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.

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.

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

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