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Job #02933

About our client Our client is a privately held biopharmaceutical company focused on the research, development and commercialization of oxygen transport agents. 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 Senior Quality Assurance Manager San Diego, California Salary Highly competitive package, commensurate with experience Responsibilities 1) Ensure quality management system complies with all applicable domestic FDA-Quality System regulations 2) Update quality system procedures to maintain compliance and continual improvements 3) Manage all aspects of internal quality system audits 4) Coordinate scheduled management review meetings with senior management on a regular basis 5) Manage implementation, support and maintenance of company-wide quality objectives and goals, including analysis as well as trending of key quality system metrics (on an on-going basis) 6) Coordinate and host external FDA QSIT Quality System inspections 7) Manage all aspects of the Corrective and Preventative Action Program to ensure timely and appropriate root-cause investigation, failure analysis as well as effectiveness 8) Develop GMP training materials and conduct training sessions for quality system procedures 9) Manage all aspects of complaint handling to ensure retrieval of timely and appropriate market feedback, complaint evaluation, investigation as well as final complaint resolution 10) Participate in product development design control and improvement project activities, including risk management and product/process validation Requirements 1) Master's degree 2) 10 years of experience (analytical chemistry background preferred) 3) In-depth knowledge of GMPs, FDA, EMEA and BLA