Sr. Director, Sterility Assurance – Global Quality Technical Operations
Core
Develop and execute a global strategic roadmap for sterility assurance, establishing Centers of Excellence and overseeing contamination control strategies for sterile manufacturing facilities.
Role type
Sr. Director, Sterility Assurance (Global Quality Technical Operations)
Builds
Global sterility assurance programs, contamination control strategies, and microbiological monitoring standards for biopharma clients.
Domain
Biopharmaceutical manufacturing, sterile fill-finish, and GxP regulatory compliance.
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategic roadmap development, global standard authoring, contamination control strategy (CCS) leadership, microbiological monitoring governance, rapid microbiological methods (RMM) evaluation, aseptic technique oversight, capital project technical consultation, regulatory inspection defense, team supervision (1-10 employees), curriculum design, industrial microbiologist mentoring.
Preferred skills
Master's degree or PhD in Microbiology/Biology, experience establishing global Centers of Excellence, expertise in lyophilization and terminal sterilization.
Technologies
EU GMP Annex 1, USP <797>/<800>, ISO 14644, PDA TRs, ISPE guidelines, automated EM data collection tools, SIP/Autoclave systems.
Responsibilities
Develop multi-year sterility assurance roadmap; Author and maintain global aseptic processing standards; Establish Global Sterility Assurance Center of Excellence; Lead Contamination Control Strategy (CCS) development; Implement bioburden reduction programs; Govern clean utility microbiological monitoring; Standardize laboratory environmental monitoring protocols; Evaluate rapid microbiological methods (RMM); Standardize disinfectant qualification programs; Design sterility assurance training curricula; Mentor site Industrial Microbiologists; Oversee aseptic gowning and media fill programs; Provide technical consultation for facility builds/retrofits; Serve as SME for regulatory inspections.
Seniority
Senior, hands-on IC with supervisory responsibilities
