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Job #03125

About our client Our client is a global specialty pharma and medical device company located just outside of Chicago, IL. They focus on the design, development and manufacturing of solutions to improve the safety, delivery and effectiveness of patient healthcare. Their last year annual sales hit $2.6B and they currently have 14,000 employees worldwide. In 2007, they became the world leader in specialty generic inject able pharmaceuticals. Position Location Director of Plant Quality Macpherson, Kansas Salary Highly competitive package, commensurate with experience Responsibilities 1) Coordinate and manage all plant quality functions and related activities in accordance with corporate standards 2) Ensure that proper controls are instituted and maintained for all aspects of manufacturing and development at the site 3) Maintain high quality levels while seeking to continuously improve productivity 4) Ensure comprehensive GMP compliance, manufacturing new product approvals, manufacturing quality and procedures, laboratory operations and quality planning 5) Oversee and manage complex laboratories for physical, chemical, biological, sterility, pyrogen, particulate and environmental testing 6) Establish and implement quality policies and procedures for inspecting and controlling raw and packing materials and assaying in-process and finished product 7) Ensure that all products generated conform to predetermined federal as well as corporate standards and specifications 8) Handle release or disposition of finished product (subject only to corporate quality direction) 9) Interface directly with the FDA and foreign equivalents to maintain plant/product certification to ensure new product approvals 10) Monitor and report on all activities by the plant with regulatory agencies 11) Manage disciplinary review, promotions and transfers of departmental staff Requirements 1) Bachelor’s degree in technical Science or related field (Master’s degree preferred) 2) Minimum 10 years of experience in handling plant-level departmental tasks 3) Extensive knowledge of manufacturing with specific emphasis on sterile products and aseptic processing, sterilization processes, statistical analysis and problems solving tools 4) Experience as Audit Administrator during regulatory reviews 5) Good understanding of financial planning and budget control