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Job #03201

About our client Our client, a privately held pharmaceutical company, is focused on the development and commercialization of innovative therapeutics for the treatment of severe cardiac diseases. Based in California, the company has a great corporate culture that makes this a fantastic opportunity for the right candidate. Position Location Quality Assurance Director California Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee QA activities of the company (including those of company projects in India) 2) Handle auditing of contract manufacturers 3) Manage the operation and maintenance of the GMP documentation system 4) Control clinical trial material release and distribution 5) Review QC testing 6) Conduct internal and supplier auditing 7) Investigate deviations and out of specification results 8) Review process batch records and release of final product 9) Manage the change control process 10) Manage the stability-testing program 11) Review process validation protocols and reports 12) Support regulatory submission activities Requirements 1) BS/MS in Biological or Chemical Sciences 2) 10+ years of experience in quality assurance 3) Experience in handing overseas projects preferred 4) Biologics or biotech experience a plus 5) Excellent communication skills (oral and written) 6) Good interpersonal skills