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Job #02957

About our client Our client is a publicly traded pharmaceutical company headquartered in Michigan with over 10 years of success in developing and commercializing nephrology and urology therapeutics. Position Location Director of Corporate Quality Assurance New Jersey and Rhode Island Salary Highly competitive package, commensurate with experience Responsibilities 1) Develop short-term and long-term goals as well as procedures that meet the organization's quality objectives and are consistent with FDA cGMP compliance 2) Participate routinely in planning and review meetings to address/solve quality issues 3) Interface with FDA and other regulatory agencies 4) Direct quality system audits, including management of staff 5) Recommend corrective action 6) Direct the development of systems for measuring compliance with the company’s quality goals, objectives and standards 7) Manage QA staff, including planning, assigning and directing work 8) Appraise performance, reward and discipline employees as needed 9) Address complaints and resolve problems Requirements 1) BS in Chemistry or Microbiology 2) 5+ years of quality management experience 3) 2+ years of people management cGMP and GLP CAPA (Corrective Action Preventative Action) systems experience 4) Quality systems professional with extensive experience in cGMP manufacturing, GLP, SOP, CAPA and FDA and managing offshore staff (India preferred) 5) Ability to manage QA managers and QC Lab Managers at multiple sites as well as take initiatives 6) Ability to work in a fast-paced, dynamic environment 7) Strong work ethics and keen attention to detail