Senior Director Quality Affairs

Nature and Scope Reporting to the Senior Director of Quality is a multi-disciplinary management role that will interact with all phases of production for the manufacture of sterile injectables. This position is responsible for oversight and direction for all aspects of compliance including laboratory operation, documentation, Regulatory Body Inspections (e.g., FDA, Health Canada, etc.), supplier quality, third party manufacturer quality, as well as strategic quality initiatives and continuous improvement processes. This position will interact with all levels of the organization both domestically and internationally. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. - Provides Leadership and direction for a professional team focused on quality management systems and compliance; establish and maintain performance goals, training plans, and provide regular feedback including performance plans and reviews. - Perform all duties in accordance with American Regent's Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines. - Quality Management Ownership for Deviation, CAPA, Change Control, Documentum Control, Annual Product Review Systems, Technical Services and External Manufacturers (CMO's). - Lead Quality activities to execute production records, approve executed batch records, and support release of product for shipment. - Manage and improve ARI's Quality Systems to ensure compliance with regulatory requirements and provide safe and effective products to customers. - Ensures site wide cGMP compliance in accordance with 21 CFR Parts 210 and 211, USP requirements, and other regulatory requirements. - Identify and facilitate the resolution of quality issues in conjunction with site teams. - Manage all aspects of regulatory authority inspections, and customer and corporate audits, development of responses, and execution of required improvements following such inspections/audits. - Own and support metrics-based Continuous Quality Improvement activities and Key Performance Indicators (KPI) through application of statistical methodology. - Provide oversight for review and release of commercial, R&D, and clinical study products. - Responsible for maintaining and managing communications and cross-functional activities with internal/external customers and regulatory agencies. - Responsible for continuous improvement initiatives for the site and working with other ARI locations to assure best practices and harmonization of policies and procedures. - Drives quality Culture and Core Competency Model initiatives in support of enhanced organizational performance. - Responsible for Quality Control (Stability, Chemistry, Microbiology, EM, & QC Particulate labs) for the site. - Manage and facilitate the QA Operations, QA Inspection and Finishing team to assure timely and quality oversight of production activities related to production, manufacturing, filling and transfers, inspection and packaging of sterile injectable drug products. - Partner with Production, Regulatory Affairs, Engineering, R&D and QA Compliance to strategize and organize implementation of new technology, processes and products. - Lead on-site QA activities in investigating deviations, CAPAs, or other compliance issues associated with daily inspections/packaging operations. - Write and revise SOP's and other cGMP documentation. - Ensure all work is performed and documented in accordance with existing company policies and procedures, as well as cGMP and health and safety requirements. - Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications