Senior Manager Sterility Assurance
Core
Lead sterility assurance strategy and contamination control for injectable products, ensuring compliance with global GMP regulations and overseeing aseptic manufacturing operations.
Role type
Senior Manager Sterility Assurance (Quality/Manufacturing)
Builds
Sterile injectable medicines
Domain
Healthcare / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Contamination Control Strategy (CCS) development, Aseptic process validation, Environmental monitoring program management, Microbiological investigation and root cause analysis, Risk assessment for aseptic processes, Regulatory audit representation, CAPA implementation, SOP and validation protocol management, Cross-functional collaboration, Data trend analysis
Preferred skills
Isolator technology expertise, Cleaning and disinfection validation, Project management software proficiency
Technologies
MODA, Excel
Responsibilities
Lead site Sterility Assurance strategy and program ensuring EU GMP Annex 1 compliance; Develop and maintain Contamination Control Strategy (CCS); Conduct risk assessments for aseptic processes and container closure systems; Oversee environmental monitoring program; Lead microbiological investigations and CAPA; Coordinate aseptic process simulations (media fills); Support validation and qualification activities; Represent sterility assurance in internal/external audits; Collaborate with Quality, Manufacturing, Engineering, and Microbiology teams; Monitor and report sterility assurance performance metrics.
Seniority
Senior, hands-on IC with team leadership
