QASystems Manager(m/f/d)

unisite ag; Aesch; Vor Ort; Vertraulich; Vollzeit

Zusammenfassung

unisite ag in Basel-Landschaft, Aesch, is seeking a hands-on QA Systems Manager to own and continuously improve the QA systems landscape, including eQMS, training management, and quality agreements. You will collaborate with internal teams and external partners to ensure GMP/GDP compliance and data integrity.

The role requires a MSc in a relevant field and 10+ years in GMP/ISO environments, with strong German and English communication skills and proven eQMS experience.

Qualifikationen

• 10+ years of professional experience in a GMP- or ISO-regulated environment.
• 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 a plus.
• Excellent organizational skills and an analytical, detail-oriented approach.
• Ability to work independently and collaborate across functions.
• Very good German and English communication skills.

Aufgaben

• Administer and maintain the eQMS and training management systems, including document control and access management.
• Coordinate Quality Agreements with customers and suppliers, including reviews and updates.
• Coordinate Site Master File maintenance and annual Product Quality Reviews (PQRs).
• Manage customer complaints and drive investigations and CAPA activities.
• Support Change Control assessments as QA representative.
• Prepare QA sections of customer quality questionnaires and support audits/inspections.
• Ensure ongoing GMP/GDP compliance and data integrity across QA systems.

Kenntnisse

GMP knowledge

Quality Management Systems

eQMS experience

Documentation control

Regulatory inspections

Cross-functional collaboration

Ausbildung

MSc in Biology/Chemistry/Pharmacy

Tools

eQMS software

Electronic document management

Quality questionnaires

Jobbeschreibung

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
• 10+ years of professional 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