Manager Quality Assurance, Microbiology (Drug Product)
Core
Manage microbial control activities for the development and commercialization of drug candidates, including environmental monitoring, contamination investigations, and audit support.
Role type
Manager, Quality Assurance Microbiology
Builds
Drug product candidates for serious diseases
Domain
Biopharmaceuticals / Microbiology
Deliverable
client delivery
Required skills
Microbial control, Environmental Monitoring data analysis, Root-cause analysis, Corrective actions, SOP review, Cleanroom gowning procedures, Regulatory inspection support, People leadership, Training development
Preferred skills
Contract manufacturing operation (CMO) audit experience, Simulated production scenario design
Technologies
None stated
Responsibilities
Manage direct reports and foster cross-departmental relationships; Observe microbial/aseptic practices in classified areas; Analyze Environmental Monitoring (EM) data and guide trending; Review microbial control documents; Provide technical expertise on contamination investigations; Conduct facility walkthroughs for inspection readiness; Support regulatory inspection logistics; Serve as subject matter expert for CMO quality audits; Ensure consistency of IOPS Microbial programs across sites; Develop microbial/aseptic training content.
Seniority
Manager, 7+ years experience
