Senior QC Microbiology Leader for GMP Testing

Guerbet; Raleigh (NC); On-site; USD 120,000 - 170,000; Full time

Job summary

Guerbet is seeking a QC Microbiology Manager to lead all site microbiology activities, ensuring compliance with GMP, FDA, and USP standards. You will manage a team of 12–15 analysts, collaborate with Sterility Assurance, manufacturing, engineering, and QA to sustain a robust contamination control strategy.

The role emphasizes leadership, data integrity, and continuous improvement within a regulated pharmaceutical environment, with responsibilities spanning testing, documentation, and

Qualifications

• Bachelor’s degree in Microbiology.
• Minimum 10 years of hands-on microbiology lab experience in a regulated pharmaceutical environment.
• Minimum 3 years in a leadership role managing microbiology operations.
• Strong knowledge of GMP, FDA, USP and global standards.

Responsibilities

• Lead microbiology laboratory operations and a team of analysts.
• Oversee microbiological testing of raw materials, in-process samples, finished products and environmental monitoring.
• Ensure data integrity, validated methods, and timely reporting using LIMS and associated systems.
• Drive CAPA investigations and root-cause analysis for deviations and OOS events.
• Collaborate with Sterility Assurance, Manufacturing and QA to maintain contamination control.

Skills

Leadership

GMP Knowledge

Data analysis

Communication

Project management

Education

Bachelor’s degree in Microbiology

Tools

LIMS

QMS

SAP

CMMS

ERP

Job description

Guerbet is seeking a QC Microbiology Manager to lead all site microbiology activities, ensuring compliance with GMP, FDA, and USP standards. You will manage a team of 12–15 analysts, collaborate with Sterility Assurance, manufacturing, engineering, and QA to sustain a robust contamination control strategy.

The role emphasizes leadership, data integrity, and continuous improvement within a regulated pharmaceutical environment, with responsibilities spanning testing, documentation, and