QA Project Leader (Microbiology Sterility Assurance)
Core
Lead project management for quality systems, compliance, and continuous improvement in a pharmaceutical manufacturing environment, focusing on sterility assurance and aseptic processing.
Role type
Senior QA Project Leader (Microbiology/Sterility Assurance)
Builds
Quality systems, compliance programs, and operational efficiency improvements for finished pharmaceutical products.
Domain
Pharmaceutical manufacturing / Microbiology / Sterility Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Project management (PMO), GMP compliance, root-cause analysis, CAPA management, regulatory inspection support, data analysis, SOP authoring, risk assessment (FMEA), cross-functional leadership
Preferred skills
Microbiology and aseptic processing experience, Contamination Control Strategies, Aseptic Process Simulations (Media Fills), isolator technology
Technologies
None explicitly stated
Responsibilities
Manage projects focusing on deviation reduction, batch right the first time (BRFT), and batch release cycle time (CRT); oversee quality systems and metrics for GMP compliance; participate in FDA inspections and audits; consolidate quality metrics and reporting; perform root-cause analysis and recommend corrective actions; develop contingency plans.
Seniority
Senior, hands-on IC