Quality Management Senior Manager

Job Summary

Owning and evolving the Quality Management System, the full-time remote Quality Management Senior Manager will drive a culture of quality across the organization while managing audits, quality standards, and compliance in GCP, GMP, and GLP environments.

Key responsibilities

• Support the implementation and continuous improvement of a robust Quality Management System, ensuring it is inspection-ready
• Define and maintain quality standards, SOPs, and process documentation across various quality environments
• Lead internal and external audits and manage CAPA, deviation handling, and change control processes

Required qualifications

• 8+ years of quality experience in biotech or pharma with hands-on exposure to GCP, GMP, or GLP
• Bachelor's degree in life sciences, chemistry, or a related field; advanced degree preferred
• Direct experience managing or supporting FDA and/or EMA inspections
• Hands-on experience in QMS ownership, including building or rebuilding a system
• Prior experience at Manager or Director level in a dynamic environment