QC Microbiology Manager - Lead, Lean & Compliance

Amgen Inc. (IR); Dublin; On-site; EUR 69,000 - 94,000; Full time

Job summary

Amgen seeks a Manager QC Microbiology (L5) to lead the QC Microbiology team, ensuring safety, compliance and timely delivery of testing across development and manufacturing stages. You will oversee environmental monitoring, in-process and release testing, drive continuous improvement, and maintain inspection readiness.

This role requires strong leadership, GMP documentation expertise and problem-solving abilities.

Qualifications

• Bachelor’s degree in a science-related discipline.
• 6+ years of biopharmaceutical QC, Quality Control or relevant GMP laboratory experience.
• Experience working in a regulated cGMP manufacturing/testing environment.
• Proven experience leading teams.
• Strong experience with laboratory quality systems, investigations and GMP documentation.

Responsibilities

• Lead, manage, coach and develop the QC Microbiology team.
• Ensure QC Microbiology activities are performed safely and in compliance with cGMP, cGLP, SOPs and registered specifications.
• Provide oversight of in-process, Environmental Monitoring, release and stability testing, including commercial and global release testing.
• Provide oversight of relevant analytical in-process methods.
• Ensure testing and associated GMP documentation are completed accurately and within required timelines.
• Ensure timely completion of laboratory investigations, deviations and non-conformances, including effective root-cause analysis and CAPA.
• Review and approve SOPs, investigations, trend reports, validation/verification documentation and equipment qualifications.
• Monitor laboratory and Environmental Monitoring trends and identify opportunities for improvement.
• Drive Lean, RFT and continuous improvement initiatives to improve laboratory performance and efficiency.
• Maintain inspection readiness and participate in regulatory inspections and audits.
• Manage team resources and priorities to support Manufacturing and business requirements.
• Represent QC Microbiology on cross‑functional projects and forums.
• Identify and elevate quality, compliance, technical and operational risks appropriately.

Skills

Microbiology

GMP knowledge

Environmental Monitoring

Investigation skills

People leadership

Documentation skills

Lean / CI

Education

Bachelor’s degree in science

2-3 years microbiology supervisory/management experience

Job description

Amgen seeks a Manager QC Microbiology (L5) to lead the QC Microbiology team, ensuring safety, compliance and timely delivery of testing across development and manufacturing stages. You will oversee environmental monitoring, in-process and release testing, drive continuous improvement, and maintain inspection readiness.

This role requires strong leadership, GMP documentation expertise and problem-solving abilities.