Job Details

Senior Quality Assurance Manager

5922
  • £Competitive
  • Basel, - None Specified -
  • Permanent

A global pharmaceutical company is looking to hire a Senior Quality Assurance Manager on a permanent basis. Working from their site in Zug, the successful candidate will play a key role in ensuring regulatory compliance and product quality across several Swiss legal entities.

Role Responsibilities:

  • Acting as Deputy QP (FvP), including batch disposition, recalls, and ensuring GDP compliant distribution
  • Leading and maintaining the local Quality Management System (QMS) in line with GMP/GDP standards
  • Serving as primary quality contact for Swissmedic, cantonal authorities, and external partners
  • Conducting management reviews, self-inspections, and release of reworked batches/products
  • Acting as Person Responsible for Regulatory Compliance (PRRC) under the Swiss Medical Devices Ordinance
  • Managing responsibilities related to narcotics and controlled substances according to Swiss regulations
  • Handling deviations, complaints, CAPA activities, and product recalls
  • Approving and maintaining quality-relevant documentation (SOPs, PQRs, Technical Quality Agreements)
  • Supporting supplier qualification and overseeing training activities

Required Skills & Experience:

  • University degree in pharmacy or a scientific discipline (e.g., chemistry, biology)
  • 8+ years of experience in the pharmaceutical industry, including minimum 5 years in Quality Assurance
  • Proven experience as Swiss QP (FvP) or Deputy QP (minimum 3 years)
  • In-depth knowledge of regulatory requirements (TPA, MPLO, GDP, GMP, BetmG)
  • Strong decision-making and communication skills, able to act independently and responsibly
  • Fluency in English and German (spoken and written); French is a plus
  • Experience in liaising with Swissmedic and international regulatory authorities is an advantage

This role is open to EU/EFTA citizens or those who hold a valid Swiss Work Permit.

For additional information, and a confidential discussion, please apply now with an updated CV.

Trish Kelly Principal Consultant in Clinical Data Management & Clinical Research

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