QA Systems Manager (m/f/d)

About the role

On behalf of its client Pentapharm AG, a Swiss SME supplying active ingredients for personal care, pharmaceutical and haemostasis diagnostics, unisite ag is looking for an experienced, hands-on QA Systems Manager (m/f/d) for the Quality Assurance team in Aesch, BL. The role ensures the effective operation and continuous compliance of the Quality Management System, covering eQMS, training management, Quality Agreements, complaints and Product Quality Reviews, in close cooperation with internal stakeholders and external partners.

Key responsibilities

• Administer and maintain the electronic Quality Management System (eQMS) and electronic training management system, including document control, user access, training records and related QA activities
• Support onboarding and offboarding related to training assignments and eQMS access
• Coordinate Quality Agreements with customers and suppliers, including preparation, review, approval and periodic updates
• Maintain and periodically review the Site Master File
• Initiate and coordinate annual Product Quality Reviews (PQRs), including cross-functional data collection and follow-up
• Manage customer complaints and coordinate investigations and CAPA activities
• Support Change Control assessments as the Quality representative
• Prepare and review QA sections of customer quality questionnaires
• Support customer audits and regulatory inspections, including preparation, back-office coordination and follow-up of observations
• Keep QA systems and documentation compliant with GMP/GDP requirements and data integrity principles

Required profile

• MSc in Biology, Chemistry, Pharmacy, Quality Management or a related scientific field
• 10+ years of professional experience in a GMP- or ISO-regulated production environment
• Familiarity with pharmaceutical quality standards and regulatory requirements; basic knowledge of IVDR is an advantage
• Very good communication skills in German and English
• Ability to work independently, take ownership and collaborate across functions

Required skills

• Strong knowledge of GMP requirements and Quality Management Systems
• Practical experience with eQMS and electronic document management systems
• Knowledge of complaints, CAPA, Change Control, training management and audits
• Structured, detail-oriented approach and confident use of common IT systems and digital quality tools