California Licensed GMP Quality Director

Job Summary

Supporting GMP clinical manufacturing operations, the full-time California Licensed GMP Quality Director will manage product release, analytical data review, and quality event approvals while ensuring compliance with applicable standards in a hybrid work environment.

Key responsibilities

• Oversee review and approval of batch records, Certificates of Analysis, and associated analytical data for GMP products
• Collaborate with Qualified Persons for batch certification and release of drug products for EU countries
• Manage and support QA contractors and liaise with internal experts and third-party vendors for quality oversight

Required qualifications

• Bachelor of Science in Biology, Chemistry, Physical Sciences, or related degree with relevant experience in an FDA-regulated environment
• Advanced degree in Pharmaceutics, Chemistry, or related field with 8+ years of progressive industry experience
• Minimum 8-10 years in GxP pharmaceutical environment with significant GMP QA experience
• Experience in Quality oversight for solid oral dosage and Biologics manufacturing
• Familiarity with electronic document management systems and Quality Management System software platforms