Responsible for ensuring the QMS is established and maintained in accordance with applicable regulations and standards. The QMS Coach/Leader is responsible for managing the day-to-day operations to implement and maintain effectiveness of the QMS, to support change control and to coordinate the QMS related services. Functions: Review compliance of the Quality Management System with applicable state, federal, and international regulations and standards and initiate, implement, and monitor activities to ensure the QMS meets both compliance and business needs Coach, lead, and mentor team to ensure effective change control including implementation, maintenance and improvement of processes, continued compliance and process standardization Perform internal audits to demonstrate compliance and effectiveness of the QMS Lead and support execution of facility inspections and external audits Define direction for ensuring control, transparency and availability of quality system records Maintain and improve the infrastructure required for an effective and efficient global QMS. Provide related quality management system training. Requirements: Minimum of five (5) years of experience working with quality management systems, including the design and implementation thereof, required. Broad knowledge of industries including pharmaceuticals. Experience in leadership role is desired. Excellent oral and written communication skills. Bachelor’s degree in Quality, Business Administration, Engineering or Scientific field is preferred, but will consider experience in field. Ability to adapt quickly to change and work in a rapidly changing environment. Full Benefits. Monday – Friday 8:00 am to 5:00 pm with some flexibility needed to review other shifts. 65,000 and or DOE.