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| Associate Director VA Open (J#28020) Title: Associate Director Company: Thermo Fisher Scientific Location: VA 22645 Position Summary: Lead, manage and actively participate in the CDX Contract Regulatory organization, including Audit, Documentation, CAPA/Complaint Management and Value Assignment Release, with emphasis on quality in the areas of design, validation, manufacturing and support of all products produced by the CDX Contract Manufacturing sites. Provide vision, goals, policies and procedures for the Regulatory organization that support the Quality Policy and the mission and goals of the CDX Contract Manufacturing businesses and Thermo Fisher Scientific. Assure fulfillment of worldwide regulatory requirements. Assure product design and quality meets the expectation of CDX Contract Manufacturing customers. Act as Management Representative for all FDA, ISO 13485 and all other regulatory issues. Provide direct interface with the FDA and all review authorities. 1. Establishes annual Regulatory goals and objectives for the CDX Contract Manufacturing sites. Manages the preparation of financial, organizational, and facility plans for the QA/RA departments. 2. Maintains and improves the effectiveness of the Quality System. More... | |||
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