Compliance & Quality System Manager

4 settimane fa

Ivrea, Italia Novartis A tempo pieno

**Summary**:

- Manage cost effective GxP Compliance and/or Audit activities, operations and systems to ensure compliance of business areas with the Novartis Quality Manual and Policies and all relevant GxP, legal and regulatory requirements, and through internal audits, KPIs (Key Performance Indicators) and KQIs (Key Quality Indicators) -Lead the preparation and management of external and corporate audits and Health Authority inspections.

**About the Role**:
**Major accountabilities**:

- Oversight and implementation of Quality Management System -Incident management.
- GxP Audit and inspection management -Site Regulatory oversight (incl. Reg-CMC facilitation) -Exception management -Supplier Quality management (local) -Qualification and validation -Quality Compliance -Data Integrity and eCompliance -Site KPI / KQI maintenance / reporting -Initiate and drive local hiring process -Line responsibility and daily walkthrough -Lead OpEx Projects -Investigation of Deviation, OOx, Complaints -Define and implement CAPAs -Support transfer projects and validation studies -Track team metrics and ensure KQI/KPI meet requirements -Review and approve text and design -HSE incidents reporting and action follow-up -New equipment commissioning support (OQ, PQ) -Define improvement areas in process and products -Resource and capacity (people and equipment) planning and workload management -Performance and leadership support to specialist team -Ensure availability of equipment, chemicals and consumables, as appropriate -SOP review and revision -Perform local training and monitor training status -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

**Key performance indicators**:

- Successful support of projects with agreed quality and delivery dates, passing of internal and external inspections.
- Meet quality and timelines for all projects.
- Act in accordance with Novartis standards.
- The number and severity of cGMP issues identified during internal and external audits -Year-end figures within budget.
- Successful coordination of departmental operational activities

**Minimum Requirements**:
**Work Experience**:

- Functional Breadth.
- People Leadership.
- Project Management.
- Collaborating across boundaries.
- Critical Negotiations.
- Operations Management and Execution.

**Skills**:

- Agility.
- Auditing.
- Business Acumen.
- Business Partnering.
- Collaboration / Teamwork.
- Communication Skills.
- Compliance Audits.
- Continuous Learning.
- Dealing With Ambiguity.
- Decision Making Skills.
- Employee Performance Evaluations.
- Finance Acumen.
- Gmp Procedures.
- Goal Oriented.
- Health Authorities.
- Leadership.
- Logical Thinking.
- Major Incident Management.
- People Management.
- Problem Solving Skill.
- Problem Solving Skills.
- Qa (Quality Assurance).
- Self Awareness.
- Smart Risk Taking.
- Stakeholder Management.
- Technological Expertise.
- Audit Management.
- Inspection Readiness.
- Product release.
- Organizational skills.

**Languages**:

- English.

Division

Operations

Business Unit

Innovative Medicines

Location

Italy

Site

Ivrea

Company / Legal Entity

IT58 (FCRS = IT058) AAA Italy Srl.

Functional Area

Quality

Job Type

Full time

Employment Type

Regular

Shift Work

No

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

  • Compliance & Quality System Manager

    4 settimane fa

    Ivrea, Italia Novartis A tempo pieno

    **Summary**: ~Verwalten Sie kostengünstige GxP-Compliance - und/oder Audit-Aktivitäten, -Abläufe und -Systeme, um die Einhaltung des Qualitätshandbuchs und der Richtlinien von Novartis sowie aller relevanten GxP-, gesetzlichen und regulatorischen Anforderungen sowie durch interne Audits, KPIs (Key Performance Indicators) und KQIs (Key Quality Indicators)...

  • Compliance & Quality System Manager

    4 settimane fa

    Ivrea, Italia Novartis A tempo pieno

    **Summary**: ~Beheer kosteneffectieve GxP Compliance - en/of Audit-activiteiten, -activiteiten en -systemen om ervoor te zorgen dat bedrijfsonderdelen voldoen aan de Novartis Quality Manual and Policies en alle relevante GxP-, wet - en regelgevingsvereisten, en door middel van interne audits, KPI's (Key Performance Indicators) en KQIs (Key Quality...

  • Compliance & Quality System Manager

    3 settimane fa

    Ivrea, Italia Novartis A tempo pieno

    **Summary**: ~Gestire attività, operazioni e sistemi di conformità GxP e/o audit convenienti per garantire la conformità delle aree aziendali al Manuale e alle politiche di qualità di Novartis e a tutti i requisiti GxP, legali e normativi pertinenti, nonché attraverso audit interni, KPI (Key Performance Indicators) e KQI (Key Quality...

  • Compliance & Quality System Manager

    3 settimane fa

    Ivrea, Italia Novartis A tempo pieno

    **Summary**: ~Gérer les activités, opérations et systèmes rentables de conformité GxP et/ou d’audit pour assurer la conformité des secteurs d’activité avec le manuel et les politiques de qualité de Novartis et toutes les exigences GxP, légales et réglementaires pertinentes, et par le biais d’audits internes, d’indicateurs clés de...

  • Compliance & Quality System Manager

    4 settimane fa

    Ivrea, Italia Novartis A tempo pieno

    **Summary**: ~İş alanlarının Novartis Kalite El Kitabı ve Politikaları ile ilgili tüm GxP, yasal ve düzenleyici gerekliliklere uygunluğunu sağlamak için ve iç denetimler, KPI'lar (Anahtar Performans Göstergeleri) ve KQI'ler (Anahtar Kalite Göstergeleri) yoluyla uygun maliyetli GxP Uyumluluğu ve/veya Denetim faaliyetlerini, operasyonlarını ve...

  • Compliance & Quality System Manager

    4 settimane fa

    Ivrea, Italia Novartis A tempo pieno

    **Summary**: ~ Gestionar las actividades, operaciones y sistemas rentables de cumplimiento y/o auditoría de GxP para garantizar el cumplimiento de las áreas de negocio con el Manual y las Políticas de Calidad de Novartis y todos los requisitos relevantes de GxP, legales y reglamentarios, y a través de auditorías internas, KPI (Indicadores clave de...

  • Compliance & Quality System Manager

    4 settimane fa

    Ivrea, Italia Novartis A tempo pieno

    **Summary**: ~費用対効果の高いGxPコンプライアンスおよび/または監査活動、運用、およびシステムを管理し、ノバルティス品質マニュアルおよびポリシー、および関連するすべてのGxP、法的および規制要件、および内部監査、KPI(主要業績評価指標)、KQI(主要品質指標)を...

  • Compliance & Quality System Manager

    4 settimane fa

    Ivrea, Italia Novartis A tempo pieno

    **Summary**: ~管理具有成本效益的 GxP 合规性和/或审核活动、运营和系统，以确保业务领域符合诺华质量手册和政策以及所有相关的 GxP、法律和法规要求，并通过内部审核、KPI（关键绩效指标）和...

  • Trd Quality Process

    3 settimane fa

    Ivrea, Italia Novartis A tempo pieno

    **Summary**: TRD Quality Process & Engineering Manager will collaborate with RLT Engineering organization for RLT TRD, to establish, maintain and improve the engineering processes with respect to buildings, equipment, utilities and energy. This role includes oversight of operational and validation activities and continuous process improvements. **About the...

  • Quality Manager

    4 settimane fa

    Ivrea, Italia CBS Lavoro Spa A tempo pieno

    CBS Lavoro S.p.a. Filiale di Santhià ricerca **QUALITY MANAGER **per azienda operante nel settore **progettazione e realizzazione di componentistica pneumatica**. **La risorsa si occuperà di**: - **Revisionare e redigere il piano qualità aziendali - Analisi delle esigenze del cliente - Definizione del livello standard di un prodotto e di un processo -...

  • Regulatory Compliance Expert

    6 giorni fa

    Ivrea, Piemonte, Italia Novartis ACC A tempo pieno

    Novartis ACC Career OpportunityWe are seeking a highly motivated QC Technician to join our team at Novartis ACC.Key Responsibilities:Perform quality control analysis on batches and incoming materials according to cGMP rules and SOPs.Report any deviations or out-of-specification results to the Quality Control Supervisor and Qualified Person.Collaborate with...

  • Trd Pilot Plant Quality Control Head

    1 settimana fa

    Ivrea, Italia Novartis A tempo pieno

    **Summary**: To lead the Ivrea TRD RLT Pilot plant Quality Control (QC) team by developing and executing strategic plans, providing direction for organizational structure, GMP and safety strategy, lean and continuous improvement initiatives, and people training and development. The QC Head is responsible for ensuring that the lab unit meets all agreed-upon...

  • TRD Pilot Plant Quality Control Head

    4 settimane fa

    Ivrea, Italia Novartis Farmacéutica A tempo pieno

    To lead the Ivrea TRD RLT Pilot plant Quality Control (QC) team by developing and executing strategic plans, providing direction for organizational structure, GMP and safety strategy, lean and continuous improvement initiatives, and people training and development. The QC Head is responsible for ensuring that the lab unit meets all agreed-upon objectives and...

  • TRD Pilot Plant Quality Control Head

    4 settimane fa

    Ivrea, Italia Novartis Farmacéutica A tempo pieno

    To lead the Ivrea TRD RLT Pilot plant Quality Control (QC) team by developing and executing strategic plans, providing direction for organizational structure, GMP and safety strategy, lean and continuous improvement initiatives, and people training and development. The QC Head is responsible for ensuring that the lab unit meets all agreed-upon objectives and...

  • Quality Control Technician

    1 settimana fa

    Ivrea, Italia GIGROUP A tempo pieno

    On behalf of a Multinational Pharmaceutical company, Gi Group LifeScience Division is looking for 3 Quality Control Technician Our client is an innovative medicines company focused on the development of products for targeted radioligand therapy and precision radioligand imaging. **Major Accountabilities**: Perform the analysis of batches following...

  • TRD Pilot Plant Quality Control Head

    3 settimane fa

    ivrea, Italia Novartis Farmacéutica A tempo pieno

    To lead the Ivrea TRD RLT Pilot plant Quality Control (QC) team by developing and executing strategic plans, providing direction for organizational structure, GMP and safety strategy, lean and continuous improvement initiatives, and people training and development. The QC Head is responsible for ensuring that the lab unit meets all agreed-upon objectives and...

  • TRD Pilot Plant Quality Control Head

    4 settimane fa

    Ivrea, Italia Novartis Farmacéutica A tempo pieno

    To lead the Ivrea TRD RLT Pilot plant Quality Control (QC) team by developing and executing strategic plans, providing direction for organizational structure, GMP and safety strategy, lean and continuous improvement initiatives, and people training and development. The QC Head is responsible for ensuring that the lab unit meets all agreed-upon objectives and...

  • Program Manager

    2 settimane fa

    Ivrea, Italia InnovHeart S.r.l. A tempo pieno

    At InnovHeart we are developing transcatheter mitral valve replacement (TMVR) systems to treat patients suffering from mitral valve disease. With a view to expanding the workforce and insourcing this role, we are looking for a Program manager who will be primarily responsible for the projects by integrating and coordinating the contributions of all the...

  • Laboratory Operations Manager

    1 settimana fa

    Ivrea, Piemonte, Italia Healthcare Businesswomen's Association A tempo pieno

    Job Title: QC Technician">Job Summary">The Healthcare Businesswomen's Association seeks a skilled QC Technician to execute laboratory tests, ensure compliance with regulatory requirements, and support the quality control department.">Key Responsibilities:">">Perform laboratory tests and analysis on batches and incoming materials according to cGMP rules and...

  • Operational Excellence Manager

    7 giorni fa

    Ivrea, Piemonte, Italia Novartis ACC A tempo pieno

    About Novartis ACC:We are a leading pharmaceutical company dedicated to improving and extending people's lives. Our purpose is to reimagine medicine to make a meaningful difference in the lives of patients and communities worldwide. We strive to create an inclusive work environment where diverse perspectives thrive, and our associates are empowered to drive...