Quality Control Lead - Sterile Product Manufacturing

About the role

Biogen is looking for a Quality Control Lead for its Athlone site, responsible for the integrity and compliance of Quality Control operations. The role establishes and maintains site-wide QC processes aligned with EU GMP, FDA and global regulatory standards, covering incoming inspection, raw materials, in-process and finished product testing, environmental monitoring and utility testing. It works on site five days a week.

Key responsibilities

• Exercise full Quality Control authority and compliance oversight, approving or rejecting products and materials
• Lead the establishment and continuous improvement of the site QC laboratories
• Build, hire and develop a high-performing QC organisation
• Support procurement, installation and qualification of laboratory equipment
• Take part in the site Quality Management Review and oversee QC performance
• Establish, implement and maintain compliant QC systems and procedures
• Author, review and approve complex GMP documentation
• Manage analytical method transfer, validation and lifecycle
• Assess current and future QC needs and manage the department budget
• Oversee outsourced activities and partner cross-functionally on product release and new technology introductions

Required profile

• Bachelor's degree in Science or a directly related discipline
• Strong experience in GMP-compliant Quality Control or analytical functions
• Significant experience in a pharmaceutical or biotech analytical environment
• Personnel and project management experience
• Experience with QC microbiological analysis, analytical method transfer and validation
• Preferred: start-up experience, complex biologic method experience, advanced degree, eligibility as Qualified Person (QP), and strong budget management