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Job #02622

About our client Our client is a rapidly growing biotech company headquartered in the mid-west that is focused on the development and commercialization of various small molecule antibacterial products. The company has an experienced management team, strong momentum in their various programs and an empowering corporate culture that is focused on the professional development of its employees. Position Location Director of Quality Assurance GLP/GCP Indiana Salary Reports to Highly competitive package, commensurate with experience Management Responsibilities 1) Establish effective working relationships with key quality personnel at all CROs 2) Ensure effective management of activities, studies or services that are conducted at locations 3) Lead the effort to operate and modify (as needed) the quality agreements with all CROs such that roles, tasks and escalation procedures are clearly delineated 4) Provide information regarding resources needed for quality incorporation in annual and 5-year business plans that are realistic 5) Evaluate the quality performance of existing CROs and work with the VP, Q&C to consider actions needed to ensure quality improvements or other actions based on performance 6) Provide contingencies to ensure delivery of fully compliant reports as studies are completed 7) Ensure that the cGLP and cGCP systems of CROs are compliant with regulatory expectations and are being executed during all phases of the studies 8) Act on any quality issues arising with CROs involving studies 9) Handle the primary technical role for the quality of non-clinical and clinical documents needed to support IND and NDA applications 10) Provide regular and timely information to the VP, Q&C regarding the quality performance of CROs 11) Work effectively with all other members of the corporation to ensure achieving success as a team 12) Represent the company in discussions with regulatory agencies for pre-approval or routine inspections regarding the operations that produce product used in clinical trials or commercial purposes Requirements 1) Bachelor’s degree in scientific field/other advanced degree in Science (MS or Ph. D. helpful) 2) 10+ years of work experience in pharmaceutical quality control, quality assurance or regulatory affairs with a focus on GLP and GCP activities 3) Experience in both large pharmaceutical and start-up companies a plus 4) Knowledge of global regulatory approval and compliance processes 5) Knowledge of quality systems and working knowledge of managing quality at CROs for the delivery of non-clinical and clinical studies to support NDA submissions 6) Excellent project-management skills 7) Strong problem-solving and communication skills