Sterility Assurance Manager
Core
Establish, maintain, and improve sterility assurance strategy and contamination control at a sterile fill/finish manufacturing facility.
Role type
Manager, Sterility Assurance
Builds
Sterile pharmaceutical products via aseptic manufacturing processes
Domain
Pharmaceutical manufacturing / Gene therapy / Aseptic processing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance expertise, aseptic process oversight, contamination control strategy (CCS) development, regulatory inspection readiness, microbiological risk assessment, cleanroom qualification management, deviation investigation, SOP approval, continuous improvement leadership
Preferred skills
None stated
Technologies
None stated
Responsibilities
Promote compliance with aseptic processes and regulations (EU Annex 1, FDA guides); conduct GEMBA assessments for compliance and coaching; define and improve environmental monitoring and contamination control programs; assist with sterility risk assessments for changes and deviations; serve as SME during regulatory inspections; present aseptic observation data to leadership; collaborate on cleanroom qualification and media fill programs; support equipment and utility validation; oversee aseptic training programs; investigate aseptic failures and approve critical deviations; review and approve GMP documents; lead continuous improvement projects for cleanroom operations
Seniority
Manager, hands-on IC
