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Job #02573

About our client Our client is a leading privately held pharmaceutical company with operations in over 40 countries. With marketed products, an experienced management team, and an empowering corporate culture that is focused on the professional development of its employees, this is a great opportunity for the right candidate! Position Location Senior Manager, Quality Services New York Salary Highly competitive package, commensurate with experience Responsibilities 1) Manage all QC/QA functions that are vital to ensure a high level of quality and GMP compliance 2) Handle functions such as supervision of testing facilities, test results, release of products, subcontractor audits and certifications 3) Develop and maintain specifications and procedures, provide analytical support for product development and man-in the plant audits 4) Manage all subcontract QC testing facilities 5) Review test results and release product for distribution in the US 6) Manage reviewing of out-of-specification results with testing and production facilities 7) Recommend actions and develop documentation to support decisions and regulatory actions 8) Develop and manage the vendor certification and audit program for existing and new testing laboratories and production facilities 9) Serve as QA representative in the plant during production at all subcontract manufacturers 10) Develop and implement validation of analytical methods for new and existing products 11) Manage the transfer of analytical methods to new testing facilities 12) Develop and maintain SOPs to ensure product quality and GMP compliance 13) Manage the Change Control System for all testing procedures and specifications 14) Develop and manage the stability and file retention system including certification of development of stability programs, coordination of testing, statistical evaluation of data and issuance reports 15) Review and prepare CMC information for submission to FDA Requirements 1) B.A./B.S., M.S. preferred 2) Minimum 5 years of experience in manufacturing, quality control and/or quality assurance in the pharmaceutical industry 3) Experience in aseptic processing a plus 4) Understanding and hands-on involvement with cGMP regulations 5) Excellent organizational and planning skills 6) Ability to manage people, subcontractors and projects effectively 7) Strong computer skills