For one of our clients, a global pioneer in pharmaceuticals, we are currently looking for a Quality Assurance Manager (Manufacturing Unit Monoclonal Antibodies).
General Information
* Duration: until 09.2026 with the possibility of extension
* Workplace: Basel
* Working hours: Standard
* Team: 6 people
About the job
The Basel Drug Substance division at the group headquarters in Basel is divided into various production units for monoclonal antibodies (MAB), Single-Use Technology (SUT), Antibody Drug Conjugates (ADC) and additionally Synthetic Molecules (SM). Within this dynamic environment, the Quality Assurance (QA) team ensures compliance with the highest quality standards and drives the continuous improvement of our processes. Organizationally, the QA Managers belong to one of the 3 QA Operations Chapters (MAB ADC&SUT or QA SM & Direct Materials).
As Quality Assurance (QA) Managers for Direct Materials, QA Managers make a critical contribution to quality oversight for the qualification and release of raw materials. In this role, you are responsible for ensuring compliance with and continuous optimization of the quality system, always taking into account current legal and internal requirements. Through changing assignments, you expand your network and actively contribute to the harmonization of processes.
Your Profile
* University degree in a scientific or engineering field (e.g., biology, chemistry, pharmacy, biotechnology)
* At least 3 years of professional experience in quality assurance or GMP compliance, or at least 3 years in a GMP-regulated environment.
Tasks & responsibilities
* Central contact person for purchasing, QC and production companies in all quality issues, for raw material release and qualification.
* Ensuring quality oversight and GMP compliance for the raw materials and projects managed.
* Reviewing, assessing, and approving specifications, both on paper and in SAP/SLIMs.
* Responsible for the release of direct materials.
* Processing, assessing, and approving deviations, corrective actions (CAPAs), and technical change requests.
* Conducting self-inspections and supporting internal audits and regulatory inspections.
* Actively contributing ideas for continuous process improvement and supporting their implementation.
Must Haves
* Completed university degree in a scientific or engineering field (e.g., biology, chemistry, pharmacy, biotechnology).
* At least 1 year of professional experience in the field of Quality Assurance or GMP Compliance, or 3 years in a GMP regulated work environment.
* Strong team player with excellent communication skills.
* High level of quality awareness and an independent, results-oriented and assertive way of working.
* Fluent communication in German and English (spoken and written).
* Proficient in the use of common IT systems in the pharmaceutical industry.
Ready to drive quality in the heart of Basel's leading biotech? Apply today! We look forward to receiving your application.
Application Submission Deadline: 30.10.2025
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