<p>We have an open position for a Director of Quality located in Irvine, California facility to oversee the Quality Department for MainPointe Pharmaceuticals, LLC.</p> <p>RESPONSIBILITIES:</p> <ul> <li>Oversight of Quality Systems at the facility ensuring all products produced consistently meet quality specifications. </li><li>Plans and directs resources and activities of the Quality Assurance functions and assures that facility-wide activities are performed and maintained in compliance with the appropriate standards and regulations. </li><li>Manages systems for raw materials, product and document review, approval, or rejections. </li><li>Oversight of Quality Control laboratory </li><li>Ensure that cGMP requirements and quality standards are recognized, understood and maintained across the facility. </li><li>Assures facility and equipment systems meet cGMP requirements. </li><li>Oversee investigations of all non-conformances (deviations, OOS) and chair's site Material Review Boards. </li><li>Establishment of raw material and finished product specifications based on regulatory requirements and customer needs and in conjunction with product development and other site quality departments. </li><li>Author and/or approve standard operating procedures, protocols, qualifications, and quality reports. </li><li>Manages customer complaint and AER systems and associated investigations, resolution and CAPA's. </li><li>Assure all employees are trained in cGMP. </li><li>Actively participate in production, quality unit, and management meetings as needed. </li><li>Development and maintenance of appropriate tracking methods for quality process improvements. </li><li>Coordinate and manage vendor audits. </li><li>Manage Annual Product Review (APR) program and assure Product Quality Reports are completed on a timely basis. </li><li>Manages the Quality Key Performance Indicator data collection and reporting in support of Management Review. </li><li>Work across all disciplines (e.g. manufacturing, clinical, R&D, etc.) to ensure that the facility maintains a state of readiness for inspection by regulatory agencies. </li><li>Serves as an interface for inspections by FDA, DEA, and other regulatory agencies and customers. </li><li>Support oversight of document control systems. </li><li>Use of statistical process control to evaluate trends. </li><li>Development and maintenance of appropriate quality agreements with customers. </li><li>Budgetary and managerial responsibility for Quality Assurance and Quality Control departments at facility. </li></ul> <p>QUALIFICATIONS:</p> <ul> <li>Bachelor's degree in scientific discipline </li><li>10+ years' related experience in a Pharmaceutical GMP regulated manufacturing environment, with a demonstrated history of progressive growth and advancement required </li><li>5+ years of management experience; or equivalent combination of education and experience </li><li>Strong commitment to quality standards with leadership and management skills. </li><li>Ability to read and interpret technical procedures, SOP's, GMP's and governmental regulations. </li><li>Strong communication skills, both written and verbal. </li><li>Possess positive qualities of effective leadership, staff motivation and conflict resolution. </li><li>Strong attention to detail and ability to multitask. </li><li>ASQC quality certifications, ISO 9000 or other Audit training preferred. </li></ul> <p>At LGM Pharma, we always take pride in putting our people first. We are an equal opportunity employer. We offer medical, dental, vision and company matching 401K. All suitably qualified candidates will receive consideration for employment based on objective work-related criteria and without regard for the following: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws.</p>