Sr. Director, Regulatory Compliance

Job description

Job Summary Responsible for overseeing and directing strategic planning for large and highly complex Regulatory –Quality- Laboratory teams; ensuring quality and compliance for applicable products, processes, and services for assigned departments. Oversee management of regulatory compliance areas that include the global regulatory/quality audit process, ethical sourcing audit process, validations, quality clinical-affairs, Quality Management Systems, and handle all staffing-related activities for these groups. Oversee management of Medline Laboratories areas including Chemistry technical development and testing teams, Microbiological technical development and testing teams, Calibrations, Lab Software Management, GLP Quality Assurance, Laboratory Operations and handle all staffing-related activities for these groups. Responsibilities: Management all of the global regulatory/quality audit process, ethical sourcing audit process, validations, quality clinical-affairs, Quality Management Systems, Risk Management process and employees. Ensure that the program remains compliant with FDA regulations, global regulations, and ISO standards. Management all of the Chemistry technical developme...