Quality Management Specialist

il y a 15 heures

Paris, Île-de-France Meet Life Sciences Temps plein

An innovative, clinical-stage biotechnology organization focused on developing gene- and cell-based therapies for serious diseases is seeking an experienced
QMS Manager
. This role offers the opportunity to play a pivotal part in strengthening and evolving the Quality Management System within a highly regulated, cutting-edge biotech environment.

The QMS Manager will be responsible for overseeing, maintaining, and continuously improving the Quality Management System to ensure compliance with global regulatory requirements. The role will work closely with R&D, Clinical, Manufacturing, Regulatory Affairs, and external partners to support development and commercialization activities.

Key Responsibilities

  • Own and manage the Quality Management System in compliance with applicable regulations and standards (e.g. GMP, GxP, ISO standards).
  • Develop, implement, and maintain quality policies, procedures, and controlled documentation.
  • Manage QMS processes including deviations, CAPAs, change control, risk management, and training.
  • Lead internal audits and support health authority and partner audits and inspections.
  • Oversee document control systems and ensure training compliance across the organization.
  • Ensure effective quality oversight of external vendors, CMOs, and partners.
  • Monitor quality performance metrics and report QMS status to senior management.
  • Promote a culture of quality, compliance, and continuous improvement across the company.

Required Experience & Qualifications

  • Bachelor's degree in Life Sciences, Biotechnology, Pharmacy, or a related discipline.
  • Significant experience managing a QMS within a biotech, pharmaceutical, or advanced therapy environment.
  • Strong knowledge of GMP, GxP, and relevant international regulatory requirements.
  • Proven experience supporting regulatory inspections and audits.
  • Hands-on experience with electronic QMS (eQMS) platforms.
  • Excellent organizational, communication, and stakeholder management skills.

Desirable Experience

  • Experience in gene therapy, cell therapy, or advanced therapy medicinal products (ATMPs).
  • Experience working in a clinical-stage or growing biotech company.
  • Auditor or Lead Auditor qualification

  • Supplier Quality Specialist

    il y a 1 semaine

    Paris, Île-de-France Danfoss Temps plein

    The Impact You'll MakeSemikron Danfoss is a global leader in power electronics and energy solutions. We focus on providing sustainable and innovative technologies for sectors like energy, automotive, industrial automation, and more. As we expand our operations and continue our legacy of excellence.As aSupplier Quality Specialist at Semikron Danfoss, you will...

  • Quality Manager

    il y a 6 jours

    Paris, Île-de-France Underpants Temps plein

    Quality ManagerJob descriptionQuality managers aim to ensure that the product or service an organisation provides is fit for purpose, is consistent and meets both external and internal requirements. This includes legal compliance and customer expectations. A quality manager, sometimes called a quality assurance manager, coordinates the activities required to...

  • Quality Assurance Manager

    il y a 1 semaine

    Paris, Île-de-France Leap29 Temps plein

    Our client, a leading global data centre developer, is seeking an experienced Quality Manager to join a flagship hyperscale data centre project in Paris. This is a long-term consultancy contract (12 months, renewable) working on one of Europe's most technically advanced facilities.Role OverviewAs Quality Manager, you will oversee and maintain all quality...

  • Quality Manager

    il y a 1 semaine

    Paris, Île-de-France Sealed Air Temps plein

    Sealed Air designs and delivers packaging solutions that protect essential goods transported worldwide, preserve food, enable e-commerce and digital connectivity, and help create a global supply chain that is touchless, safer, less wasteful, and more resilient. We strive to foster a caring, high-performance growth culture that will deliver consistent,...

  • Remote Quality Manager

    il y a 3 jours

    Paris, Île-de-France Jobgether Temps plein

    This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Remote Quality Manager - REMOTE. In this role, you will lead a quality team focused on ensuring the highest standards across various stations. Your expertise will drive subcontractor quality and facilitate audits and reviews that promote operational...

  • Project Business Quality Manager

    il y a 1 semaine

    Paris, Île-de-France Hager Group Temps plein

    Why Join the High Current Project Business?Our High Current Project Business represents a brand-new, strategic business area that Hager Group is diving into to meet growing demand. This role offers a unique chance to shape the future of quality standards in high-current power distribution solutions. Joining this team means becoming part of an innovative...

  • Plant Quality Manager France

    il y a 6 jours

    Paris, Île-de-France Orbia Temps plein

    Join us at Orbia Building & Infrastructure (Wavin): Where purpose comes to life.You are purpose driven. Growth minded. Ready to stretch your potential. Welcome to Orbia's Building & Infrastructure business, Wavin, where our purpose 'to advance life around the world' drives our entire global team.Every day, we are thinking big and working smart to solve some...

  • Data Quality Specialist, AI Tutor

    il y a 6 jours

    Paris, Île-de-France Mistral AI Temps plein

    About Mistral At Mistral AI, we believe in the power of AI to simplify tasks, save time, and enhance learning and creativity. Our technology is designed to integrate seamlessly into daily working life. We democratize AI through high-performance, optimized, open-source and cutting-edge models, products and solutions. Our comprehensive AI platform is...

  • Data Quality Manager

    il y a 3 jours

    Paris, Île-de-France VISIAN Temps plein

    À propos du rôleLa mission du Data Office s'est fortement enrichie avec la promotion de l'utilisation de la DATA par l'ensemble des projets des Métiers / Fonctions (Risque/Finance/ IT) de l'organisation et du Groupe. L'objectif est de développer l'activité commerciale, de diminuer les couts, d'améliorer l'efficacité opérationnelle et de répondre à...

  • Data Quality Manager

    il y a 3 jours

    Paris, Île-de-France Collective Temps plein

    Budget: 730À propos du rôleLa mission du Data Office s'est fortement enrichie avec la promotion de l'utilisation de la DATA par l'ensemble des projets des Métiers / Fonctions (Risque/Finance/ IT) de l'organisation et du Groupe. L'objectif est de développer l'activité commerciale, de diminuer les couts, d'améliorer l'efficacité opérationnelle et de...