Director, Quality Assurance

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

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, Quality Assurance, to join our team.

This is a hybrid position with2days a week onsite from our Pasadena or San Diego, CAoffice

Summary:

Responsible for the quality systems that assure external parties (CDMOs, CROs, contract laboratories, and service providers) and internal employees operate in a state of compliance. This role is responsible for resourcing, and performance of four connected quality programs: (1) GMP/GLP supplier quality management, including qualification, periodic review, and disqualification; (2) the internal audit program; (3) the GMP training program, including onboarding and role-based curriculum/training assignment;

and (4) quality support for Xencor's Qualified Person (QP) service providers, including preparation and maintenance of QP Declarations (QPDs) and support of batch certification activities for EU/UK clinical.

Job Duties:

GMP/GLP Supplier Quality Management

• Responsible for the end-to-end supplier qualification lifecycle for GMP and GLP suppliers: initial assessment, risk classification, qualification, requalification, performance monitoring, and disqualification.
• Maintain the Approved Supplier List (ASL) and ensure qualification status is accurate, current, and inspection-ready in Veeva Vault, Xencor's quality management system of record (Vault QMS / Quality Docs).
• Apply risk-based supplier categorization consistent with ICH Q9, ICH Q10, EU GMP Chapter 7 (Outsourced Activities), EU GMP Chapter 5 (starting-material supply chain controls), and 21 CFR 210/211 and 21 CFR 58 expectations.
• Author, negotiate, and maintain Quality Agreements / Technical Agreements with CDMOs, contract testing laboratories, GLP test facilities, and quality service providers; ensure responsibility matrices are unambiguous and current.
• Manage the supplier audit program: lead audits (on-site, remote, and hybrid), qualify and direct third-party auditors, and set audit frequency by risk; review audit reports, drive CAPA responses to closure, and escalation unresolved risk to Quality leadership.
• Support sourcing and CMC/Clinical Operations partners with quality input during vendor selection and contracting.

Internal Audit Program

• Responsible for the internal audit program end to end: multi-year risk-based audit schedule, audit plans, execution, reporting, CAPA verification, and program governance.
• Conduct internal audits of GMP/GLP-relevant Xencor processes and quality systems (document control, training, deviations/CAPA, change control, supplier management, data integrity, computerized systems, product/annual quality review, and virtual-sponsor oversight controls).
• Track and trend audit findings; identify systemic issues and drive remediation with process owners.

GMP Training Program, Onboarding & Training Assignment

• Responsible for the GMP training program and the learning management functionality within Veeva Vault Training.
• Define and maintain role-based curricula and job/training matrices; execute training assignment, reassignment, and periodic requalification for all GMP-impacted roles.
• Develop and deliver new hire and ongoing GMP/GxP training content: annual GMP refresher, data integrity, deviation/CAPA and root cause analysis, change control, documentation practices, and topic-specific training driven by CAPA or regulatory change; ensure training is completed and documented prior to independent…