QA Specialist (GCP)

Overview

The Senior GCP Quality Manager is responsible for overseeing Good Clinical Practice (GCP) compliance across Phase III clinical programs. The role provides quality oversight for late-stage clinical trials, including CRO and external partner management, audit activities, and inspection readiness. This position supports cross-functional clinical development activities within a mid-sized biopharmaceutical organization focused on anti-infectives.

Responsibilities

• Oversee GCP compliance across Phase III clinical programs.
• Provide quality oversight for late-stage clinical trials, including CRO and external partner management, audit activities, and inspection readiness.
• Support cross-functional clinical development activities within the organization.

Qualifications

• Non-Negotiable Skills, Qualifications, and Experience
• Minimum 7 years of experience in GCP Quality within the pharmaceutical or biot...