Director, Quality (Contamination Control and Microbial Excellence)
Core
Define and implement global policies and standards for contamination control, sterility assurance, and microbiology across pharmaceutical sites to ensure regulatory compliance and operational excellence.
Role type
Director, Quality (Contamination Control and Microbial Excellence)
Builds
Global contamination control strategies, environmental monitoring trends analysis, and facility/process design guidance for sterile pharmaceutical manufacturing.
Domain
Pharmaceutical manufacturing, GMP, sterile processing, and environmental monitoring
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Contamination control risk assessment, aseptic processing, environmental monitoring, cleanroom design, GMP compliance, regulatory inspection defense, CAPA planning, sterilization process validation
Preferred skills
CCS implementation experience
Technologies
RABS, isolators, autoclaves, SIP, filter integrity testing
Responsibilities
Develop and maintain site contamination control strategies aligned with global procedures and EU GMP Annex 1/FDA 21 CFR/ISO/PIC/S standards; Provide subject matter expertise in microbiology, aseptic processing, and environmental monitoring; Review EM trends from the PSG network and remediate adverse trends; Provide above-site support for complex deviation or laboratory investigations related to Microbiology, Contamination Control, and Sterility Assurance; Guide facility and process design including design-led contamination controls and sterilization process qualification; Support inspection readiness and digitalization initiatives.
Seniority
Director, strategy & mentorship
