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)
Builds
Contamination Control Strategy (CCS), aseptic processing programs, environmental monitoring strategies, and risk assessments for drug product manufacturing.
Domain
Pharmaceutical manufacturing / Sterility Assurance / Microbial Control
Required skills
Contamination Control Strategy (CCS) ownership, aseptic process simulations (APS), environmental monitoring, root cause analysis, regulatory compliance (GMP/USP/EP), cleanroom engineering, sterilization processes, microbiological investigations, trend analysis
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, APS, sterilization, and cleanroom management; Act as SME for facility design, technology transfers, and contamination risk assessments; Lead investigations, CAPA, and root cause analyses; Manage environmental monitoring strategies and performance metrics; Represent Sterility Assurance during health authority inspections and customer audits
Seniority
Senior, hands-on IC