QC Microbiology Manager — Lead Sterility & GMP Compliance

Regulatory Jobs; North Carolina; On-site; USD 120,000 - 160,000; Full time

Job summary

Regulatory Jobs seeks a QC Microbiology Manager to lead the QC microbiology team within a pharmaceutical development, manufacturing and distribution setting, ensuring compliance with FDA regulations. This role blends strategic planning with hands-on execution to establish testing timelines, execute plans and monitor results.

The ideal candidate will build and develop a team of microbiologists, implement cGMP/cGLP SOPs, and drive continuous improvement in QC operations focusing on environmental

Qualifications

• SOPs and cGMP/cGLP knowledge required.
• Strong leadership and team-building experience.
• Experience in QC microbiology methods and FDA regulatory expectations.

Responsibilities

• Write and implement SOPs for QC activities per cGMP/cGLP.
• Develop and validate test methods for raw materials, in-process and finished products.
• Establish Environmental Monitoring Program per USP/FDA guidelines.
• Lead and develop QC microbiologists, manage staffing and training.
• Support internal and external audits by customers and FDA.

Skills

SOP writing

Leadership

Quality systems

Education

Master’s or Bachelor’s degree in Microbiology or related scientific discipline

Job description

Regulatory Jobs seeks a QC Microbiology Manager to lead the QC microbiology team within a pharmaceutical development, manufacturing and distribution setting, ensuring compliance with FDA regulations. This role blends strategic planning with hands-on execution to establish testing timelines, execute plans and monitor results.

The ideal candidate will build and develop a team of microbiologists, implement cGMP/cGLP SOPs, and drive continuous improvement in QC operations focusing on environmental