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Job #03471

About our client Our client is a specialty biopharmaceutical company that develops, manufactures and distributes best-in-class adult stem cell products. The company’s products are used for clinical applications internationally and in research studies in the United States following FDA guidelines. Position Location Director of Quality Assurance San Diego CA - South Salary Highly competitive package, commensurate with experience Responsibilities 1) Responsible for Quality Assurance required to support manufacturing 2) Work in compliance with all internal procedures and policies including FDA relative to the design and manufacturing 3) Implement and maintain all applicable procedures to comply with any related FDA, state, or federal requirements 4) Assure compliance with ISO standards and maintain certifications 5) Setup and maintain the corporate document control area with respect to compliance, and any related customer requirements including all aspects of design control 6) Develop, implement and improve new and existing product quality requirements 7) Initiate new/revised documentation and track through approval cycles and implementation 8) Develop physical and functional test methods to ensure specifications are met 9) Write, review and approve design verification and validation protocols and reports 10) Conduct and/or coordinate testing outlined in protocols and test methods 11) Conduct complaint investigations 12) Coordinate and perform internal and supplier audits 13) Provide regular reports on quality systems 14) Support and maintain any and all procedures that pertain to the interaction of employees and corporate policies 15) Assist with the research, development, and operations-related documentation for new products or product changes 16) Assist in the setup and validation of all manufacturing projects 17) Make recommendations for capital investments to maintain or improve the quality and competencies of the quality areas 18) Management of subordinate employee(s) as required 19) Participate in FDA, customer, or other inspections 20) Keep the Lab Director and other management personnel advised of any quality-related issues, problems, or potential difficulties Requirements 1) Bachelors or equivalent degree preferred (business or technical field preferred) 2) 3 to 5 years of experience in cell manufacturing preferred 3) 5 to 7 years of quality management experience