Director, Quality Assurance

Xencor•Pasadena, CA

4d•$198,000 - $235,500•Hybrid

About The Position

Xencor is a public, clinical-stage biopharmaceutical company focused on developing high-potential XmAb® bispecific T-cell engagers and other engineered drug candidates. The company aims to create impactful therapeutics for patients with cancer and serious diseases. This role is responsible for the quality systems that ensure external parties (CDMOs, CROs, contract laboratories, and service providers) and internal employees operate in a compliant manner. The position involves managing four key quality programs: GMP/GLP supplier quality management, the internal audit program, the GMP training program, and quality support for Qualified Person (QP) service providers, including QP Declarations and batch certification for EU/UK clinical trials.

Requirements

Bachelor's degree in a life science, engineering, or related discipline.
More than 12 years of progressive GMP quality experience within the biopharmaceutical industry.
Demonstrated end-to-end ownership of supplier quality and audit programs.
Prior people-management experience.
Demonstrated lead auditor experience auditing GMP suppliers and/or GLP test facilities.
Experience hosting or directly supporting health authority inspections.
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.
Ability to operate effectively in a virtual/outsourced operating model with strong written documentation skills.
Ability to demonstrate competencies applicable for job based on Xencor’s Leadership Competency Model.
Ability to effectively manage others through coaching and supervision.

Nice To Haves

Advanced degree preferred.
Direct Veeva Vault experience (QMS, QualityDocs, and Training) strongly preferred.
Strongly prefer certified auditor credential (ASQ CQA, CBA) or equivalent qualification.
Experience supporting FDA and EU/MHRA inspections and partner audits.
Experience supporting commercial-stage readiness in addition to clinical-stage supply.

Responsibilities

Manage the end-to-end supplier qualification lifecycle for GMP and GLP suppliers, including assessment, risk classification, qualification, requalification, performance monitoring, and disqualification.
Maintain the Approved Supplier List (ASL) and ensure its accuracy and inspection readiness in Veeva Vault.
Apply risk-based supplier categorization aligned with relevant regulatory guidelines (ICH Q9, ICH Q10, EU GMP, 21 CFR).
Author, negotiate, and maintain Quality Agreements/Technical Agreements with external partners.
Manage the supplier audit program, including leading audits, qualifying third-party auditors, and reviewing audit reports and CAPA responses.
Provide quality input during vendor selection and contracting for sourcing and CMC/Clinical Operations.
Oversee the internal audit program, including developing audit schedules, conducting audits of internal processes, tracking findings, and driving remediation.
Manage the GMP training program and the learning management functionality within Veeva Vault Training.
Define and maintain role-based curricula and training matrices, and manage training assignments.
Develop and deliver GMP/GxP training content, including new hire and ongoing training.
Serve as the primary QA point of contact for contracted QP service providers and EU/UK importation partners.
Prepare, review, and maintain QP Declarations (QPDs) for API manufacture.
Support QP oversight expectations under EU GMP Annex 16.
Track certification and release timelines and escalate risks.
Support importation and QP-related documentation for clinical trials.
Maintain the QP-related document inventory.
Adhere to all department and company-wide policies.
Provide oversight and direction to direct and indirect reports, as applicable.
Perform other duties as assigned.