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Xencor Square1 week ago

Director, Quality Assurance (GMP)

$198,000–$235,500 year

Hybrid · Pasadena, California, United States or San Diego, California, United States

Type
Full Time
Level
Senior Level
Education
Bachelors Degree
Company size
Unknown

Job Summary

Director, Quality Assurance (GMP) leads QA oversight for GMP manufacturing and testing activities at external vendors, ensuring compliant product release, effective vendor management, and alignment with global GxP standards. The role collaborates with internal teams and external partners to drive quality systems and processes, resolves quality issues, leads root cause investigations, and ensures QA oversight across vendors. Responsibilities include QA product release activities, vendor documentation review, governing change controls and deviations, CAPA, authoring and reviewing GMP documents, maintaining SOPs, and staying aligned with regulatory expectations for pharmaceutical development and commercialization. The position involves leadership of QA staff, cross-functional collaboration, and occasional travel between Pasadena and San Diego offices. Expected base salary range: $198,000 – $235,500; eligible for bonus and equity.

Required Qualifications

  • Bachelor’s degree in a scientific discipline
  • minimum of 12 years of directly related experience
  • Quality Assurance experience in CMC manufacturing and project management experience
  • ability to communicate complex scientific issues and partner with cross-functional teams
  • travel may be required
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$198k – $236k / yr

Director, Quality Assurance (GMP) · Xencor Square

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