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Job #02369

About our client Our client is a publicly traded biopharmaceutical company headquartered in Silicon Valley that is dedicated to the development and commercialization of enhanced versions of protein-based drugs. The company has an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees. Position Location Associate Director of Quality Assurance Silicon Valley, Northern California Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee the development, implementation and management of quality systems in support of drug development activities (GCP, GMP and GLP compliance) 2) Lead the development and management of GCP and GMP quality and compliance systems and policies, including QA processes and procedures 3) Manage the day-to-day operations of the quality system with respect to the writing, review and approval of SOPs and business practices 4) Establish and manage the audit schedule and outcomes for clinical studies and manufacturing activities 5) Coordinate internal and external GXP audits, including the timely preparation of audit reports 6) Prepare/assess GXP audit findings with respect to required corrective actions 7) Ensure timely reporting to senior management and follow up 8) Perform QC review of regulatory submission documents Requirements 1) Bachelor’s degree in a scientific discipline 2) Minimum 7 years of related experience 3) 8+ years of Clinical Quality Assurance experience 4) 3+ years of experience as Quality Assurance Manager 5) Experience in quality compliance review of training files, clinical trial management and document management 6) Familiarity with Regulatory Agency authorities and third party auditors 7) Experience in conducting internal/supplier audits and inspections of manufacturing facilities 8) Knowledge of the drug development process, US/EU regulations and ICH guidelines 9) Track record of success in the management of regulatory inspections 10) Willingness to travel – up to 25%