Director, External QA (GMP) & Vendor Oversight

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

Benefits offered by this job

401k match

Healthcare coverage

ESPP

Equity grant

Annual bonus

Job summary

Xencor, Inc. in Pasadena, CA, is seeking a Director, External Quality Assurance (GMP) to lead QA at external vendors, ensuring compliant product release and alignment with global GxP standards.

This hybrid role requires 12+ years in GMP/CMC, strong leadership, and cross-functional collaboration across research, development, manufacturing, regulatory, and clinical programs. The position offers a competitive base salary, annual bonus, equity, and a broad rewards package.

Qualifications

• Bachelor’s degree in a scientific discipline required.
• Minimum 12 years of GMP Quality/CMC experience with extensive CMO oversight.
• Strong leadership, governance, and relationship-management skills.
• Ability to communicate complex scientific, medical and program issues clearly.
• Ability to partner with cross-functional teams across R&D, manufacturing, quality, regulatory and clinical development.

Responsibilities

• Oversees QA activities at GMP external vendors for manufacturing and testing operations.
• Leads vendor product release activities and reviews GMP documentation.
• Partners with Vendor Management to address performance issues and ensure QA standards.
• Drives continuous improvement and leads root cause analyses for issues.
• Maintains relationships with vendor teams to ensure clarity of expectations and execution.
• Performs change controls, deviations, and corrective actions as needed.

Skills

Relationship management

Cross-functional partnering

Leadership

Verbal and written communication

Adaptability

Coaching and supervision

Education

Bachelor's degree in a scientific discipline

Job description

Xencor, Inc. in Pasadena, CA, is seeking a Director, External Quality Assurance (GMP) to lead QA at external vendors, ensuring compliant product release and alignment with global GxP standards.

This hybrid role requires 12+ years in GMP/CMC, strong leadership, and cross-functional collaboration across research, development, manufacturing, regulatory, and clinical programs. The position offers a competitive base salary, annual bonus, equity, and a broad rewards package.