Quality Systems Compliance Manager

Job Summary

Leading Quality Systems and Compliance initiatives, the full-time remote Sr Manager, Quality Systems & Compliance will design and implement a Quality Management System (QMS) to support clinical development programs while ensuring compliance and inspection readiness across U.S. and global clinical programs.

Key Responsibilities

• Execute and support the ongoing effectiveness of the Quality Management System (QMS)
• Manage deviations, investigations, CAPA, change controls, and quality events in collaboration with internal teams and external partners
• Prepare the organization for inspection readiness through established quality systems and cross-functional alignment

Required Qualifications

• Bachelor's degree in a scientific or technical field with 6+ years of progressive Quality experience within a GxP-regulated industry
• Experience managing or improving a Quality Management System and supporting inspection readiness
• Familiarity with electronic quality management systems (eQMS) such as Veeva or MasterControl
• Strong understanding of global regulatory expectations and GCP/GMP principles
• Demonstrated ability to translate regulatory and quality requirements into scalable processes