QC Manager, Microbiology
Core
Lead and manage day-to-day operations of a Microbiology team to ensure compliance with cGMP, HSE, and regulatory requirements in a new pharmaceutical manufacturing facility.
Role type
Senior IC Quality Control Manager (Microbiology)
Builds
Microbiological testing activities including bioburden, endotoxin, environmental monitoring, and water testing for vaccine and biological platforms
Domain
Pharmaceutical manufacturing / Biopharmaceuticals
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Microbiological testing methods, cGMP regulations (EU/US), Quality Management, Risk-Based Approach, Safety Management, People management, OOS investigation, CAPA management, Equipment qualification and validation
Preferred skills
Operational Excellence, Cross-functional collaboration, KPI monitoring
Technologies
None explicitly stated
Responsibilities
Lead and manage the day-to-day operations of the Microbiology team; Drive consistent planning, execution, and improvement of microbiological testing activities; Provide strong leadership, coaching, and development to a team of QC analysts; Ensure timely investigation and resolution of Out-of-Specification (OOS) results, deviations, and CAPAs; Collaborate cross-functionally with Manufacturing, Quality Assurance, and Regulatory Affairs; Champion a culture of Operational Excellence and continuous improvement; Monitor and report on the team's KPIs; Ensure all laboratory equipment, methods, and systems are qualified, validated, and maintained; Support internal and external audits and regulatory inspections
Seniority
Senior, hands-on IC with people management