Director, Quality Assurance

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 www.xencor.com. We have an excellent opportunity for a Director, Quality Assurance, 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 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 / QualityDocs).
• 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 escalate 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 performance of GMP activities.

QP Service Provider Support — QPDs and Certification Activities

• Serve as the primary QA point of contact for Xencor's contracted QP service provider(s) and EU/UK importation partners.
• Prepare, review, and maintain QP Declarations (QPDs) for API manufacture in accordance with Article 46(f) of Directive 2001/83/EC and, for investigational products, Article 61 / Annex 13 and Regulation (EU) 536/2014 expectations; coordinate the supporting audit evidence, GMP certificates, and manufacturing-site information required to support each declaration.
• Support QP oversight expectations under EU GMP Annex 16 (including Article 51(3) responsibilities and reliance on audits performed by third parties), and coordinate the QP’s site knowledge, audit access, and information requests.
• Track certification and release timelines against clinical supply demand; escalate risks to Clinical Supply, CMC, and Quality leadership.
• Support importation and QP-related documentation for clinical trials (e.g., EU CT number/CTIS-linked supply, RGL/import authorization prerequisites) in partnership with Regulatory Affairs and Clinical Operations.
• Maintain the QP-related document inventory (QPDs, GMP certificates, MIA/manufacturing authorizations, audit reports supporting reliance) and ensure currency ahead of expiry.

• 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.

Education/Experience/Skills:

Bachelor's degree in a life science, engineering, or related discipline; advanced degree preferred. More than 12 years of progressive GMP quality experience within the biopharmaceutical industry, including demonstrated end-to-end ownership of supplier quality and audit programs and prior people-management experience. Demonstrated lead auditor experience auditing GMP suppliers and/or GLP test facilities, including hosting or directly supporting health authority inspections.

Position also requires:

• Working knowledge of 21 CFR 210/211, 21 CFR 600s, 21 CFR 58, EU GMP Volume 4 (including Chapters 5 and 7, and Annexes 1, 11, 13, 15, 16), ICH Q7/Q9/Q10, and Regulation (EU) 536/2014.
• Practical experience with QP interactions, QP Declarations, and EU/UK batch certification and importation requirements.
• Experience owning or substantially supporting a GMP training program, including role-based curriculum design and LMS training assignment.
• Hands-on experience administering an electronic QMS; direct Veeva Vault experience (QMS, QualityDocs, and Training) strongly preferred.
• Ability to operate effectively in a virtual/outsourced operating model with strong written documentation skills.
• Strongly prefer certified auditor credential (ASQ CQA, CBA) or equivalent qualification, experience supporting FDA and EU/MHRA inspections and partner audits, and experience supporting commercial-stage readiness in addition to clinical-stage supply.
• 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.

Potential domestic and international travel for supplier and internal audits: approximately 15–25%. Occasional off-hours communication to align with EU-based QP providers, CDMOs, and contract laboratories.

Expected Base Salary Range: $198,000 - $235,500

The actual salary will be based on the selected candidate’s qualifications, including skills, competencies, education and experience. Xencor offers a competitive total rewards package including 401k match, healthcare coverage, ESPP and a broad range of other benefits.  In addition, this position will be eligible for an annual bonus and equity grant. For more information, please see https://xencor.com/careers/.

Americans with Disabilities Act (ADA) Statement

The Company will provide reasonable accommodations (such as a qualified sign language interpreter or other personal assistance) with the application process upon your request as required to comply with applicable laws. If you have a disability and require assistance in this application process, please contact HR@xencor.com.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

Equal Employment Opportunity (EEO) Statement

The Company is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender or gender identity, national origin, disability status, protected veteran status or any other characteristic protected by state or federal law.

Xencor does not accept profiles or resumes from recruiting vendors without a binding written agreement. Any unsolicited submission of services and or resumes in no way creates an obligation or duty by Xencor, implied or otherwise.