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Director Quality Assurance & Production Management

Employeur non precise

New
Senior 🇬🇧 English
GMP GDP ISO 13485 Quality Management System (QMS) CAPA Change control Technology transfer

Job description

About the role

An established Swiss pharmaceutical company with an international presence, specialising in prescription and OTC products in gynecology, dermatology and phlebology, is looking for an experienced leader to take full ownership of Quality Assurance and Production Management. The role is based in Switzerland and covers the company's global manufacturing network, which needs robust quality standards, efficient production processes and close collaboration with external partners.

Key responsibilities

  • Lead global Quality Assurance and Production Management, overseeing international teams, resource planning, budgets, KPIs and operational performance.
  • Define and implement global quality and compliance strategies, ensuring adherence to GMP, GDP, ISO 13485 and regulatory requirements.
  • Oversee and continuously improve the Quality Management System (QMS), including deviations, CAPAs, change control, audits, risk management and quality investigations.
  • Manage external manufacturing partners and CDMOs, ensuring supplier qualification, quality agreements, manufacturing compliance and operational excellence.
  • Drive technology transfers, manufacturing transfers, process optimisation, validations and the integration of new products and production partners.
  • Lead regulatory inspections, continuous improvement initiatives and manufacturing expansion activities.

Required profile

  • Degree in Pharmacy, Life Sciences, Chemistry or a related scientific discipline.
  • Extensive leadership experience combining pharmaceutical production operations and Quality Assurance in regulated manufacturing environments.
  • Strong hands-on manufacturing background, including production processes, operational management and international manufacturing networks.
  • Proven experience managing CDMOs, external manufacturing partners, technology transfers and complex quality and compliance processes.
  • Fluency in German and English, strong international leadership capabilities and willingness to travel about 50% across European sites.

Required skills

  • Strong knowledge of GMP, GDP, ISO 13485 and QMS requirements.
  • Qualified Person (QP) certification or relevant Deputy QP experience is highly desirable.

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Published 2 hours ago

Expires 1 month from now

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Employeur non precise