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. Accountabilities: As the senior Quality leader, you will establish and maintain robust quality systems, provide independent oversight of outsourced GxP activities, and ensure that products and operations meet applicable regulatory requirements. You will also lead quality governance, manage significant compliance risks, and develop the organizational capabilities needed to support long-term portfolio growth.

- Lead pharmaceutical quality systems: Develop, implement, govern, and continuously improve the pharmaceutical quality system, including document control, training, change control, deviations, investigations, corrective and preventive actions (CAPAs), complaints, management reviews, and product-quality reviews. - Oversee external manufacturing and testing: Provide independent Quality oversight of manufacturing, testing, packaging, labeling, storage, and distribution performed by external partners. - Manage product disposition and release: Serve as the final Quality authority for batch disposition and release within delegated responsibilities, ensuring compliance with applicable market-specific requirements, including Qualified Person certification where required. - Review and approve quality documentation: Provide timely, risk-based review of batch records, analytical results, investigations, change controls, CAPAs, specifications, validation documentation, and other records affecting product quality or disposition. - Support product and process lifecycle activities: Oversee process and analytical changes, technology transfers, validation, new product introductions, product acquisitions, and post-approval changes. - Manage external partner quality: Establish risk-based qualification, auditing, monitoring, and requalification programs for contract development and manufacturing organizations (CDMOs), contract laboratories, packaging providers, distributors, and other GxP suppliers. - Establish quality agreements: Define responsibilities, communication protocols, performance expectations, and escalation pathways with external partners. - Monitor quality performance and risks: Develop meaningful quality metrics, conduct trend analysis and management reviews, and ensure significant risks and adverse trends are escalated and addressed appropriately. - Lead inspection readiness: Serve as the primary Quality representative during regulatory inspections and health-authority interactions, overseeing inspection preparation, responses, remediation plans, and compliance commitments. - Protect data integrity: Ensure appropriate oversight of electronic records, computerized systems, documentation practices, and data integrity across internal operations and the external GxP network.