QA Manager - Pharma Company in MI / KS

QA Manager - Pharma Company in MI / KS Must have experience: The selected candidate is required to possess the following: * Requires a BS degree in Biology, Chemistry, Microbiology, Biochemistry or related technical field, with a minimum of twelve (12) years of work experience in pharmaceutical quality control or quality assurance. * Must have a thorough working knowledge of FDA, cGMPs GLPs, EMA, and EPA requirements. * Must have a thorough understanding of the API's, Aseptic Processing, Solid Dose, Compounding, Sterilization, and Quality Assurance processes. * Highly developed communication skills are required to communicate effectively with management and technicians. * Provides leadership and guidance to the strategic project teams on quality and compliance related matters during the planning and execution of all project activities. Works with internal and external customers and strategic partners to ensure compliance with applicable regulatory requirements. * Manages the Quality System with a focus on continuous improvement and responsibility for ensuring compliance with cGMPs, BHC GMP Directives and SOPs, FDA, EU and EPA requirements. * Manages resolution of project quality compliance and regulatory issues associated with BHC projects, external contract manufacturers and strategic third party customers. * Supports and assists in the management and facilitation of on-site inspections performed by FDA, EMA, and other regulatory agencies as well as audits by third party customers, and internal corporate auditors. * Provides quality/cGMP input and direction to meet the requirements for product development activities, QC testing, vendor approval, production processes, method and process tech transfer, process and cleaning validation, equipment qualification, training, auditing, and periodic stability review. * Develops and reports metrics and KPIs to senior management on the status of strategic project related compliance and quality and advises management of potential issues and ensures the implementation of appropriate corrective actions. * Manages the review of production, validation, maintenance, regulatory and quality data, performs trend evaluation, deviation review and development of effective CAPA, and directs cross-functional problem solving to resolve issues. * Reviews and approves Change Control Documentation which includes changes to utility systems, facilities, production processes, laboratories, manufacturing equipment, computer systems, etc

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