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Job #03376

About our client Our client, a newly formed entity with significant capital investments secured, is building a low-cost generic drug manufacturing platform in China to serve the US generic market. Having just completed the acquisition of an oral solid dose manufacturing facility in Suzhou, China and an API manufacturing facility in Ningbo, China they are searching for a Vice President of Quality to join their management team. This person will be responsible for the overall management of all quality functions for the company. The role is based in East Brunswick, NJ, with up to 50% travel to China required. Position Location Vice President of Quality Assurance East Brunswick, New Jersey Salary Highly competitive package, commensurate with experience Responsibilities 1) Develop and maintain quality systems for the company in compliance with US FDA regulations 2) Manage the process of reviewing and revising the quality SOPs to comply with US FDA requirements 3) Recruit and train staff to comply with US FDA standards as well as reinforce training and motivate individuals 4) Create and manage the internal/external audit programs 5) Manage the quality control function within the manufacturing facilities and generic pharmaceuticals 6) Oversee oral solids and other dosage forms as well as APIs 7) Manage manufacturing for sale into the US market from international facilities (China) Requirements 1) 10+ years of experience in quality system senior management within a US pharmaceutical manufacturing company 2) Experience in quality audits of foreign manufacturing facilities and raw materials as well as component suppliers 3) Experience in handling equipment, process and cleaning validation 4) Experience in method development transfer and validation 5) Experience in handling day-to-day QC lab operations and data management 6) Familiarity with GCPs 7) Ability to speak Chinese (Mandarin)