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Job #03222

About our client Our client is a contract chemistry company based in New Jersey. They are a leader in providing services in organic synthesis for a variety of pharmaceutical clients. With a skilled team of scientists and professionals, coupled with solid industrial experience, a high degree of dependability and a fully equipped laboratory they ensure that all projects are delivered in full, on time and with a high degree of purity. Due to expansion, our client is looking for an experienced Director of Quality Assurance to join their team. The successful candidate will be responsible for overseeing and maintaining the Quality Assurance Program for a small scale cGMP API manufacturer. Position Location Director of Quality Assurance South Plainfield, NJ Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee/maintain the Quality Assurance Program for a small-scale cGMP API manufacturer 2) Direct the continuing review of the QA program and the formulation of new/revised procedures and quality systems to ensure improvement or enhance efficiency 3) Oversee the policies/programs of company QA activities for the Manufacturing and Analytical departments as well as periodically evaluate results 4) Oversee SOP generation and maintenance program 5) Conduct cGMP training program, documentation, change control, review and final product release 6) Handle annual system reviews 7) Oversee internal/external inspection programs 8) Supervise customer and regulatory agency audits 9) Handle customer inquiries/complaints 10) Oversee OOS, deviations, investigations and the corrective action program 11) Supervise the quality management system involving chemical manufacturing or procurement of pharmaceutical starting and raw materials, intermediates and APIs Requirements 1) Ph. D. in a related field 2) Prior experience in cGMP setting 3) Experience in running a quality unit in an R&D setting involving production of the initial batches of Phase I material