QC Microbiology Manager: cGMP Lead, Sterility & EM

Quanta Consultancy Services Ltd; Cork; On-site; EUR 90,000 - 120,000; Full time

Job summary

Quanta Consultancy Services Ltd. is seeking an experienced QC Microbiology Manager for an 11-month contract in Ireland, Cork. The role focuses on leading microbiology operations, environmental monitoring, and sterility testing within a cGMP framework.

The ideal candidate will have strong regulatory knowledge (FDA/EU), proven team leadership, and a mindset of continuous improvement to ensure timely, accurate results and ongoing compliance.

Qualifications

• Knowledge of FDA and European regulatory requirements for microbiological control, environmental monitoring and aseptic processing.
• Experience managing performance of team members and succession planning.
• Knowledge and experience of lean laboratory principles and continuous improvement is preferable.
• Excellent written and verbal communication skills with a customer focus and ownership of speed, quality and accuracy of delivery.

Responsibilities

• Lead the QC Microbiology team to operate in compliance with current cGMP standards, ensuring samples are tested and results delivered within specified timelines.
• Own the site environmental monitoring and utilities (water and compressed gases) monitoring programmes, including routine execution, periodic review, quarterly reporting and trending.
• Provide oversight of out-of-specification, out-of-trend and excursion investigations, including microbial identification, root cause analysis and documentation of corrective actions.
• Own and oversee sterility testing program on site related to the Drug Product Facility onsite.

Skills

cGMP knowledge

Regulatory knowledge (FDA/EU)

Team leadership

Continuous improvement

Communication skills

Job description

Quanta Consultancy Services Ltd. is seeking an experienced QC Microbiology Manager for an 11-month contract in Ireland, Cork. The role focuses on leading microbiology operations, environmental monitoring, and sterility testing within a cGMP framework.

The ideal candidate will have strong regulatory knowledge (FDA/EU), proven team leadership, and a mindset of continuous improvement to ensure timely, accurate results and ongoing compliance.