Senior Director, GMP Quality Assurance

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

We are seeking an accomplished quality assurance executive to lead pharmaceutical quality strategy and compliance across a growing biopharmaceutical portfolio. In this senior leadership role, you will provide independent Quality oversight for clinical-stage and future commercial products, ensuring adherence to global regulatory requirements and Good Manufacturing Practices (GMP).

Operating within a fully outsourced model, you will oversee external manufacturing partners, laboratories, and other regulated service providers while maintaining rigorous quality standards. You will guide product disposition, quality system governance, regulatory inspection readiness, and risk management across the product lifecycle.

Working closely with executive leadership and external partners, you will build a strong culture of accountability, transparency, and continuous improvement. This is an opportunity to influence critical development and commercial milestones while helping protect patients and preserve product quality.