Quality Control Lead — On-Site GMP Lab Transformation

Biogen, Inc.; Athlone; On-site; EUR 90,000 - 120,000; Full time

Job summary

Biogen, Inc. in Athlone is seeking a Quality Control Lead to drive site QC operations, ensuring EU GMP compliance and readiness for inspections.

You will lead laboratories, equipment qualification, method transfer, and release of finished products, partnering with cross-functional teams to enable scalable manufacturing and technology advances. The role requires on-site presence five days a week, with a track record in pharma/biotech analytics, environmental monitoring, microbiology, and

Qualifications

• Bachelor's degree in Science or related discipline is required.
• GMP quality control or analytical experience in pharma/biotech is essential.
• Experience with QC microbiology, method transfer and validation is required.
• Proven people and project management experience is expected.
• Ability to author and review GMP documentation and ensure compliance.

Responsibilities

• Exercise full QC authority including approval or rejection of products and materials.
• Lead establishment and ongoing improvement of site QC laboratories.
• Build, hire, and develop a high-performing QC organization.
• Support procurement, installation, and qualification of lab equipment.
• Participate in site Quality Management Review and oversee QC performance.
• Establish, implement, and maintain compliant QC systems and procedures.
• Author, review, and approve complex GMP documentation.
• Support method transfer, validation, and lifecycle management.
• Generate and assess current and future QC needs and manage the department budget.
• Maintain oversight of outsourced activities and cross-functional partnerships.

Skills

Science degree

GMP QC

Pharma analytics

People & project mgmt

QC microbiology

Method transfer

Validation

Education

Bachelor's degree in Science

Job description

Biogen, Inc. in Athlone is seeking a Quality Control Lead to drive site QC operations, ensuring EU GMP compliance and readiness for inspections.

You will lead laboratories, equipment qualification, method transfer, and release of finished products, partnering with cross-functional teams to enable scalable manufacturing and technology advances. The role requires on-site presence five days a week, with a track record in pharma/biotech analytics, environmental monitoring, microbiology, and