Senior Manager QC Microbiology

Responsibilities

• Lead Environmental Monitoring (EM) and Utilities Sampling programs (WFI, Clean Steam, Process Gases) in compliance with FDA/EU regulations.
• Manage day-to-day QC Microbiology laboratory operations, including sampling, testing, data review, and equipment maintenance.
• Author and review QC Microbiology Deviations, CAPAs, Change Controls, and Trend Reports.
• Build, coach, and mentor a highly efficient QC microbiology team.
• Oversee gowning and aseptic qualifications for site-wide personnel.
• Manage microbial method verification activities, including protocol approval and strategy.
• Support regulatory compliance inspections and internal/external GMP audits.
• Ensure the laboratory meets budget, cost, volume, and efficiency targets (KPIs).

Requirements

• Bachelor’s Degree or higher in Microbiology, Biotechnology, or a related scientific discipline.
• Minimum of 7 years of experience in biological drug product Quality Control within an FDA-regulated biotechnology or pharmaceutical environment.
• Minimum of 5 years of management experience, including knowledge of Data Integrity Guidance and Data Management Systems.
• Expertise in environmental monitoring, utilities sampling, and pharmaceutical microbial testing.
• Strong working knowledge of USP/EP and cGMP/EU GMP regulations.
• Proficiency with electronic systems such as LIMS and MODA.
• Proven leadership, project management, and analytical problem-solving skills.

About the Company

BeiGene is a global oncology company dedicated to discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a global team of over 11,000 colleagues, we are committed to radically improving access to medicines through bold ingenuity and a collaborative spirit.