GCP Quality Assurance Director

Job Summary

Providing strategic leadership and oversight of GCP quality activities, the remote Associate Director, Quality Assurance GCP will ensure compliance with regulatory requirements, manage GCP audits, and drive inspection readiness for clinical development programs.

Key responsibilities

• Lead GCP quality assurance activities and manage audits of clinical sites, CROs, and vendors
• Ensure regulatory inspection readiness and prepare for FDA and other health authority inspections
• Collaborate with cross-functional teams to maintain compliance with GCP and company SOPs

Required qualifications

• Bachelor's degree in a scientific discipline; advanced degree (MS, PharmD, PhD) preferred
• 8-10 years of experience in GCP Quality Assurance within the pharmaceutical or biotechnology industry
• Experience leading or supporting regulatory inspections and audit programs
• Strong understanding of GCP regulations and global regulatory requirements
• Proven ability to manage quality investigations, CAPAs, and inspection readiness activities