Director, Quality Assurance

Role: Director of Quality Assurance overseeing GMP/GLP supplier quality, internal audits, GMP training, and QP service support in a biopharma setting. Primary objectives include ensuring compliance of external vendors (CDMOs, labs) and internal processes with GMP/GLP standards, supporting regulatory inspections, and maintaining quality systems for clinical-stage biologics. Responsibilities encompass managing supplier qualification lifecycle, leading audits, developing and executing GMP training programs, and supporting batch certification for EU/UK importation through QP interactions. Qualifications: Bachelor's in life sciences or related field; 12+ years GMP quality experience, including end-to-end supplier management, auditing, and people leadership; expert knowledge of 21 CFR, EU GMP, ICH guidelines; hands-on experience with QMS (Veeva Vault preferred), QP interactions, and supporting FDA/EU inspections. Preferred: auditor certifications (ASQ CQA), experience in clinical and commercial supply, and international audit support. Relevant biopharma specifics involve biologics, clinical-stage development (IND/Ph1-3), and QP regulatory compliance. Collaboration involves quality, CMC, clinical operations, regulatory, and external vendors. Work setup: hybrid in Pasadena or San Diego; approx. 15–25% domestic and international travel.