Senior Scientist QC
Core
Lead GMP compliance and quality improvement initiatives for the Quality Control (QC) organization, ensuring regulatory adherence and process reliability.
Role type
Senior Scientist QC (GMP Compliance & Quality Improvement Lead)
Builds
Reliable laboratory processes and compliant quality records for pharmaceutical/biotech manufacturing
Domain
Life Sciences / Pharmaceutical Manufacturing / Quality Control
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance assessment, deviation investigation, root cause analysis, CAPA development, regulatory requirement translation, quality risk management, inspection readiness support, cross-functional project leadership
Preferred skills
German language proficiency
Technologies
Swissmedic guidelines, FDA regulations, EU GMP, EMA expectations, ICH guidelines, US Pharmacopoeia, European Pharmacopoeia
Responsibilities
Assess QC processes against GMP requirements and implement improvements; Translate regulatory requirements into practical guidance for lab processes; Lead and write deviation investigations with CAPAs; Review and approve compliance documentation; Coach colleagues on GMP and inspection readiness
Seniority
Senior, hands-on IC
