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Quality Manager – Sterile Manufacturing

gloor & lang Pharma and Biotech Recruiting · Soleure

🇬🇧 English
GMP CAPA Change Control

Job description

About the role

We are seeking a Quality Manager to lead quality and compliance activities at our specialized sterile pharmaceutical manufacturing site in French‑speaking Switzerland. The role works closely with Production, QA, QC and the Qualified Person to ensure GMP compliance and drive continuous improvement in a highly regulated environment.

Key responsibilities

  • Support batch review and release, ensuring all documentation meets GMP standards.
  • Review GMP documentation and manufacturing records for accuracy and completeness.
  • Manage deviations, CAPAs and Change Controls from investigation through closure.
  • Provide day‑to‑day quality support to production, laboratories and warehouse operations.
  • Maintain a strong shop‑floor presence, promoting continuous improvement initiatives.
  • Act as the primary compliance contact for customers and external partners.
  • Assist with inspections, client audits and regulatory interactions.

Required profile

  • Degree in Pharmacy, Chemistry, Life Sciences or Engineering.
  • Proven experience in GMP‑regulated pharmaceutical manufacturing.
  • Strong exposure to sterile/aseptic production processes.
  • Hands‑on experience with deviations, investigations and change control procedures.
  • Operational mindset with willingness to work close to production.
  • Fluent French and good English communication skills.

Required skills

  • Good Manufacturing Practice (GMP) knowledge.
  • Aseptic/sterile manufacturing expertise.
  • Quality Management System (QMS) operation.
  • Deviation and CAPA management.
  • Change Control processes.

What we offer

  • High visibility role within a specialized pharmaceutical site.
  • Broad quality responsibilities with direct impact on operations.
  • Close collaboration with Production, QA, QC and Release teams.
  • International environment with short decision paths.
  • Opportunity to develop towards broader Quality and Qualified Person responsibilities.

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Published 2 months ago

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gloor & lang Pharma and Biotech Recruiting

Soleure