Qualifications8+ years of direct experience in biopharmaceuticals or related industry4+ years of managerial experienceDemonstrated knowledge of Quality Assurance Operations8+ years of experience in application of FDA/GMP regulationsStrong communication skills, tact and diplomacyDemonstrated effectiveness in multi-disciplinary teams across the organizationAbility to represent Quality function effectively with senior management and external partiesDirect manufacturing experience is strongly preferredDirect regulatory interface experience is preferredBachelor’s Degree preferably in technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering). -Data integrityResponsible for ongoing compliance with and understanding of applicable policies and procedures, including GMPPerforms in-process testing to support Quality on the manufacturing floorProvides feedback and oversight for complaints, non-conformances and deviations, identifying improvements and responding to trendsAct as authorized person for product release to marketTPM and TPC Quality management, including exception requests (ERs),change requests (CRs) and QTATests commodities and raw materials for product compliance and manages retained samples.