Director, Quality Assurance - Technical

Role: Director, Quality Assurance - Technical, overseeing GMP compliance, validation, and technical quality for contract manufacturing, testing, and storage of drug substances and products up to Phase 3 validation and commercialization. Responsibilities: lead validation efforts (process, facilities, equipment, computer systems), manage and support CSP oversight, review validation plans and protocols, handle change controls, deviations, investigations, risk management, vendor qualification, and collaborate with Technical Operations. Requirements: Bachelor's in life sciences (Chemistry, Biology, Chemical Engineering preferred), 10+ years in FDA-regulated pharma/biotech industry, deep knowledge of cGMPs and validation. Preferred: Master's degree, experience with small molecule pharma, strong project management, cross-functional collaboration, and leadership skills. High-Value: GMP validation, contract manufacturing oversight, validation of processes/equipment/cleaning/test methods, experience with pharma regulations, international travel (10-25%), remote work from San Diego. Work setup: primarily remote with some travel.