Quality Assurance Manager (Biotechnological Active Ingredient)

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) and antibody drug conjugates (ADC). 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 two QA Operations Chapters (MAB or ADC&SUT).

As Quality Assurance (QA) Managers at Basel Drug Substance, the QA Managers make a decisive contribution to quality oversight across the entire production unit. In this role, you are responsible for compliance with and continuous optimization of the quality system, always taking into account current legal and internal requirements. Through changing areas of responsibility, 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 3-5 years of professional experience in quality assurance or GMP compliance.
• At least 3 years of professional experience in a GMP-regulated work environment.
• Experience in the manufacturing of biotechnological active ingredients is required.

Tasks & responsibilities:

• Central contact person for the production plants in all quality questions, from production from raw material release through to validation.
• Ensuring quality oversight and GMP compliance in the supported productions and projects.
• Reviewing, assessing and approving manufacturing documentation, both on paper and in the electronic Manufacturing Execution System (MES).
• Responsible for the release of manufactured active ingredients.
• Processing, assessing and approving deviations, corrective actions (CAPAs) and technical change requests.
• Conducting quality inspections (Q Floor Walks) and self-inspections and supporting internal audits and official inspections.
• Actively contributing ideas for the continuous improvement of processes and supporting their implementation.

Must Haves:

• Completed university degree in a scientific or engineering field (e.g. biology, chemistry, pharmacy, biotechnology)
• At least 3-5 years of professional experience in the field of quality assurance or GMP compliance in the production of biotechnological active ingredients
• At least 3 years of experience 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

Sounds interesting? Apply Now! We look forward to receiving your application.

Application Submission Deadline: 23.10.2025