Senior Manager, Sterility Assurance
Core
Strategic leader driving enterprise-wide compliance with global sterility and microbiological standards across product development, manufacturing, and distribution to safeguard patient safety.
Role type
Senior Manager, Sterility Assurance & Microbiology
Builds
Enterprise sterilization policies, validation programs, and harmonized processes across global manufacturing sites
Domain
Medical device manufacturing / Sterilization & Microbiology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (sterilization processes & lab oversight)
Required skills
Sterilization process design, Microbiology lab operations, Regulatory compliance (FDA/ISO/EU MDR), Risk management, Team leadership, Root cause analysis, Process validation, Cross-functional collaboration
Preferred skills
Science/Microbiology degree, ISO Lead Auditor certification, Certified Quality Engineer (ASQ)
Technologies
Ethylene oxide, Gamma irradiation, Steam, E-beam, QMS systems
Responsibilities
Create and maintain enterprise sterilization policies and procedures; Lead investigations and root cause analyses for nonconformances; Partner with R&D and manufacturing to integrate sterilization into product design; Represent the company in regulatory inspections and industry forums; Drive training programs to build organizational expertise; Monitor emerging technologies and standards.
Seniority
Senior Manager, strategic leadership & team management