QA Sterility Assurance Lead (SAL) - Drug Product 80-100% (f/m/d)
Core
Leading the Sterility Assurance and Microbial Control Program for Drug Product Module, owning the Contamination Control Strategy (CCS) and ensuring regulatory compliance across aseptic processing and contamination control activities.
Role type
Senior Sterility Assurance Lead (SAL) / Contamination Control Strategy Owner
Builds
Drug product manufacturing processes with high sterility assurance standards
Domain
Pharmaceutical manufacturing / Aseptic processing / Microbial control
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (aseptic processing & contamination control)
Required skills
Contamination Control Strategy (CCS) ownership, aseptic process simulations (APS), environmental monitoring strategy, root cause analysis, regulatory compliance (GMP/USP/EP), cleanroom engineering knowledge, sterilization process expertise, microbiological investigation leadership, trend analysis, cross-functional collaboration
Preferred skills
German language proficiency
Technologies
GMP, USP, EP, APS, environmental monitoring systems
Responsibilities
Own and continuously improve the Contamination Control Strategy (CCS), provide technical leadership for aseptic processing and sterilization, lead investigations and corrective actions, manage environmental monitoring strategies and trend analysis, represent Sterility Assurance during health authority inspections and audits
Seniority
Senior, hands-on IC with strategic oversight
