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Quality Affairs Manager – Pharmaceutical Distribution (Neuchâtel)

GALSER SA · Neuchâtel

Onsite Senior 🇬🇧 English
Good Distribution Practice (GDP) Quality Management System (QMS) change control quality risk assessment

Description du poste

About the role

We are looking for an experienced Quality Affairs Manager to lead all quality activities related to the distribution and commercialization of medicinal products in Switzerland. The role will own the Quality Management System, ensure compliance with Good Distribution Practice, and act as the main quality liaison with manufacturers, logistics providers and regulators.

Key responsibilities

  • Provide quality oversight of pharmaceutical distribution and ensure compliance with Swiss therapeutic products legislation and GDP requirements.
  • Approve batch releases for distribution in Switzerland and maintain the QMS.
  • Draft, review and maintain SOPs, work instructions, policies and other controlled quality documents.
  • Establish and manage Quality and Technical Agreements with external partners (manufacturers, 3PLs, suppliers).
  • Qualify, monitor and audit suppliers and service providers involved in GDP activities.
  • Manage deviations, CAPAs, change controls, quality risk assessments and ensure timely investigations and follow‑up.
  • Handle product quality complaints, returns, recalls and other distribution‑related quality events.
  • Plan and conduct internal audits, coordinate external audits and inspections by Swissmedic and other authorities.

Required profile

  • Strong hands‑on experience with pharmaceutical GDP and quality systems in Switzerland.
  • Proven ability to work autonomously and lead cross‑functional quality initiatives.
  • Fluent in English (C1) and either French or German (C1).
  • Excellent knowledge of Swiss therapeutic products legislation and regulatory expectations.

Required skills

  • Good Distribution Practice (GDP)
  • Quality Management System (QMS) implementation and maintenance
  • CAPA and deviation management
  • Audit planning and execution
  • Change control processes
  • Quality risk assessment methodologies

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GALSER SA

Neuchâtel