QA Systems Manager (m/f/d)

unisite ag is a service provider in the field of Employer Branding & Talent Management. We provide consulting services to clients in the chemistry, pharmaceutical, biotech, medical device, and life sciences industries.

Our client, Pentapharm AG, is a Swiss SME with a long-standing tradition as an innovative and reliable supplier of active ingredients for the personal care, pharmaceutical and haemostasis diagnostics industries.

On behalf of our client, we are currently looking for a:

QA Systems Manager (m/f/d)

Location: Aesch, BL

Position

For the Quality Assurance team, we are looking for an experienced and hands-on QA Systems Manager (m/f/d) to ensure the effective operation and continuous compliance of our Quality Management System.

In this role, you will take ownership of key QA systems and processes, including eQMS and training management, Quality Agreements, complaints and Product Quality Reviews. You will work closely with internal stakeholders and external partners to ensure compliance with applicable GMP/GDP requirements.

Tasks

Administer and maintain the electronic Quality Management System (eQMS) and electronic training management system, including document control, user access, training records and related QA system activities
Support onboarding and offboarding activities related to training assignments and eQMS access
Coordinate Quality Agreements with customers and suppliers, including preparation, review, approval and periodic updates
Coordinate the maintenance and periodic review of 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 related CAPA activities
Support Change Control assessments as the Quality representative
Prepare and review QA-related sections of customer quality questionnaires
Support customer audits and regulatory inspections, including preparation, back-office coordination and follow-up of observations
Ensure QA systems and documentation remain compliant with applicable GMP/GDP requirements and data integrity principles

Qualification

MSc in Biology, Chemistry, Pharmacy, Quality Management or a related scientific field
Strong track record and extensive hands-on experience in a GMP- or ISO-regulated production environment
Strong knowledge of GMP requirements and Quality Management Systems
Practical experience with eQMS and electronic document management systems
Sound knowledge of key quality processes, including complaints, CAPA, Change Control, training management and audits
Familiarity with pharmaceutical quality standards and regulatory requirements; basic knowledge of IVDR is an advantage
Strong organizational skills and a structured, detail-oriented approach to work
Ability to work independently, take ownership and collaborate effectively across functions
Very good communication skills in German and English
Confident user of common IT systems and digital quality tools

Seize this opportunity to shape your future - we look forward to receiving your application!