Key Responsibilities:The Vice President for Quality will be responsible for providing direction, management, and oversight to all Quality functions (Quality Assurance, Quality Control, Validation, and Compliance) and will establish quality and compliance standards. Specific responsibilities include but not limited to:Quality Assurance-Responsible for all quality Assurance Systems, implementation of Corporate Policies and development of Site Policies and controls for the assigned areas of responsibility.-Ensure that internal processes and metrics are aligned to create highest product quality and competitive advantage.-Strengthen Quality Systems by determining the appropriate infrastructure and resources required to achieve business objectives.-Ensure proper interface of the quality function to Manufacturing, Product Registration, R&D and Marketing.-Collaborate with manufacturing and other functions to ensure that quality standards and GMP compliance are met and maintained.-Develop and monitor appropriate metrics to track quality and process improvement.-Foster and maintain respectful relationships with the FDA, DOD and other new and potential partners and customers.Quality Control-Provide strong leadership for a GMP testing facility and QC Departments.-Ensure cGMP compliance in the testing of vaccines and other biological products.-Provide strong leadership and oversight of QC Laboratory compliance standards as well as the development of methods, protocols, and technology transfer to and from the QC Departments.-Provide leadership and oversight to provide batch release activities, assay transfer validation and stability programs.-Lead the execution of a strategic approach to new and existing programs.Validation-Oversight of production, process control and utility validation activities in support of product manufacturing for both clinical and commercial manufacturing operations in Lansing.-Lead the Validation unit with respect to ongoing development and implementation of the site Validation Master Plan and maintain the Validation Program in compliance with regulatory requirements, industry standards and best practices.The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned. EDUCATION, EXPERIENCE, and SKILLSThe ideal candidate will have:-BS degree in Engineering, Science or Operations Management; Advance Degree(s) preferred.-15+ years in a GMP Quality and Compliance biopharmaceutical environment.-10-12 years of directly related experience, including at least eight (8) years of progressively responsible management experience with at least five (5) years at the Director level.-Significant experience and knowledge in Quality Areas (Quality Assurance & Quality Control) including Validation and proven expertise in the design and implementation of quality processes in a world-class pharmaceutical/vaccine manufacturing organization.-Must have technical knowledge of product design, manufacturing, process design and improvement.-Must have a track record of success and a broad understanding of contemporary quality practices to the position.-Ability to effectively relate the quality functions to the business as a whole.-Excellent verbal and written communication skills.Physical/Mental Requirements:Type/keyboard, visual acuity, stand, walk, and sit. Use phone and computer. Work in multiple locations and with restricted access to laboratory. Organize/Coordinate, analyze/interpret, problem solve, make decisions, supervise, plan, communicate, prepare written communications, and complete written work orders

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