Director / Senior Director, GCP Quality Assurance Lead

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director / Senior Director, GCP Quality Assurance Lead based in United States.

This senior leadership role is responsible for driving global GCP quality strategy across late-stage clinical development programs in neurology and rare diseases.
You will act as the primary quality authority for clinical trials, ensuring full compliance from study start-up through inspection readiness and regulatory submission.
The role combines hands-on quality oversight with strategic leadership, partnering closely with Clinical Development, Regulatory Affairs, and Drug Safety teams.
You will oversee cross-functional and outsourced clinical operations, ensuring CRO and vendor alignment with global regulatory expectations.
This position plays a critical role in shaping a proactive, inspection-ready quality culture across clinical programs and external partners.
You will also contribute to broader GxP oversight, including pharmacovigilance and pre-clinical quality assurance activities.