Senior Manager, Quality (Sterility Assurance)
Core
Define and implement site sterility assurance policies and procedures to ensure contamination control and microbiological excellence in GMP operations.
Role type
Senior Manager, Quality (Sterility Assurance)
Builds
Sterile pharmaceutical manufacturing environments compliant with global regulatory standards
Domain
Pharmaceutical manufacturing / Sterile processing / Microbiology
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 readiness, CAPA planning, Barrier technology implementation, Microbiology methods, 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 EU GMP Annex 1 and FDA 21 CFR; Provide SME support for complex deviations and laboratory investigations; Lead training programs on aseptic practices and gowning; Ensure compliance during regulatory inspections and internal audits; Oversee Airflow Visualization studies and intervention risk assessments.
Seniority
Senior, hands-on IC with leadership responsibilities
