Quality Control Leader: GMP Compliance & Lab Strategy

Biogen; Athlone; Presencial; EUR 90.000 - 120.000; Jornada completa

Descripción de la vacante

Biogen in Athlone is seeking a Quality Control Lead to anchor site QC operations in alignment with EU GMP, FDA and global standards. You will oversee incoming inspection, materials, in-process, EM and finished product testing, ensuring inspection readiness and regulatory compliance across the site.

You will build and lead a high-performing QC team, drive lab setup and qualification of equipment, and collaborate cross-functionally to enable compliant product release and introduction of new

Formación

• Bachelor’s degree in Science or related discipline.
• GMP-compliant QC or Analytical function experience.
• Pharmaceutical/biotech analytical environment experience.
• Experience with QC microbiological analysis, method transfer and validation.
• Personnel and project management experience.

Responsabilidades

• Exercise full QC authority on product and material approval.
• Lead establishment and continuous improvement of site Quality Control laboratories.
• Build, hire, and develop a high-performing QC organization.
• Support equipment procurement, installation, and qualification.
• Participate in site Quality Management Review and QC performance oversight.
• Establish, implement, and maintain compliant QC systems and procedures.
• Author, review, and approve GMP documentation.
• Support analytical method transfer, validation, and lifecycle management.
• Generate and assess current and future QC needs and manage budget.
• Maintain oversight of outsourced activities.
• Cross-functional partnership for compliant product release and new technology introductions.

Conocimientos

Quality control leadership

GMP experience

Analytical environment experience

People management

Analytical method transfer & ;validate

Educación

Bachelor’s degree in Science

Descripción del empleo

Biogen in Athlone is seeking a Quality Control Lead to anchor site QC operations in alignment with EU GMP, FDA and global standards. You will oversee incoming inspection, materials, in-process, EM and finished product testing, ensuring inspection readiness and regulatory compliance across the site.

You will build and lead a high-performing QC team, drive lab setup and qualification of equipment, and collaborate cross-functionally to enable compliant product release and introduction of new