This role requires candidates who are currently authorized to work in the U.S. without sponsorship, and C2C arrangements are not accepted. This role is fully remote.

Summary
The GCP Associate Director will oversee quality assurance activities related to clinical trials, with a focus on auditing and inspection readiness. This position plays a key role in maintaining compliance with Good Clinical Practice (GCP) and applicable regulatory expectations, while also strengthening internal quality systems.

Core Responsibilities

• Plan and deliver audits covering investigator sites, contract research organizations, and internal clinical operations.

• Guide teams through regulatory inspection preparation, execution, and follow-up.

• Offer quality and compliance expertise to support partnerships, due diligence, and vendor evaluations.

• Review operational procedures and controlled documents to ensure they align with GCP standards.

• Evaluate proposed corrective and preventive measures stemming from audit findings.

• Contribute to broader quality improvement projects and compliance initiatives.

• Collaborate with colleagues across Quality, Clinical Operations, and other functions to promote consistent quality oversight.

• Provide additional support to audit programs during periods of increased demand.

Background & Experience

• Bachelor’s degree in a scientific or related discipline.

• Approximately 8+ years in clinical quality assurance, auditing, or regulatory compliance roles.

• Strong working knowledge of GCP requirements, clinical research processes, and quality systems.

• Ability to step into ongoing programs quickly and manage competing priorities in a dynamic environment.