Director of Quality Compliance

Job Summary

To ensure compliance with regulatory standards and enhance operational excellence, the full-time remote Director of Quality Compliance will build and manage the Quality Management System (QMS), oversee GxP CSV requirements, and develop Standard Operating Procedures (SOPs) while leading cross-functional quality assurance initiatives.

Key responsibilities

• Design and continuously improve the electronic QMS, ensuring compliance with GxP quality principles
• Oversee the GxP Computer System Validation (CSV) program, ensuring systems maintain a validated state and support data integrity principles
• Administer training programs and manage the lifecycle of SOPs to ensure clarity, compliance, and operational relevance

Required qualifications

• Bachelor's degree in STEM or related field, or equivalent work experience
• Minimum 10+ years of experience in quality assurance and compliance
• Hands-on experience with electronic QMS platforms, including LMS
• Strong knowledge of GxP requirements and relevant regulatory standards (FDA, EMA, ISO 9001)
• Proven ability to lead or support FDA/regulatory inspections and manage multiple projects in a regulated environment