Site Quality Head, DS Huningue
il y a 22 heures
Job Description Summary The Site Quality Head is responsible to provide managerial leadership for the site in all quality related matters and to ensure that key aspects of the operational business comply with cGMP and regulatory requirements as well as the key Novartis corporate quality policies. The Site Quality Head develops and leads the quality teams at the site in line with the Novartis leadership framework and cultural aspirations. Major accountabilities Lead the Site Quality organization, ensuring quality oversight of all GxP functions and acting as the site Technical Responsible Person (Qualified Person). Ensure product quality, regulatory compliance, and implementation of corporate quality standards, including maintenance of local HA registrations and preparation of the Site Master File. Govern and comply with the Novartis Manufacturing Manual, manage site quality risk assessments, and conduct Quality Management Reviews. Approve or reject raw materials, facilities, utilities, intermediates, finished products, stability samples, and PQR/APQR, while overseeing exception and complaint management. Ensure effective training execution, data integrity, eCompliance, and adherence to all cGxP, HSE guidelines, and local legal requirements, including business continuity management and collaboration with 3rd parties under appropriate Quality Agreements. Drive the talent agenda by recruiting, training, coaching, developing succession plans, promoting talent exchange, and fostering a high-engagement culture aligned with Curious, Inspired, and Un-bossed behaviors. Promote and improve Safety and Quality cultures, ensure inspection readiness, support crisis management and Business Continuity Plans, and oversee HSE incident reporting and follow-up. Ensure the quality management system conforms to ISO 9001, that processes deliver intended outputs, report performance and improvement opportunities to top management, promote customer focus, and maintain QMS integrity during changes. Obligatory requirements Education : University degree in Pharmacy, Engineering, Chemistry, Biotechnology or equivalent. 12-15 years’ experience in the field of Quality Assurance and Quality Control in a pharmaceutical industry environment or equivalent. Strong technical knowledge in Drug Substance Manufacturing Operations Management and Execution. Solid stakeholder management - especially with labor unions and Health authorities. Knowledge of GMP Quality Control (QC) Testing, Manufacturing Process/Product Expertise. Fluent English and French (oral and written). Desirable Requirements Additional specialist experience in QC is preferred. You’ll receive Annual bonus Focus on career development Quality of Work Life approach allowing you to propose improvements for your daily life Emphasis on work-life balance with arrangements such as telecommuting, reduced annual working hours, or parental leave Advanced social coverage for you and your loved ones 27 paid vacation days and at least 14 JDR (days off) days per year Various employee recognition programs Commitment to Diversity and Inclusion / EEO Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. #J-18808-Ljbffr
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Site Quality Head, DS Huningue
il y a 1 semaine
Huningue, Grand Est, France Novartis Temps pleinBandLevel 7Job Description SummaryThe Site Quality Head is responsible to provide managerial leadership for the site in all quality related matters and to ensure that key aspects of the operational business comply with cGMP and regulatory requirements as well as the key Novartis corporate quality policies. The Site Quality Head develops and leads the quality...
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Site Quality Head, DS Huningue
il y a 1 semaine
Huningue, Grand Est, France Novartis Temps pleinJob Description SummaryThe Site Quality Head is responsible to provide managerial leadership for the site in all quality related matters and to ensure that key aspects of the operational business comply with cGMP and regulatory requirements as well as the key Novartis corporate quality policies. The Site Quality Head develops and leads the quality teams at...
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Site Quality Head: GxP Excellence
il y a 1 jour
Huningue, France Healthcare Businesswomen’s Association Temps pleinA leading healthcare organization in Huningue is seeking a Site Quality Head responsible for managerial leadership in quality matters, ensuring compliance with regulatory requirements and corporate quality policies. The ideal candidate will have 12-15 years of experience in Quality Assurance, a relevant university degree, and fluency in English and French....
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Assistant Administratif Et Financier Service évènementiel Et Commerces
il y a 2 semaines
Huningue, France Mairie de Huningue Temps plein**Huningue c’est** Une ville située sur le Rhin face à l’Allemagne et voisine de Bâle. Réputée pour son Parc des Eaux Vives, HUNINGUE compte aujourd’hui 7500 habitants dans un cadre dynamique offrant à la fois des emplois, des aménagements urbanistiques et de loisirs et de nombreux services à la population. La ville est reconnue pour son...
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Site Engineering Head
il y a 3 jours
Huningue, France Novartis Farmacéutica Temps pleinWe are seeking a Site Engineering Head to lead the site engineering and maintenance organization, consisting of approximately 120 internal individuals, as well as external contractors / partners. The main role of the Site Engineering Head is to ensure that the engineering department establishes, executes, maintains, and enhances the engineering procedures in...
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Quality Manager
il y a 5 jours
Huningue, France VIGS Temps pleinDescription de l'entreprise Le **groupe Veolia** a pour ambition de devenir l’entreprise de référence de la transformation écologique. Présent sur les cinq continents avec près de 179 000 salariés, le Groupe conçoit et déploie des solutions utiles et concrètes pour la gestion de l’eau, des déchets et de l’énergie qui participent à changer...
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Quality Manager
il y a 5 jours
Huningue, France VIGS Temps plein**Description de l'entreprise**: Le **groupe Veolia** a pour ambition de devenir l’entreprise de référence de la transformation écologique. Présent sur les cinq continents avec près de 179 000 salariés, le Groupe conçoit et déploie des solutions utiles et concrètes pour la gestion de l’eau, des déchets et de l’énergie qui participent à...
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Biomedical Data Engineer
il y a 5 jours
Huningue, France FIRALIS GROUP Temps pleinFiralis is a biotechnology company with a mission to improve disease outcomes, therapeutic decisions and generate savings in healthcare through biomarker discovery, development and regulatory qualification ultimately leading to biomarker-based diagnostics. With a strong expertise and an extreme quality environment (ISO 9001, ISO 13845, ISO 17025 and NF S...
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Expert Aq Operationnelle
il y a 1 semaine
Huningue, France Novartis Temps plein391756BR **Expert AQ Operationnelle**: France **À propos du rôle** Localisation : Huningue #LI-Présentiel A propos du poste: Nous recherchons un(e) **Expert AQ Opérationnelle**, qui sera responsable de la mise en place et du maintien des opérations du site à un niveau qualité en conformité avec les Bonnes Pratiques de Fabrication, les...
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QA Operations Manager and Project Lead
il y a 5 jours
Huningue, France Novartis Temps plein393901BR **QA Operations Manager and Project Lead**: France **À propos du rôle** Localisation : Huningue #LI-Hybride **A propos du poste**: Nous recherchons un(e) **QA Operations Manager and Project Lead**, qui sera responsable de la stratégie de l’unité QA/QC à moyen et long terme, que la stratégie soit enlignée avec les objectifs de...
