Microbiology Supervisor (QC Lab)

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This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Your Role
The Microbiology Supervisor leads the GMP Quality Control Microbiology department, ensuring full compliance with ICH Q7 and 21 CFR regulations for active pharmaceutical ingredient (API) testing. Key responsibilities include overseeing microbiological test methods, method validations, and tech transfers; managing OOS/OOT investigations, deviations, and CAPAs; and conducting routine training on aseptic techniques and testing procedures.
Supervise, manage, and develop a QC Microbiology team of 8–10 employees, holding full accountability for meeting business quality performance metrics and KPIs
Oversee the Environmental Monitoring Program and the Bioburden and Endotoxin Testing laboratories
Manage and prioritize laboratory testing schedules to ensure all products are released in a timely manner
Develop and implement programs to establish and maintain quality systems and product/service standards, while driving quality improvement initiatives and establishing policies, procedures, and methods to enhance product, material, component, process, and operational quality
Support and participate in client and regulatory audits
Interface with internal and external customers on a regular basis to communicate project status, resolve issues, and implement methods, techniques, and evaluation criteria for products and processes
Perform other duties as required by management
Who You Are
Minimum Qualifications:
Bachelor's Degree in Microbiology, Biochemistry, Biology, or other Life Science discipline
3+ years of experience as a quality control manager, supervisor, or lead
Preferred Qualifications:
Master’s degree in a Life Sciences discipline
Experience as a Quality Control Supervisor or Manager at a Life Sciences organization
In-depth knowledge of health authority (FDA, EMA) expectations for pharma/biotech bulk and finished product manufacturing, alongside microbiological testing requirements
Proficiency with analytical instrumentation and laboratory software
Comprehensive knowledge of ICH Q7, 21 CFR 210/211, USP, and EP pharmacopeia requirements
Proven experience working in a highly matrixed organization, preferably within a GMP manufacturing environment
Strong written and verbal communication skills, with a demonstrated ability to translate complex