Manager, Microbiology (CVRM)
Core
Establish and lead the QC Microbiology team to deliver safe, compliant, and efficient testing for CVRM (Cardiovascular, Renal, and Metabolism) products at a new greenfield manufacturing facility.
Role type
Manager, QC Microbiology (Greenfield Start-up)
Builds
A highly effective and engaged QC Microbiology organization capable of supporting facility, utility, and process qualifications, transitioning to routine commercial operations.
Domain
Pharmaceutical manufacturing / Microbiology / Quality Control
Required skills
Microbiology methods, laboratory instrumentation, analytical method validation, contamination control strategies, environmental monitoring, cGMP operations, ICH guidelines, global regulatory requirements, project management, budget management
Preferred skills
Greenfield project experience, Operational Excellence certification (Lean Six Sigma, 5S, Kaizen)
Technologies
Advanced automation, robotics, digital tools, real-time data analytics
Responsibilities
Champion proactive quality and safety cultures, ensure appropriate staffing and resource allocation, author and approve critical technical and compliance documents, own QMS records including investigations and CAPAs, use data-driven decision making to improve operational performance, present Microbiology topics during regulatory inspections
Seniority
Manager, hands-on IC with team leadership