Quality Assurance (QA) Manager – Drug Substance | Quality Assurance (QA) Manager – Basel Drug Substance

Job Summary

This critical role places you as the Quality Assurance Manager responsible for ensuring comprehensive quality oversight within a drug substance production unit in the greater Basel area. You will be the primary contact for production teams regarding all quality matters, ranging from raw material release to final validations. Key responsibilities include ensuring strict GMP compliance, reviewing and approving manufacturing documentation (both paper and electronic MES records), and ultimately authorizing the release of manufactured active ingredients. You will also manage non-conformances, CAPAs, and technical change requests, while actively participating in quality floor walks and supporting audits. This position requires a science or engineering background coupled with 3-5 years of specialized GMP QA experience in biotechnological manufacturing, offering a chance to drive continuous process improvement in a highly regulated environment.