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Quality & Regulatory Affairs Manager (Part-time 20 hours per week)

Resourcify · Hamburg, Germany

External listingpart-time28 days ago

About The Role

Join Resourcify as a part-time Quality & Regulatory Affairs Manager. In this role, you will build and own the quality and compliance foundation that enables the company to scale across EMEA and the US. You will be responsible for compliance and internal quality assurance, consulting with the Solutions team during the conception of new markets, and taking full ownership within Operations. This position offers flexible working hours, remote work, and opportunities for learning and development.

  • Construire, mettre en œuvre et améliorer continuellement notre système de gestion de la qualité (SGQ), y compris les procédures opérationnelles standard (SOP), la documentation des processus et les normes de contrôle des documents.
  • Planifier et réaliser des audits internes de nos processus opérationnels, en conduisant des actions correctives et préventives pour garantir que nous respectons constamment nos propres normes.
  • Consulter notre équipe Solutions lors de la conception de nouveaux marchés et de la mise en place de partenaires, en aidant à façonner les exigences de conformité dès le départ.
  • You enjoy bringing structure to complex operational processes and continuously improving them
  • You are confident creating and maintaining SOPs, process documentation, and document control systems
  • You take ownership, work independently, and have a hands-on, execution-oriented mindset
  • You have experience building or managing Quality Management Systems
  • You are fluent in English; German is a strong plus
  • You have experience conducting or managing supplier and third-party audits
  • You communicate confidently across teams and can collaborate effectively with both internal and external stakeholders
  • Experience working in pharma, med-tech, or another highly regulated industry
  • Experience with certification bodies, enterprise customer audits, or insurer compliance requirements (e.g. ISO 9001 and/or ISO 14001)
  • Knowledge of sustainability, recycling, waste management, or circular economy topics
  • Experience working in a fast-growing startup or scale-up

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