Senior Manager- Microbiology SME
Core
Global Microbiology Subject Matter Expert leading sterility assurance, contamination control, and aseptic processing reviews for sterile pharmaceutical manufacturing.
Role type
Senior Manager, Microbiology SME
Builds
Sterility assurance governance, contamination control strategies, and global microbiology investigation review processes
Domain
Pharmaceutical manufacturing (sterile), Quality & Compliance
Required skills
Microbiology, Sterility assurance, Aseptic processing, Contamination control, CAPA design, Root cause analysis, Regulatory compliance (USFDA/EU GMP), Data integrity, Risk assessment, Technical writing
Preferred skills
Advanced certification in Sterility Assurance or Pharmaceutical Microbiology
Technologies
None stated
Responsibilities
Establish and lead the Global Sterility Assurance Review Board; Strengthen global review of microbiology deviations and contamination events; Provide expert review for aseptic processing, environmental monitoring, and sterility test failures; Partner with cross-functional teams to drive investigation quality; Review microbiological trending and signals from utilities and cleaning; Support Contamination Control Strategy (CCS) review; Provide technical support during regulatory inspections; Lead cross-site knowledge sharing and training; Drive standardization of investigation review processes
Seniority
Senior Manager, 12+ years experience