Director, External Quality Assurance; GMP

Director, External Quality Assurance (GMP)

Xencor, Inc., 465 N. Halstead St., Pasadena, California, United States of America

Posted Wednesday, June 17, 2026 at 4:00 AM

Introduction:

Xencor is a public, clinical‑stage biopharmaceutical company located in the Los Angeles area (Pasadena) and in San Diego. Our focus is developing high‑potential XmAb bispecific T‑cell engagers and additional engineered drug candidates that leverage our differentiated technology platforms, and we are advancing our pipeline toward clinical proof‑of‑concept decisions. Our goal is to create high‑impact therapeutics for patients with cancer and other serious diseases.

More than 20 XmAb drug candidates engineered with our technology are in clinical development, and three XmAb medicines have been marketed by partners. For more information, please visit  We have an excellent opportunity for a Director, External Quality Assurance (GMP) to join our team.

This is a hybrid position with 2 days a week onsite from our Pasadena or San Diego, CA office

Summary:

Responsible for leading Quality GMP manufacturing and testing activities at external vendors, supporting both early and late phase development and ensuring compliant product release, effective vendor management, and alignment with global GxP standards.

Job Duties:

• Provides oversight of Quality Assurance activities at GMP external vendors for manufacturing and testing operations, ensuring compliance with global GxP regulations, quality standards and procedures.
• Oversees and/or performs QA product release activities.
• Directs support staff on performing product release activities.
• Manages and performs review and approval of GMP external vendor documentation. Directs support staff on performing vendor product documentation review.
• Participates as the QA representative for multiple products in internal and external vendor product team meetings.
• Ensures timely resolution of operational and quality issues.
• Maintains strong working relationships with vendor operational teams to ensure clarity of expectations and consistent execution.
• Fosters collaborative relationships with vendors while providing quality guidance and oversight to ensure consistent adherence to established QA standards and performance objectives.
• Evaluates vendor performance, identifies trends, gaps, and risks in day‑to‑day operations and initiates corrective actions within defined processes.
• Supports structured Vendor business reviews and performance discussions.
• Partners with Vendor Management to address performance issues and enforce accountability.
• Drives incremental improvements using existing continuous improvement methodologies and tools.
• Leads root cause analysis for recurring or critical issues and ensure alignment with established remediation processes.
• Recommends enhancements to current frameworks based on observed operational insights.
• Collaborates with cross‑functional stakeholders to ensure alignment with existing governance and operational priorities.
• Promotes a culture of quality and disciplined adherence to established processes.
• Performs data entry functions as required by procedure.
• Authors, reviews and approves various internal documents ensuring accuracy and appropriate format according to procedures.
• Manages creation and review of documents used in Good Manufacturing Practices (GMP).
• Perform QA activities such as authoring, reviewing, approving, and/or managing change controls, deviations, and corrective actions as needed.
• Assures standard operating procedures (SOPs) related to job responsibilities define the steps necessary to complete tasks.
• Maintains current knowledge of global regulatory expectations, industry standards, and emerging quality practices applicable to pharmaceutical development, manufacturing, and commercialization activities.
• Adheres to all department and company‑wide policies regarding conduct, performance and procedures.
• Provides oversight and direction to direct and indirect reports, as applicable (if assigned in the future), in accordance with the organization’s policies and procedures. The responsibilities may include, but are not limited to recruiting, training, communicating job…