GCP Compliance Associate Director

Job Summary

Leading the design and implementation of a risk-based Quality Management System, the full-time Associate Director, GCP Compliance will ensure compliance across GxP functions, manage controlled documentation, and drive inspection readiness, with the flexibility to work remotely, in a hybrid model, or onsite in Philadelphia, PA.

Key responsibilities:

• Build and maintain a risk-based QMS framework aligned with ICH GCP E6(R3) principles
• Oversee controlled document lifecycles and ensure alignment with regulatory expectations
• Drive TMF oversight and ensure 24/7 inspection readiness through risk-based quality control

Required qualifications:

• Bachelor's degree in a scientific discipline
• 5-7 years in GxP quality or compliance roles, with at least 2 years in a leadership position
• Proven expertise in ICH GCP E6(R3) implementation and vendor monitoring
• Experience with TMF management and CAPA systems
• Strong understanding of GCP/GMP interfaces and regulatory inspection expectations