Director of Quality Assurance – GMP/GLP Leadership & Audits

Xencor; Pasadena (CA); Hybrid; USD 198,000 - 236,000; Full time

Benefits offered by this job

401k match

Healthcare coverage

Annual bonus

Equity grant

Job summary

Xencor, Inc. seeks a Director, Quality Assurance to lead GMP/GLP supplier quality, internal audits, and GMP training in a hybrid role based in Pasadena or San Diego.

You will oversee four linked quality programs and provide QP service provider support, with substantial cross-functional interaction across regulatory and clinical teams. The ideal candidate has 12+ years of GMP quality experience in biopharma, strong leadership, and a track record of implementing robust quality systems and training

Qualifications

• Bachelor's degree in life science or related field.
• 12+ years of progressive GMP quality experience in biopharma.
• Lead supplier quality, internal audits, and training programs.

Responsibilities

• Lead GMP/GLP supplier quality management lifecycle and audits.
• Own internal audit program with risk-based scheduling and CAPA follow-up.
• Oversee GMP training program and LMS curricula for GMP roles.
• Support QP service providers, QPDs, and batch certification timelines.

Skills

GMP quality experience

Audit program management

Quality systems (QMS)

LMS training experience

Education

Bachelor's degree in life science

Tools

Veeva Vault

Job description

Xencor, Inc. seeks a Director, Quality Assurance to lead GMP/GLP supplier quality, internal audits, and GMP training in a hybrid role based in Pasadena or San Diego.

You will oversee four linked quality programs and provide QP service provider support, with substantial cross-functional interaction across regulatory and clinical teams. The ideal candidate has 12+ years of GMP quality experience in biopharma, strong leadership, and a track record of implementing robust quality systems and training