Manager Quality Assurance, System
hace 3 semanas
**Summary**:The Manager, Quality Assurance role leads the overall Quality Assurance activities for Novartis Patient Support (NPS) patient support programs in designing and monitoring Quality management systems such as training and audits that will optimize compliance to Novartis requirements and applicable GxP regulations.**About the Role**:**Major accountabilities**:- Ensure the Quality principles, policies and procedures that foster a knowledgeable and compliant organization are engrained in routine activities of the Novartis Patient Support organization.- Ensure quality KPIs are quantifiable with success metrics.- Identify, develop and implement training system that addresses Quality and Compliance policies and requirements relevant to specific roles within each NPS function.- Continuously evaluate, to identify opportunities in area of Quality/Compliance systems and standards including remedial action plans and tracks resolution.- Periodic monitoring of internal hub and external vendors systems and processes to ensure compliance.- Manage NPS audit & assessment programs- Prepare periodic metric report for NPS management and highlight any areas for improvement as needed.- Liaise with Drug Safety, Country Quality, Patient Oriented Programs (POP) owners, Legal, Privacy and Compliance- Responsible for ensuring compliance with pharmacovigilance requirements such as Adverse Event source data verification- NPS advocate in Country Quality risk assessment process and global procedure applicability review**Key performance indicators**:- Ensure established processes are being followed- Continuous improvement trend in agreed upon metrics for NPS- Ensure quality KPIs are quantifiable with success metrics**Minimum Requirements**:**Work Experience**:- Professional experience in the field of Quality Assurance or related activities- 5+ years of relevant experience within a regulated area of the pharmaceutical industry- Ability to identify opportunities for continued improvements and drive their implementations across the organization.- Knowledgeable on effective Quality documentation systems and training practices- Good communication & negotiation skills- Experience in project management, planning and organization, and audits.- Ability to work effectively as an individual contributor and in a team structure; maintain strong cross-functional ties with key business partners.- Good collaboration, communication and team facilitation skills- Mastery of English, oral and written- Willingness to travel, sometimes at short notice; travel time up to 10%**Skills**:- Pharmaceutical Regulations- Continuous Learning.- Able to effectively communicate with cross-functional teams and across boundries- Dealing With Ambiguity.- QA (Quality Assurance).- Quality Management- Pharmacovigilance (adverse event reporting requirements)- Risk Management.- Self Awareness.- Technological Expertise.**Languages**:- English.DivisionUSBusiness 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.
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Quality Assurance Analyst
hace 2 semanas
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Quality Assurance Analyst
hace 2 semanas
Insurgentes, México Novartis A tiempo completo**Summary**: - Supports 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). -Supports the...
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Quality Management System Sr Specialist
hace 3 semanas
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Quality Assurance Analyst
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Insurgentes, México Novartis A tiempo completo**Summary**:~ Prend en charge des activités, des opérations et des systèmes efficaces 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, ainsi que par le biais d’audits internes,...
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Quality Assurance Analyst
hace 2 semanas
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Insurgentes, México Novartis A tiempo completo**Summary**:~Unterstützt effektive GxP-Compliance- und/oder Audit-Aktivitäten, -Abläufe und -Systeme, um die Einhaltung des Novartis-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)...
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hace 3 semanas
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Quality Assurance Analyst
hace 2 semanas
Insurgentes, México Novartis A tiempo completo**Summary**: ~Ondersteunt effectieve GxP Compliance en/of Audit activiteiten, operaties en systemen om ervoor te zorgen dat bedrijfsonderdelen voldoen aan de Novartis Quality Manual and Policies en alle relevante GxP, wet - en regelgeving, en door middel van interne audits, KPI's (Key Performance Indicators) en KQIs (Key Quality Indicators). ~Ondersteunt de...
