Site Quality Head, DS Huningue

il y a 2 semaines

Huningue, Grand Est, France Novartis Temps plein

Band

Level 7

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.

Job Description

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.

Skills Desired

  • Site Quality Head, DS Huningue

    il y a 2 semaines

    Huningue, Grand Est, France Novartis Temps plein

    Job 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...

  • TECHNICIEN Multitechnique posté F/H

    il y a 3 jours

    Huningue, Grand Est, France Groupe Bouygues Temps plein

    Informations générales Référence Equans_76955   Date de parution /12/2025 Filière MétierRéf métier Bouygues SA - TRAVAUX Intitulé du posteTECHNICIEN Multitechnique posté F/H ContratCDI Temps de travailTemps complet Description de la missionAxima Maintenance Technique et Bouygues Energies & Services FM unissent leurs forces au sein d'une...

  • AS&T Analyst

    il y a 6 jours

    Huningue, Grand Est, France Novartis Temps plein

    SummaryAS&T Analyst (CDI), Huningue, France L'Analyst AS&T sera responsable de l'exécution des tâches assignées dans le laboratoire AS&T conformément aux réglementations GxP. Il / Elle se focalisera sur la performance des activités spécifiques au laboratoire telles que les analyses, et la validation de méthodes analytiques. En outre, il / elle...

  • TECHNICIEN Multitechnique posté F/H

    il y a 2 semaines

    Huningue, Grand Est, France Equans Temps plein

    Description de l'emploiAxima Maintenance Technique et Bouygues Energies & Services FM unissent leurs forces au sein d'une marque unique : Equans Services Bâtiments & Infrastructures Avec plus de 80 implantations en France, les équipes d'Equans Services Bâtiments & Infrastructures accompagnent leurs clients dans les domaines du Facility Management, de la...

  • Shift lead QC

    il y a 1 jour

    Huningue, Grand Est, France Novartis Temps plein

    SummaryResponsable d'Équipe CQ / Shift Lead QC (H/F), Huningue, France A propos du poste: En tant que Responsable d'Équipe, vous jouerez un rôle clé dans la bonne conduite des opérations de Contrôle Qualité, en veillant au respect des plannings et à la conformité aux exigences HSE et BPF. Vous serez garant de la mise à disposition des...

  • QC Analyst

    il y a 5 jours

    Huningue, Grand Est, France Novartis Temps plein

    Job Description SummaryQC Analyst (h/f), Huningue, FranceA propos du poste:Nous recherchons un(e) Technicien(ne) de laboratoire en Contrôle Qualité en CDD, travaillant en rythme 5x8, qui sera responsable de réaliser des analyses sur les échantillons au sein du département. Si vous apportez une expérience en laboratoire ainsi qu'une qualification en...

  • Technicien CQ 1

    il y a 2 semaines

    Huningue, Grand Est, France Novartis Temps plein

    SummaryQC Analyst 1 (h/f), Huningue, France A propos du poste: Nous recherchons un(e) Technicien(ne) de laboratoire en Contrôle Qualité en CDI qui sera responsable de la gestion et la coordination des interventions sur les équipements au sein du département QC. Si vous apportez une expérience à la vie du laboratoire ainsi qu'une qualification en Bac...

  • Candidatures spontanées H/F

    il y a 1 semaine

    Huningue, Grand Est, France Elanco Temps plein

    At Elanco (NYSE: ELAN) – it all starts with animalsAs a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers,...

  • QC Analyst

    il y a 5 jours

    Huningue, Grand Est, France Novartis Temps plein

    BandLevel 1Job Description SummaryQC Analyst (h/f), Huningue, FranceA propos du poste:Nous recherchons un(e) Technicien(ne) de laboratoire en Contrôle Qualité en CDD, travaillant en rythme 5x8, qui sera responsable de réaliser des analyses sur les échantillons au sein du département. Si vous apportez une expérience en laboratoire ainsi qu'une...

  • QC Analyst

    il y a 5 jours

    Huningue, Grand Est, France Novartis Temps plein

    Job Description SummaryQC Analyst (h/f), Huningue, FranceA propos du poste:Nous recherchons un(e) Technicien(ne) de laboratoire en Contrôle Qualité en CDD, travaillant en rythme 5x8, qui sera responsable de réaliser des analyses sur les échantillons au sein du département. Si vous apportez une expérience en laboratoire ainsi qu'une qualification en...