Job Description
SummaryConduct and support GLP/GCLP audits, including integrations and non-GxP assessments, following the Novartis Quality System and current regulations. Review and approve corrective action plans for audit observations.

Location:
Insurgentes, Mexico City#LI-HybridJob DescriptionMajor accountabilitiesSupport the strategic development of an effective global risk-based audit strategy and program; collect, collate, and incorporate input into audit strategy and plan.
Lead, plan, conduct, document and follow-up of global quality regulatory compliance audits of GLP/GCLP according to the requirements specified in the respective Novartis Quality Module. Assess the adequacy of responses (CAPA plans) to audit findings.
Conduct assessments for companies and their vendors during BD&L; integration activities including non-GxP assessments, which include, but not limited to data reviews, IT system evaluations.
Provide technical guidance, leadership, mentoring and training of other auditors on audit related activities.
Ensure appropriate escalation to responsible management in case of critical findings and support immediate follow-up measures accordingly.
Identify and communicate quality and regulatory compliance issues to Quality Management and recommend remediation.
Proactively research local and integral initiatives, trends and events that impact maintenance of compliance.



Key performance indicatorsComplete audits/assessments promptly and accurately.
Ensure findings and reports meet timelines, procedures, and Key Quality Indicators (KQIs). Analyze audit metrics and non-compliance causes effectively.3+ years of GxP auditing experience. GCP/PV/GLP auditing experience preferred.
International travel expectation 25%undefinedSkillsAbility to independently manage and objectively evaluate complex compliance issues with minimal supervision.
Additional languages including German and French considered a plusCommitment to Diversity & InclusionNovartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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 ** y permítanos conocer la naturaleza de su solicitud y su información de contacto. DesiredAuditing (Inactive), Audits Compliance, Business Partnerships, Commercial Acumen, Communication, Continuous Learning, Decision Making, Employee Perfo#J-*-Ljbffr

📌 Laboratory Auditor (Veracruz)
🏢 Novartis
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