Quality Systems Manager – eQMS & GMP Expert

Pentapharm

Aesch

On-site

CHF 150,000 - 210,000

Full time

3 days ago
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Job summary

Pentapharm AG in Basel-Landschaft is seeking an experienced QA Systems Manager (m/f/d) to ensure the effective operation and continuous compliance of the Quality Management System, including eQMS and training management.

You will own Quality Agreements, handle complaints and CAPA, coordinate Change Control, audits and regulatory inspections, and work closely with internal stakeholders and external partners to ensure GMP/GDP compliance and data integrity.

Qualifications

  • 10+ years of professional experience in GMP- or ISO-regulated production environments.
  • Strong knowledge of GMP requirements and Quality Management Systems.
  • Practical experience with eQMS and electronic document management systems.
  • Familiarity with pharmaceutical quality standards and regulatory requirements; IVDR knowledge is advantageous.

Responsibilities

  • Administer and maintain the eQMS and training management system, including document control and access management.
  • Coordinate Quality Agreements with customers and suppliers, including reviews and updates.
  • Lead annual Product Quality Reviews (PQRs) with cross-functional data collection.
  • Manage customer complaints and coordinate investigations and CAPA activities.
  • Support Change Control as Quality representative and assist audits/inspections.

Skills

GMP knowledge
Quality Management
Documentation control
Stakeholder collaboration
Regulatory awareness
German & English communication

Education

MSc in Biology, Chemistry, Pharmacy, Quality Management or related field

Tools

eQMS software
Electronic document management

Job description

Pentapharm AG in Basel-Landschaft is seeking an experienced QA Systems Manager (m/f/d) to ensure the effective operation and continuous compliance of the Quality Management System, including eQMS and training management.

You will own Quality Agreements, handle complaints and CAPA, coordinate Change Control, audits and regulatory inspections, and work closely with internal stakeholders and external partners to ensure GMP/GDP compliance and data integrity.

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