Compliance Specialist

Job Summary

Working fully remote, the full-time Compliance Specialist will execute quality and compliance processes, manage audits and investigations, and ensure adherence to regulatory standards within the pharmaceutical manufacturing and biotechnology sectors.

Key responsibilities:

• Manage project-specific client activities, including regulatory, vendor, and internal audits
• Ensure audit readiness and contribute to quality process improvement initiatives
• Act as the primary contact for customers regarding GMP quality and manage Technical/Quality Agreements

Required qualifications:

• Bachelor's degree or equivalent relevant experience
• Minimum of 2 years of experience in a GMP manufacturing environment, preferably in clinical trials
• Experience in Quality Review of Manufacturing Records and Release Documentation
• Working knowledge of GMP regulations and ICH GCP guidelines
• Experience working in cross-functional teams in high-pressure environments