Director, External Quality Assurance (GMP)

Introduction:Xencor•Pasadena, CA

1d•Hybrid

About The Position

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. 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. 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.

Requirements

Bachelor’s degree in a scientific discipline
Minimum of 12 years of GMP Quality/CMC experience
Extensive CMO oversight
Strong leadership, governance, and relationship management skills
Exceptional relationship management skills
Ability to use written and verbal communication skills to communicate complex scientific, medical and program issues
Ability to partner with cross-functional teams from research, pre-clinical development, manufacturing, quality, regulatory and clinical development
Outstanding flexibility and adaptability suited for the changing requirements and fast pace of a small biotechnology company
Ability to demonstrate competencies applicable for job based on Xencor’s Leadership Competency Model
Ability to effectively manage others through coaching and supervision, in accordance with company policies and practices.
Ensures employee performance meets the organization’s expectations for conduct, productivity, quality, continuous improvement, and goal accomplishment.

Responsibilities

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 expectations, appraising and managing job performance, delivering feedback and coaching, and providing career development planning and opportunities.
Performs other duties as assigned.