Global Audit And Compliance Professional

hace 3 semanas

Xico, México Novartis A tiempo completo

**Summary**:Conduct and support GLP/GCLP audits, including integrations and non-GxP assessments, following the Novartis Quality System and current regulations.Ensure compliance with applicable standards and guidance documents.Review and approve corrective action plans for audit observations.**About the Role**:**Major accountabilities**:- Support 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.- Liaise as needed with the third-party management team.- Proactively research local and global initiatives, trends and events that impact maintenance of compliance.Maintain current knowledge of regulations, standards and guidance documents.**Key performance indicators**:- Complete 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.- Escalate issues through proper channels promptly.- Communicate and support business partners thoroughly and accurately.**Minimum Requirements**:**Work Experience**:- 7+ years of GLP/GCP/Pharmaceutical Industry/Health Authority experience or equivalent.- 5 years of GCP/PV auditing experience**Skills**:- Ability to independently manage and objectively evaluate complex compliance issues with mínimal supervision.- Experience with Health Authority inspections- Excellent verbal and written communication, organizational and interpersonal skills.- Knowledge of applicable GxP regulations, guidelines, policies, and procedures.- Good knowledge of computer systems validation and 21CFR Part 11 requirements.- Leadership and facilitation skills- International travel expectation 25%.**Languages**:- English.DivisionBiomedical ResearchBusiness UnitInnovative MedicinesLocationMexicoSiteINSURGENTESCompany / Legal EntityMX06 (FCRS = MX006) Novartis Farmacéutica S.A. de C.V.Functional AreaQualityJob TypeFull timeEmployment TypeRegularShift WorkNo**Accessibility and accommodation**:Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

  • Audit Professional

    hace 2 semanas

    Xico, México Bebeeauditor A tiempo completo

    Lead Auditor Our team seeks a professional to provide expert audit services and support various Assurance engagements. Job Description: We are seeking an experienced auditor to lead audit teams in obtaining reasonable assurance about whether financial statements are free from material misstatement. This involves evaluating compliance with regulations,...

  • Audit Professional

    hace 2 semanas

    Xico, México Bebeeauditor A tiempo completo

    Lead Auditor Our team seeks a professional to provide expert audit services and support various Assurance engagements. Job Description: We are seeking an experienced auditor to lead audit teams in obtaining reasonable assurance about whether financial statements are free from material misstatement. This involves evaluating compliance with regulations,...

  • Audit Professional

    hace 2 semanas

    Xico, México Bebeeauditor A tiempo completo

    Lead Auditor Our team seeks a professional to provide expert audit services and support various Assurance engagements. Job Description: We are seeking an experienced auditor to lead audit teams in obtaining reasonable assurance about whether financial statements are free from material misstatement. This involves evaluating compliance with regulations,...

  • Senior Audit Manager – Corporate

    hace 3 semanas

    Xico, México Hsbc Global Services Limited A tiempo completo

    A leading financial services company in Mexico seeks an Audit Manager for its Global Internal Audit team.Responsibilities include managing audit activities, ensuring compliance, and recommending improvements.The ideal candidate will have 5–8 years of experience in the financial services sector and strong managerial skills.The role requires a bachelor's...

  • Manager, Infrastructure And Cloud Security Audit

    hace 3 días

    Xico, México S&P Global A tiempo completo

    The Role :Manager - Infrastructure and Cloud Security AuditThe Location :Mexico or CanadaThe Team :S&P Global is a leader in credit ratings, benchmarks and analytics for the global capital and commodity markets.Reporting to the Global Head - Technology Audit & Data Analytics, you will be part of a global and diverse team with coverage for enterprise-wide...

  • Manager, Infrastructure And Cloud Security Audit

    hace 3 días

    Xico, México S&P Global A tiempo completo

    The Role :Manager - Infrastructure and Cloud Security AuditThe Location :Mexico or CanadaThe Team :S&P Global is a leader in credit ratings, benchmarks and analytics for the global capital and commodity markets.Reporting to the Global Head - Technology Audit & Data Analytics, you will be part of a global and diverse team with coverage for enterprise-wide...

  • Senior Audit Professional

    hace 3 semanas

    Xico, México Bebeeaudit A tiempo completo

    Job OpportunityDelivering Exceptional Audit ServicesWe seek a highly skilled professional to play a pivotal role in delivering top-notch audit services and ensuring compliance with rigorous accounting standards. Audit Expertise : Conduct comprehensive audits and maintain the highest level of quality. Problem Analysis : Analyze intricate issues, identify...

  • Senior Audit Professional

    hace 3 semanas

    Xico, México Bebeeaudit A tiempo completo

    Job OpportunityDelivering Exceptional Audit ServicesWe seek a highly skilled professional to play a pivotal role in delivering top-notch audit services and ensuring compliance with rigorous accounting standards. Audit Expertise : Conduct comprehensive audits and maintain the highest level of quality. Problem Analysis : Analyze intricate issues, identify...

  • Senior Audit Professional

    hace 3 semanas

    Xico, México Bebeeaudit A tiempo completo

    Job OpportunityDelivering Exceptional Audit ServicesWe seek a highly skilled professional to play a pivotal role in delivering top-notch audit services and ensuring compliance with rigorous accounting standards. Audit Expertise : Conduct comprehensive audits and maintain the highest level of quality. Problem Analysis : Analyze intricate issues, identify...

  • Senior Audit Professional

    hace 3 semanas

    Xico, México Bebeeaudit A tiempo completo

    Job OpportunityDelivering Exceptional Audit ServicesWe seek a highly skilled professional to play a pivotal role in delivering top-notch audit services and ensuring compliance with rigorous accounting standards.Audit Expertise : Conduct comprehensive audits and maintain the highest level of quality.Problem Analysis : Analyze intricate issues, identify areas...