oversight for GxP computerized systems and supplier lifecycle management.
• Support audit and inspection readiness, including coordination with stakeholders.
• Manage supplier quality activities, audits, and compliance with regulatory requirements.
• Act as a point of contact for Health Authorities and compliance partners; manage certificates and submissions.
• Comply with HSE requirements and participate in risk assessments and training.

Conocimientos

Quality assurance

Regulatory compliance

GxP

CSV

Audits

Data integrity

Communication

Microsoft Office

Educación

Degree in chemistry

Degree in biology

Degree in computer science

Degree in life sciences

Herramientas

Microsoft Office

Descripción del empleo

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.

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 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 automation/CSV experience, or a minimum of 3 years of Laboratory.
• Strong drive to learn, a commitment to accuracy and excellent communication skills.
• Solid quality experience in inspections and audits as essential to maintaining high standards and ensuring compliance.
• Excellent knowledge of Microsoft Office
• Fluent English, written and spoken. Spanish is desirable.

Why Novartis

Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

You’ll receive

• You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

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.

Join our Novartis Network

If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.