Global Audit and Compliance Professional

hace 2 días

Insurgentes, 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.

Division

Biomedical Research

Business Unit

Innovative Medicines

Location

Mexico

Site

INSURGENTES

Company / Legal Entity

MX06 (FCRS = MX006) Novartis Farmacéutica S.A. de C.V.

Functional Area

Quality

Job Type

Full time

Employment Type

Regular

Shift Work

No

**Accessibility and accommodation**:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

  • Global Audit and Compliance Professional

    hace 4 semanas

    Insurgentes, 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...

  • Good Clinical Practices and Pharmacovigilance Sr

    hace 4 semanas

    Insurgentes, México Novartis A tiempo completo

    **Summary**:Lead, support and report independent GCP/PV audits according to the NVS Quality Sys-tem and the current GCP/PV regulations to assess compliance with applicable regula-tions, standards, and guidance documents. Review and approve corrective action plans in support of the audit observations.Ensure alignment with strategic direction of the company...

  • Manager, Compliance

    hace 4 semanas

    Insurgentes, México Novartis A tiempo completo

    **Summary**:The Manager, Compliance & Risk Ops role supports the US Audit Readiness Lead with operational work critical to the Audit & Monitoring processes. They will be responsible for independently assessing escalated issues, communicating key information to the HYD Compliance Team Lead & US Audit Readiness Lead, and leading appropriate next steps based on...

  • Compliance Operations Manager

    hace 2 semanas

    Insurgentes, México Sandoz A tiempo completo

    Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture...

  • Financial Controls

    hace 5 días

    Insurgentes, México Novartis A tiempo completo

    **Summary**: The Manager Financial Controls & Compliance will be responsible for planning and executing high-quality controls testing and risk advisory support that meet Novartis Financial Controls Manual standards and SOX 404 requirements. This position will support ongoing FC&C activities as well as support new activities related to S4HANA Digital...

  • Specialist, Compliance

    hace 4 semanas

    Insurgentes, México Novartis A tiempo completo

    **Summary**:The Specialist, Compliance & Risk Ops role supports the Audit Readiness Team with identifying, investigating, and triaging compliance issues for tracking and resolution. They will be responsible for assessing escalated issues and communicating them to the relevant Audit Readiness Team member(s) or other stakeholders. They will also identify and...

  • Financial Controls

    hace 1 semana

    Insurgentes, México Novartis A tiempo completo

    **Summary**: The Manager Financial Controls & Compliance will be responsible for planning and executing high-quality controls testing and risk advisory support that meet Novartis Financial Controls Manual standards and SOX 404 requirements. This position will support ongoing FC&C activities as well as support new activities related to S4HANA Digital...

  • Financial Controls

    hace 1 semana

    Insurgentes, México Novartis A tiempo completo

    **Summary**:The Manager Financial Controls & Compliance will be responsible for planning and executing high-quality controls testing and risk advisory support that meet Novartis Financial Controls Manual standards and SOX 404 requirements. This position will support ongoing FC&C activities as well as support new activities related to S4HANA Digital Landscape...

  • Finance Control and Compliance Us Manager

    hace 4 semanas

    Insurgentes, México Novartis A tiempo completo

    **Summary**:In this role, you will be responsible for ensuring the overseeing and maintaining financial procedures to ensure adherence to regulations and internal policies**About the Role**:**Your key responsibilities**:Your responsibilities include, but are not limited to:- Evaluate existing processes and recommend improvements to strengthen internal...

  • Financial Controls

    hace 3 días

    Insurgentes, México Novartis A tiempo completo

    **Summary**: Dirigir la función de FRA en un país en varias divisiones O dirigir una línea de servicios/proceso/área/tecnología de FRA y asegurar la entrega del servicio de principio a fin en todas las divisiones de Novartis **About the Role**: - Location: Hybrid. CDMX Your responsibilities include, but are not limited to: - Lead the development,...