Microbiology Manager

Responsibilities

• Lead day-to-day operations of QC Microbiology and Environmental Monitoring laboratories
• Oversee testing of raw materials, in-process samples, finished products, and stability batches under GMP conditions
• Approve test methods, specifications, sampling plans, and quality procedures
• Manage and assess contract testing labs to ensure compliance and quality standards
• Ensure timely review and approval of lab data and documentation prior to QA handoff
• Oversee validation and qualification of lab methods, equipment, and processes
• Promote clear communication, accountability, and collaboration across departments
• Build and develop a high-performing team through coaching, feedback, and performance management
• Align team objectives with site strategy and monitor progress through KPIs
• Enforce safety practices and ensure compliance with ALARA principles and regulatory requirements
• Drive continuous improvement, lean initiatives, and lab efficiency
• Maintain clean, organized lab spaces in accordance with 5S and inspection readiness standards
• Lead or support quality investigations, CAPAs, and deviations within QC scope
• Review and update SOPs and controlled documents to reflect current practices
• Identify and act on opportunities to improve quality, reduce risk, and optimize workflows

Qualifications

• Bachelor’s degree in a scientific discipline or equivalent experience required
• 10 years of experience in pharmaceutical quality control or microbiology
• Minimum 2 years in a leadership or managerial role
• Deep knowledge of cGMP regulations and regulatory guidelines (FDA, EU, ISO, USP)