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
Quality Management Senior Manager in workfromhome at Unknown Company
This position is listed as full time and able to be worked remotely.